Combination Products

Overview of Combination Products

Combination products are those products that are made up of two or more distinct components, each of which satisfies an intended medical purpose on its own.

Combination products can be anything from a grouping of devices and drugs, to a combination of devices and software.

In this section, we will look into the different types of combination product, their advantages and disadvantages, and the regulatory environment that governs them.

Definition of Combination Products

Combination products are medical devices composed of both drug and device components that function as an integrated whole to achieve the intended use. Such components may be device components, drugs, biologics, or any other kind of material or substance with medicinal properties. Combination products should not be confused with co-packaged products, which are two separate but related items that are conveniently packaged together to aid in their use.

The United States Food and Drug Administration (FDA) defines ‘combination product’ as a product composed of any combination of drug(s), device(s), biologic(s), or material(s) used for diagnosis, cure, mitigation, treatment or prevention of disease in humans or animals. The parts that make up such a combination product can either be physically intermingled – like a transdermal patch containing both drug and device elements –or separate but interact to achieve the intended purpose – like two separately administered drugs produced by the same drug source material and meant to interact synergistically for treating a condition.

This definition is broad enough to encompass all types and forms of combination products; however there is further distinction based on the method used to regulate them and the personnel responsible for their oversight. Combination products undergoing evaluation by FDA may either require separate review of each component by different centres within FDA (dual filed) or they may receive single review by one center (joint filed). In either case, one set of regulations applies regardless of whether they are dual or joint reviewed. It is simply the submitter’s responsibility to divide information package into appropriate parts so that it undergoes the right level of review before being approved for market entry in United States.

Regulatory Guidance and Requirements

Combination products, as recognized by FDA, are comprised of two or more regulated components such as drugs, biologics and medical devices that are separately regulated by different FDA centres. Combination products are known to offer therapeutic benefits unavailable with stand-alone devices.

The regulatory requirements for combination products depend on the unique characteristics of the product and whether the product requires approval or clearance by the FDA. The agency’s guidance document states that “in some cases, components that meet individual requirements may still be subject to additional review as part of a combination product” (FDA, 2017). Additionally, premarket review is not necessarily required for all combination products and decisions regarding what is necessary will be made on a case-by-case basis.

Ultimately regulatory guidance for combination products depends heavily on the nature of each individual product. While there may be an overarching approach to these types of medical devices from a process and regulatory perspective – e.g., defining roles and responsibilities between different legal entities including an outsourcing facility – the details related to any one specific device can vary significantly from another. Companies engaging in development, manufacture or sale of combination products should understand all relevant requirements and become familiar with current regulations to ensure compliance with governmental standards (FDA, 2017).

Design Considerations

When designing a medical device combination product, there are numerous design considerations to be taken into account. These considerations can range from the materials to be used, to the usability and safety of the device, to the regulatory requirements for medical device combination products.

This article will provide an overview of the design considerations that are typically considered when designing a medical device combination product.

Design and Development

When developing combination products, manufacturers must follow design and development processes that reflect the special considerations for safety and efficacy associated with combination products based on their intended use. Manufacturers should evaluate the risk associated with a specific device (as well as any device components) of a combination product throughout its entire lifecycle, from planning to disposal.

Manufacturers must also ensure that the design of an effective combination product is sufficiently robust to meet its intended uses while minimizing potential risks. The design should factor in all areas such as materials selection, hardware configuration, software development and verification/validation. Additionally, the designs should consider control strategies to ensure safe operation of the product over its lifetime throughout its intended use conditions which includes temperature, pressure, shock/vibration and moisture sensitivity.

Furthermore, risk controls must be integrated into a quality system that addresses specific requirements related to combination products such as document controls (e.g., SOPS), device master records (DMR) and validation testing in accordance with regulatory agencies’ guidelines. Pre-market activities such as Risk Analysis and Mitigation Strategies (RAMS), Functional Requirements Specifications (FRS) and Hazard Analysis and Critical Control Point (HACCP) evaluations are also required when necessary for certain applications to help drive compliance activities associated with combined medical devices prior to first use by end users or patients.

Testing and Validation

Testing and validation are key components in the design of any combination product that involves both medical device and/or drug components. The testing phase helps to ensure safety, effectiveness, reliability, and performance with the overall goal of helping to protect the end user and maximize patient health. Generally, device manufacturers are expected to complete two primary types of testing for combination products: Subsystem Testing to ensure safety and effectiveness at subsystem level, as well as System Integration Testing (SIT) that tests system performance as an overall integrated product.

Subsystem Testing: Subsystem designs must be tested in a systematic manner from components all the way through completed subsystems to verify electrical/mechanical/software functions in physical environments. Key tests should be performed during development activities for mechanical parts, electronic components, software coding, manufacturing processes and individual modules for biological material performance.

System Integration Testing (SIT): With SIT studies whole systems are tested by configuring hardware then simulating pre-defined patient scenarios or conditions that represent real-world use or anticipated use conditions or scenarios determined through Risk Management. Validation is critical here to check if stated requirements have been realized such as user interface verification, functional output confirmation by operators including usability analysis such as how does it work in the hands of physicians / nurses etc., safety validations such as power management for batteries etc., reliability validation & maintainability verifications with respect to service strategies identified such as calibration validations & PM cycle intervals based on cyclic loading etc., risk management related elements such suitable warnings & hazardous notifications plus desired alarms validations etc., also need to be verified while conducting SIT testing.

Labelling and Packaging

When designing the labelling and packaging for a medical device combination product, there are several important considerations. The primary goal should be to ensure that the combination product is easily identified through visual inspection as well as in other situations such as laboratory tests.

The following points should be addressed when designing labelling and packaging for a medical device combination product:

  • Ensure that the intended use of the medical device is clearly indicated on the label.
  • Present detailed instructions for mixing, calibrating, and operating the medical device in its entirety.
  • Illustrate any special precautions or warnings associated with using the medical device so that they can easily be understood by all potential users.
  • Include both visible labelling and tamper evident packaging materials to prevent misapplication or accidental contamination of components in transit or storage.
  • Accurately display expiration dates to identify when components must be replaced over time due to degradation.
  • Define colour codes, pictographs, and fonts in order to distinguish different types of devices and components across a range of conditions (e.g., normal lighting, night time settings).
  • Provide instructions on safe disposal procedures at end of life as a means of containing environmental hazards associated with decomposing materials over an extended period of time.

Manufacturing Considerations

Medical Device Combination Products (MDCPs) bring together two or more devices into a single product. When manufacturing these devices, a number of factors must be accounted for in order to ensure safety, efficacy and quality of the final product.

In this section, we will discuss the factors involved in manufacturing MDCPs.

Quality System Requirements

Medical device combination products are subject to several unique manufacturing considerations for quality system requirements that must be adhered to when pursuing ISO 13485 Quality Management System (QMS) certification. Quality systems in these settings must meet all of the requirements listed in ISO/IEC 13485, “Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.”

Quality system requirements vary based on the magnitude and complexity of the medical device combination product being manufactured. Generally, manufacturers must have a designated quality management representative responsible for developing, maintaining, and improving the organization’s QMS. Additionally, manufacturers must ensure that records demonstrating conformity with applicable design and production processes are maintained. This includes verification activities such as inspection and testing of components and process validation.

The implementation of preventive actions is also critical in prevention of issues related to medical device combines products: specific procedures should be implemented to identify root causes associated with issues (complaints, non-conformances) in order to establish corrective actions accordingly and prevent future problems from arising. In addition, there should be policies put in place outlining compliance responsibilities of personnel involved in product realization stages as well as risks posed by unforeseen events or abnormal situations during production stages are accounted for (i.e. continual monitoring). Lastly, validated methods and suitable controls should be established to measure product characteristics in-process or finished product against predetermined criteria prior to being released into market.

By adhering to these regulations and taking necessary precautions, manufacturers can effectively ensure their medical device combination products comply with all applicable regulatory regulations set forth by local regulatory offices or health care facilities.

Quality Control and Inspection

Quality control and inspection are critical elements of the manufacturing process for combination products. Quality control is the process of ensuring that all materials, processes, parts and components necessary to manufacture a medical device combination product comply with established specifications and standards. The quality assurance team should continuously assess the effectiveness of the quality management system and verify that all requirements are met throughout production.

Quality Control includes activities such as conducting audits, inspections and tests, evaluating data analysis results and performance trends, monitoring customer complaints and investigating potential product issues during development or production.

Inspections involve assessing design inputs to ensure they meet specifications and validating that processes such as assembly, sterilization or medical labelling are effective. These inspections must be conducted both in-process and upon completion of the product to ensure adherence to established requirements. All documentation should be stored securely in accordance with FDA regulations for traceability purposes in case there is a recall situation or an investigation.

Additionally Careful attention must be paid to third-party testing requirements and approved vendors record management evidence should be maintained in order to successfully receive regulatory approval for commercialization of new products.

Risk Management

The manufacturers of medical device combination products have an increased obligation to ensure that all risks associated with the product design and production, from development to post-production, are identified and managed. Risk management involves assessing the product’s design, use of components, materials, systems and processes for their potential to cause harm or damage to users or other persons in foreseeable scenarios. This requires manufacturers to take a proactive approach through risk analysis whilst ensuring that all technical documentation is kept current and consistent with the actual implementation.

Manufacturers must evaluate product safety hazards posed by medical device combination products by using various methods such as a hazard analysis (HA) process which deploys techniques such as failure mode and effects analyses (FMEA). Furthermore, Product Risk Management (PRM) techniques can be used in order to identify customer requirements, along with comprehensive analysis of customer preferences in relation to risk when purchasing the combination product. Manufacturers need consider factors such as: user interfaces; control logic; quality assurance tests; installation environment; contamination risks; product lifecycle etc. for successful risk management integration.

Additionally, mitigation measures should be put into place including but not limited to recommendations for actions doing risk acceptance/repudiation decisioning along with developing quality system procedures such as comprehensive training programs for supervisors and operators specific applicable regulations/standards impacting validation procedures while ultimately ensuring efficacy of safety mechanisms apart from assessing changes in design intention/requirements throughout production and post-production phases.

Post-Market Considerations

Medical device combination products / products composed of multiple medical device components intended to work together to achieve a medical purpose–are subject to additional post-market considerations in the United States.

Combination product manufacturers must be aware of these considerations to make sure their product meets all applicable regulations and requirements. In this article, we’ll discuss the key post-market considerations that must be taken into account for medical device combination products.

Post-Market Surveillance

Post-market surveillance is an essential element for ensuring the ongoing safety, effectiveness and quality of combination products. It involves collecting and analysing data from the market to assess these parameters and identify any risks associated with a product after it has been approved for marketing. Post-market surveillance activities can include collection of customer feedback, evaluation of product use under real conditions, analysis of adverse events reports and product performance reviews.

Post-market surveillance should be conducted at regular intervals throughout the life cycle of a combination product to ensure continued safety, effectiveness and quality. Companies should consider collecting customer feedback on their products as part of post-market surveillance in order to gain an understanding of how customers perceive their products and identify any potential issues that may need further investigation. In addition, it is important for companies to monitor adverse events related to their products in order to develop strategies for preventing harm from occurring in the future or minimize its effects should it occur. Finally, companies should review the performance of their products on an ongoing basis by comparing actual results with predictions based on pre-market data.

All post-market surveillance activities carried out by medical device combination product manufacturers must be documented clearly so that regulatory authorities are able to access information regarding how a specific product’s safety, effectiveness and quality is being monitored over time. Documentation should include details such as who was responsible for carrying out the activities, when they were performed, what methods were used and what data was collected/analysed as part of the process.

Reporting Adverse Events

Reporting Adverse Events should be part of any post-market considerations for medical device combination products. All manufacturers must report medical device related adverse events to the appropriate regulatory authority, as per regulation 803 of 21 CFR Part 803. Additionally, manufacturers of combination products regulated by both the FDA and the European Commission have unique reporting requirements set out in Chapter V of Directive 2001/83/EC.

There are numerous resources available to educate personnel within a manufacturing organization on how to properly report information regarding adverse events. Additionally, manufacturers should have rigorous processes in place to capture and assess unanticipated adverse events on an ongoing basis so that they can be accurately reported to the relevant regulatory bodies. The goal is to provide timely notice of any risks or safety concerns associated with a particular combined product as soon as possible, so that corrective actions can be taken quickly if necessary.

It’s important for manufacturers of medical device combination products to ensure that all personnel within their organizations are well informed about industry standards and regulations related to reporting adverse events. This includes monitoring manufacturer’s websites and attending relevant seminars or conferences related to post-market considerations and FDA regulations surrounding combination products. Following these procedures helps ensure prompt notification and timely assessment when unanticipated risks do arise with medical device combination products after they have been sold to market.

Post-Market Clinical Follow-up Studies

Post-market clinical follow-up studies are designed to assess the long-term safety and effectiveness of medical devices. These studies are recommended to detect potential risks associated with the use of medical devices in combination products. Study results provide essential information on product performance, including benefits or harms that may not have been detected during premarket evaluation.

Such post market clinical follow-up (PMCF) studies are typically required for class III and implantable combination products and should be performed by experienced clinical investigators, who have expertise and merit in device trials design, conduct, and analysis. Post-market clinical follow-up studies can include retrospective questionnaires, registry reviews or databases analysis – or a prospective randomized trial with extended evaluations. The type of PMCF study chosen for a device is based on its characteristics, such as frequency of usage and interaction with other critical components in the system; overall complexity; demonstrated safety benefits; patient population involved; targeted indications for use; and severity of patient illness or condition treated by the device component / component individually or in combination with other medical treatments.

Ultimately, post market clinical follow-up studies provide vital information to manufacturers so they can evaluate potential risks associated with medical device combination products that could not be detected strong during premarket evaluation. Such records also support manufacturers’ further modifications of product features in responses to post market findings. Additionally, results from PMCFs serve as an important basis on which regulatory bodies make changes to safety standards relevant to combination products containing medical devices so that end users continue derived optimum safety benefits from these combined products for improved healthcare outcomes.

Clinical Performance Plan


A Clinical Performance Plan (CPP) is a document which outlines a plan for the implementation of clinical outcomes that are associated with successful performance in a clinical setting. It is created to help health care teams achieve their clinical objectives and provide a system for measuring, monitoring and evaluating the performance of their clinical activities.

The CPP is designed to help teams develop goals and plans for improvement, and to make sure everyone is on the same page in the healthcare setting. This introduction will provide an overview of the CPP and its importance in the clinical setting.

Definition of Clinical Performance Plan

A Clinical Performance Plan (CPP) is a structured and formal process that enables healthcare providers to consistently evaluate their performance and make necessary improvements to their care and treatment delivery. It is an essential part of the Quality Improvement Program and can be used to enhance patient outcomes, reduce medical errors and optimize the effectiveness of clinical practice.

Within the CPP, measures are established by a professional team to determine set performance standards within the healthcare organization. The plan must include specific objectives, strategies, evaluation criteria and procedures to assess quality improvement processes while focusing on patient safety. Quality assurance activities must be included in order to identify areas of improvement, opportunities for efficiencies as well as ensuring compliance with administrative regulations, practice guidelines and standards of care.

The implementation of CPPs helps ensure that healthcare organizations operate in an effective manner by encouraging open communication among providers, establishing expectations related to performance standards, improving efficiency and providing consistent quality services that comply with regulatory guidelines.

Benefits of a Clinical Performance Plan

A Clinical Performance Plan is a strategic assessment that focuses on improving professional practice, facilitating collaboration across clinical teams, and increasing patient safety. There are many benefits to having a Clinical Performance Plan in place, from improving standards of care to fostering communication between clinicians and patients. By understanding the components of a clinical performance plan and the advantages that it can provide, healthcare providers can use these practices to create plans that are beneficial for their patient populations and their organizations as a whole.

The primary benefit of an effective Clinical Performance Plan is increased safety for patients. By establishing clear performance goals with defined action plans, healthcare teams are better equipped to address any issues or concerns that may arise with their patients’ care. Additionally, each team member has specific established roles and responsibilities which can help reduce errors in treatment as well as prevent conflicts between members of the team during patient care activities. Additional benefits include providing teams with more detailed information about what they need to do each day while working together in an organized manner to meet patient needs. Furthermore, it allows teams to identify areas for improvement by actively monitoring changes in patient outcomes. Finally, this plan includes developing goals for specific health system objectives such as cost reduction and quality improvement – two issues often at the top of most health administration’s agendas.

Designing a Clinical Performance Plan

Designing a clinical performance plan is an important way to ensure that healthcare professionals are performing up to their highest standards of care. A clinical performance plan helps to identify areas for improvement and opportunities for development, so that healthcare professionals can achieve their full potential.

This article will look at the key components of designing a clinical performance plan and its ultimate purpose.

Set goals and objectives

Creating effective and achievable goals and objectives is the basis of any successful clinical performance plan. Setting meaningful, measurable outcomes can help ensure that the needs of patients, the organization, and practitioners are appropriately addressed.

At a minimum, a goal should be Specific, Measurable, Attainable/Achievable, Realistic/Relevant, Time-Based (SMART). The desired outcome should also be defined in order for your staff and management to know what success means. Goals must be specific enough to facilitate evaluation once complete or at set milestones, with clear details including who is responsible or accountable for each goal.

Objectives should be S.M.A.R.T – Specific, Measurable, Achievable/Attainable/Adaptive to Change (if necessary), Realistic/Relevant to Role/Organization & Time-based – and support each goal in order to promote successful implementation of the plan within specific timelines. Objectives should also provide an opportunity for staff members to grow professionally in their role as well as align with any existing guidelines or regulations set forth by outside organizations such as The Joint Commission (TJC). To ensure success management must consider best practices along with direct input from front line providers when creating objectives associated with each goal being addressed through the plan being created.

Identify key performance indicators

For any medical or healthcare-based organization, performance improvement is essential to the ongoing success of their operations. The goal of designing a clinical performance plan is to set and measure standards by which an organization can gauge and track its performance over a given period of time. To achieve this, identifying key performance indicators (KPIs) is an important element which should be included in any clinical performance plan.

KPIs are specific metrics that serve as measurable outcomes for assessing and improving the efficiency, quality, cost effectiveness, and other aspects of healthcare delivery. KPIs may include indicators such as safety ratios, patient satisfaction ratings, staffing levels in relation to patient loads and medical error rates. Financial indicators can also be relevant KPI measures such as cost per unit of care and revenue generated by certain services or treatments performed by providers.

By understanding the key challenge areas within your organization such as operational excellence and financial optimization you are better placed to identify the right KPIs for your institution through systematic evaluation of current practices combined with an understanding of best practices across similar healthcare organizations within your field. A well-defined set of KPIs will define the range against which benchmarks can be established and tracked over time; it is ultimately these benchmarks that matter when assessing organizational performance within different areas, enabling you to make data driven decisions on how best to improve patient care delivery results as well as overall cost-effectiveness.

Develop an action plan

Creating an action plan is a critical step in your strategy for designing a successful clinical performance plan. It sets the context and provides a framework for the entire initiative. It should identify the specific objectives of your clinical performance improvement project and lay out clear steps for achieving those goals.

Your action plan should include both long and short-term objectives, with measurable results. These objectives might include improving patient outcomes through timely, efficient care; reducing operational costs; or developing new procedures to improve processes, such as managing healthcare IT systems more efficiently or delivering more efficient care in a cost-effective manner.

The success of your action plan will depend on how well you can measure rewards and successes. Results may be tracked through surveys or focus groups conducted by management in order to determine if the right initiatives were taken to secure improved outcomes. The goal should be to ensure that clinical performance measures are being closely followed while providing feedback on what is working and what needs improvement.

You should always have contingencies in place in case something doesn’t go according to plan. An effective contingency plan will always involve gathering feedback from staff members who have implemented strategies that have worked well before, as well as identifying gaps between current strategies and desired outcomes so that additional plans can be formulated if needed or desired shifts occur over time. Having leading practices in place for anticipating any contingencies is particularly important when designing plans for complex processes or multiple scenarios that could arise over time due to external forces or other unexpected events.

Implementing a Clinical Performance Plan

Implementing a Clinical Performance Plan can help ensure that staff are adhering to the institution’s standards and protocols. It is important to create a comprehensive plan with specific expectations that are clear and attainable. A Clinical Performance Plan can help motivate staff to do their best, while addressing areas that need improvement.

This article will provide an overview of the steps you need to take when implementing a Clinical Performance Plan.

Assign roles and responsibilities

When implementing a clinical performance plan, it is important to assign roles and responsibilities that involve the professionals in healthcare delivery. This will ensure that all members of a healthcare team understand their roles and responsibilities when delivering care.

The healthcare team should be made up of members with experience in different specialties within the clinical setting. Depending on the size and scope of the project, there may be additional stakeholders involved such as patients, families, payers, or other external entities. Each individual should have well-defined tasks and responsibilities that are aligned with the overall goal of the project.

Each member should have clear goals and objectives with measurable outcomes. It is also important to consider how roles might overlap between members in order to maximize efficiency. For example, some individuals may perform multiple functions or collaborate on tasks together to ensure quality care is provided to patients and positive outcomes are reached in a timely manner.

It is also important to consider potential challenges that could arise throughout the process by taking into account any ethical concerns or potential conflicts between those who hold different specializations within a health team. In addition, resources such as time, personnel, and financial resources should also be allocated for each member’s role before implementation begins. This will help ensure each individual can focus their efforts on achieving project milestones efficiently and successfully.

Establish a timeline

The timeline for implementing a clinical performance plan should be established in order to ensure the success of the initiative. An effective timeline should be established well before the start of any specific activities, and should facilitate collaboration between all stakeholders. Each step of the process, from its conception to implementation, should have a defined timeline for completion.

The first step is to identify any necessary resources that are needed to complete the project. This includes any personnel that may need to be hired or trained, as well as equipment and technology that may be required. Once these resources are identified, their availability must be considered in order to establish an appropriate timeline.

Next, detailed activities need to be established and agreed upon in order to move forward with implementation. These activities will vary depending on the specifics of each initiative but can include steps such as team meetings, grant development and submission paperwork filing, trainings conducted by department members or external vendors and system development or testing. At this stage timelines can also begin to include estimates on how long each activity might take.

It is also important at this stage for responsibilities among team members and departments to be assigned so that everyone understands their role in making sure activities are completed on time. Finally a review process should be established during which all stakeholders come together regularly in order to assess progress and make any changes if necessary.

Monitor progress

Monitoring progress is an essential element of a successful clinical performance plan. Progress should be monitored and measured on a periodic basis to measure the effectiveness of the plan and assess whether any adjustments need to be made. The desired outcome should be predetermined, as well as how progress will be measured and how often progress assessments will occur.

A range of monitoring approaches can be employed to capture data on progress such as feedback from stakeholders, performance audits and reviews, surveys or interviews with participants, focus groups involving staff members, and health records. Formal assessments may need to take place after each stage of the clinical performance plan has been implemented in order to determine whether the desired outcomes have been achieved. Additionally, informal feedback from staff can also provide valuable insights into how well the plan is being implemented.

Data gathered when monitoring progress should then be analysed in order to assess whether changes or modifications are needed for the plan going forward. This could include making changes to goals or targets for specific practices, creating better communication systems between stakeholders or clinicians involved in implementation processes, revising allocation plans for resources depending upon completion results, or reconsidering timing for when objectives should be achieved.

Through continuously monitoring and evaluating the effectiveness of implementation actions taken under your clinical performance plan using varied methods , you can accommodate challenges in implementation processes effectively while continuing on your path towards successful completion of your ultimate objectives overall.

Evaluating a Clinical Performance Plan

Clinical performance plans provide organizations with insight into the performance of staff over a period of time. These plans allow for goal setting and expectations to be set and tracked for clinical staff.

Evaluating a clinical performance plan can be a daunting task, but when done properly, it can ensure that clinical staff are meeting standards and providing adequate care.

Let’s take a look at what goes into evaluating a clinical performance plan.

Analyse data and results

Analysing data and results is an important part of the clinical performance plan. This includes collecting information, tabulating the data and analysing it to determine if goals have been met. The process allows for identification of areas that need improvement, additional training or oversight and analysis of trends to shape current practice.

Data analysis should include a review of each element in the performance plan as well as an overall look at trends across all elements. During this process, potential problems may be identified and strategies for addressing them determined. This data can also be compared with external benchmarks such as national averages or industry standards to identify areas for improvement.

Using analytical tools such as data visualization and Dashboards helps to quickly identify areas that need immediate attention and identify patterns across elements in the performance plan. It is important to focus on root causes when analysing data, not just symptoms, to ensure accurate diagnosis of any issues or opportunities identified in the analysis phase of clinical performance planning.

Identify areas of improvement

When evaluating a clinical performance plan, the first step is to identify areas for improvement. Effective analysis of the current plan helps stakeholders to understand what has worked well and what could be improved. It is important to look at the effectiveness of each component of the plan and consider ways to ensure that it is efficiently meeting its goals and objectives. Additionally, you should take into account any changes in practice environment or technology that could impact delivery of care or care outcomes.

After identifying any areas for improvement, healthcare organizations will need to develop strategies for implementing these changes. This should include a comprehensive assessment of available resources and require collaboration among internal departments and other stakeholders such as government agencies, community groups, and professional organizations. Organizations should also assess potential risks associated with any proposed changes, as well as consider how those risks can be mitigated.

Once strategies have been developed, it is critical to establish timelines outlining when these changes will take effect and provide evaluation tools so that their effectiveness can be tracked along the way. It is important to evaluate outcomes on an ongoing basis so that adjustments can be made as necessary. Finally, it is beneficial to review current goals regularly with stakeholders so that they remain aligned with changing healthcare needs and regulations within the industry.

Adjust plan as needed

After your clinical performance plan is finalized and implemented, it is important to monitor the progress. The best way to do this is to measure key objectives and determine whether those objectives are being met according to the timelines set in the plan. Regular review and assessment not only allows you to make adjustments as necessary, but also serves to validate progress made toward desired clinical outcomes.

The frequency of evaluation should be based on your practice’s goals and the complexity of the plan. The evaluation process should involve stakeholders from all levels of your organizational hierarchy. Objectives such as patient satisfaction, clinical team coordination, financial performance and administrative effectiveness should all be carefully considered when evaluating performance plans. This enables you to identify both strengths and weaknesses in systems previously put in place, as well as make changes that have a positive impact on overall outcomes.

To ensure accuracy when measuring both short-term objectives and long-term goals, use various data sources such as internal reports or patient reviews. Analyse this data regularly (e.g., weekly, quarterly or annually) and look for patterns or anomalies that may help uncover areas for improvement or further upstream issues that require more attention or resources than originally planned for. Then consider ways of addressing any issues uncovered with evidence-based strategies tailored to your specific practice needs and challenges.


After working through and assessing the Clinical Performance Plan, it is clear that there are many advantages to incorporating this plan into our organization. This plan promotes the continued professional growth of nurses and provides them with the necessary tools to progress their skills and increase their knowledge base. Moreover, the use of this plan has been proven to be beneficial in meeting the expectations of the hospital and its patients.

Let’s delve into how this plan is advantageous to our organization.

Summary of Clinical Performance Plan

This Clinical Performance Plan has provided a comprehensive overview of the overall plan for improving clinical performance. The plan has been designed to ensure that current clinical protocols and protocols of the future are focused on providing safe, high-quality care to patients. It includes an assessment of current practices and processes, as well as strategies for achieving desired outcomes. It outlines roles and responsibilities, case selection criteria, performance metrics and other key elements important in the development of a successful clinical performance improvement plan. Additionally, it provides guidance on how to involve stakeholders in each step of navigating through this process.

In conclusion, this Clinical Performance Plan will ensure that all stakeholders across an organization have the necessary information and resources to contribute towards better outcomes for every patient under its care. Implementation will also help improve operational efficiency, strengthen motivation and accountability, increase knowledge sharing among all staff members as well as establish sustainable systems for quality improvement throughout an organization’s entire healthcare system.

Benefits of Clinical Performance Plan

A Clinical Performance Plan (CPP) is a roadmap to better clinical outcomes, patient satisfaction and improved health outcomes. It helps guide healthcare teams by providing a framework within which care can be managed and, when necessary, remodelled. The CPP is based on evidence-based decision making, meaning that the plan is created using data and research to provide the best quality of care.

The implementation of a CPP offers multiple benefits to healthcare teams and their patients. Clinical performance plans are structured solution-based documents that can lead to better patient-provider dialogue and improved outcomes. The plan provides guidance for decision making throughout the course of care, assigning clear responsibilities to clinicians such as physicians and nurses. It also institutes consistent treatments in practice across health systems or departments in a hospital or clinic setting, as well as optimal processes for managing clinical information systems such as electronic medical records (EMRs). Additionally, the CPP makes it easier for staff members to work collaboratively when caring for their patients.

Moreover, improved communication among providers helps prevent medical errors due to misinformation or lack of knowledge about each patient’s individual case management needs. And finally, with clear performance goals set out in the CPP document, providers are held accountable while working within a unified system towards optimizing resources such as time and money while delivering quality care that centers around a patient’s wellbeing above all else.

Clinical Evaluation

Definition of Clinical Evaluation

Clinical evaluation is a process by which the safety and efficacy of medical products are assessed based on scientific evidence. It involves examining existing scientific literature, researching published data and reports, and collecting data from patients who have used the medical product in question. Through clinical evaluation, healthcare professionals can make informed decisions when prescribing medications or recommending medical procedures.

Let’s explore the definition of clinical evaluation in more depth.

Clinical Evaluation Process

Clinical evaluation is a systematic process of collecting and analysing data from scientific studies and other sources. It is used to assess the safety and effectiveness of medical devices, drugs, medical procedures, or treatments. The process often involves physical examinations and laboratory tests in addition to a review of pertinent literature.

The aim of the evaluation is to ensure that any newly introduced technology meets needed safety and efficacy standards before it can be used by healthcare providers or consumers. Clinical evaluations are conducted nationally by organizations such as the U.S. Food and Drug Administration (FDA), as well as internationally by groups such as the International Medical Device Regulators Forum (IMDRF).

International consensus standards provide guidelines on how a clinical evaluation should be performed, including design considerations, implementation processes, reporting formats, and interpretation principles. These guidance documents also describe what type of data needs to be gathered in order to assess a product’s safety or effectiveness prior to its distribution on the market. This type of data may include clinical studies with human subjects, pre-clinical evaluations with animal models, biocompatibility testing for device materials, software programs for devices such as medical software applications or medical devices with embedded software components, case reports submitted after a product has been marketed, reviews of published literature related to potential new uses or applications for an existing product; and periodic post-market surveillance activities in order to monitor device performance after it has gone through market approval processes.

Purpose of Clinical Evaluation

Clinical evaluation is an important component of assessing the safety and efficacy of a medical device. It is the process of collecting and analysing data to evaluate the performance of a device against predetermined performance criteria.

This process is used to determine if the device is fit for its intended purpose, and will help inform decisions about whether or not the device is safe for use. It is a critical step in the development of any medical device.

Assessing the Safety and Performance of Medical Devices

Clinical evaluation is a vital process in ensuring safe, effective, and high-quality medical devices. Clinical evaluation is the process of proactively assessing a device for safety and performance based on scientific evidence gathered from the literature, laboratory testing, and clinical experience. Clinically evaluating a medical device helps assess its risk/benefit ratio to ensure it is safe to use under normal conditions and will meet patient needs.

The purpose of clinical evaluation is to carefully assess how a medical device could cause harm, considering both observed and potential risks throughout its lifecycle. This includes considering design flaws that may put users at risk or lead to failure. It also includes understanding the effects of environmental factors (such as humidity or temperature) on the device’s performance. Additionally, clinical evaluation evaluates how well the product works in terms of its intended use under real-world conditions. Finally, clinical evaluation helps identify areas where additional research or interventions may be necessary to reduce risk or enhance the product’s efficacy.

There are several steps involved in performing a successful assessment for any given medical device: collecting data from relevant sources such as scientific studies or patient records related to similar products; studying current technology used by other organizations; conducting field trials with real users; developing test protocols; generating detailed reports summarizing analysis; identifying ways to reduce risk or increase beneficial features; establishing regular post-market surveillance programs; and continually improving product design over time as new evidence accumulates from available studies or customer feedback. The goal of clinical evaluation is always the same: make sure the product meets its intended purpose safely for long-term use without compromising user safety or performance quality.

Assessing the Risk of a Medical Device

When a medical device is developed, it must be clinically evaluated to assess its safety and effectiveness. The clinical evaluation is an assessment process used to ensure that the risks associated with a medical device are acceptable in comparison to its benefits. This evaluation should be based on the best available scientific evidence, such as pre-clinical and clinical data.

Clinical evaluation should begin at the early stages of product development and continue throughout the life cycle of the medical device. It must take into account all relevant aspects related to patient use, such as ergonomic design, user training requirements, potential user error, packaging or labelling information, operability and compatibility with other products or equipment in use. Clinical evaluations determine whether or not a medical device will pose an unacceptable risk of harm or injury when used according to its intended purpose. They also allow manufacturers to demonstrate compliance with European Medical Device Regulation (MDR) requirements for safety and effectiveness.

By evaluating all potential risks associated with a product prior to placing it on the market for commercial sale, manufacturers can ensure their products provide patients with safe and effective treatments. To understand how these clinical evaluations are conducted and what types of assessments manufacturers must complete prior to receiving MDR certification, consider this guide a helpful resource!

Clinical Evaluation Report

Clinical evaluations are important tools used to assess and document the safety and efficacy of medical devices. They involve the analysis of clinical data to determine if the device performs as intended and meets the user’s needs.

This section will cover the different components of a clinical evaluation report and discuss the key principles for writing one.

What Should be Included in a Clinical Evaluation Report?

A Clinical Evaluation Report (CER) is a document which provides an overview of a medication’s safety, effectiveness, and quality in relation to an individual patient or group. A CER may consist of various elements including an assessment of the safety and efficacy of the drug, risk factors associated with its use, clinical studies data, as well as evidence of any known adverse events or side effects experienced by patients taking it. Additionally, a CER will typically include a review of the patient’s medical condition prior to treatment and describe how their condition has responded to therapeutic interventions.

It is important that clinicians accurately report all relevant information on the safety and efficacy of medications so that healthcare providers can make sound clinical decisions and increase adherence among their patients. The information provided by a CER should be thorough and comprehensive in order to reduce risk factors associated with prescribing or administering drugs to individuals.

The following components should generally be included in a Clinical Evaluation Report:

  • Background information about the drug including its name and manufacturer
  • A comprehensive description of therapeutic outcomes for patients taking the drug
  • Clinical trial data regarding efficacy and safety issues regarding how it works
  • Risk/benefit evaluation describing potential adverse events due to using the drug
  • Follow up/surveillance plans implemented to monitor any effects post treatment
  • Evidence describing how well patients adhere to treatment guidelines when taking medication

How to Prepare a Clinical Evaluation Report

A Clinical Evaluation Report (CER) is an important quality assurance document submitted to regulatory agencies for a variety of medical device applications, such as premarket certification and registration. This type of report provides sufficient documentation from clinical studies conducted on the medical device or system, so that its effectiveness in fulfilling the intended use may be confirmed by both regulators and users.

The CER should clearly describe the results of preclinical trials containing evidence that supports how a device has been designed, manufactured, tested and its safety performance. The content should include two core elements: an executive summary and technical evidence report. The executive summary outlines the key findings, methodologies utilized, calculations made and the conclusion derived from the data presented. The technical evidence report contains all details collected during the course of study including raw data points used in clinical assessments.

The amount of detail included depends on both type of clinical trial and device class assessed. In some cases large amounts of detailed information may need to be submitted to regulatory bodies if there is a possibility for significant risk associated with use. If a device will be managed according to ISO 13485 without any direct contact with patients or healthcare professionals then minimal information is usually necessary for evaluation purposes compared to more complex higher-risk products like implantable devices or active diagnostic systems which require more rigorous scrutiny by regulatory agencies prior to approval or certification being granted. It is always important that CERs are tailored according to specific needs depending on what sort of application they’re being prepared for!

Clinical Trials

Clinical trials are conducted to evaluate the safety and efficacy of new drugs and treatments. They involve collecting data from participants to assess the possible risks and benefits of the candidate drugs or treatments. Clinical trials are conducted in a secured and regulated manner in order to ensure that the data collected is accurate and reliable.

In this section, we will be discussing the different types of clinical trials and their importance in the development of new therapies.

Types of Clinical Trials

Clinical trials are studies conducted to evaluate the safety and effectiveness of drugs, medical devices, and other treatments. Clinical trials are used to discover better ways to prevent, detect, diagnose, or treat various diseases and conditions. Since clinical trials are designed to evaluate new therapies or treatments in humans, it is essential that they are carefully planned and monitored in order to minimize the risks factors for participants.

Depending on the type of research question being studied, there are four commonly used types of clinical trials: interventional (also known as therapeutic), observational, mechanism-based (or translational) studies, and preventive studies. All four types of clinical trial fall under the larger umbrella of clinical research.

Interventional clinical trials involve trialling a new pharmacologic or non-pharmacologic therapy on a group of volunteers; including but not limited to medications (drugs), medical devices such as pacemakers or prostheses, procedures such as surgeries and rehabilitation regimens such as physical therapy. Volunteers for these types of trial must meet specific entry criteria established by researchers in order for their data to be used in comparison to a control group which could involve either an existing therapy or no intervention.

Observational clinical research is usually conducted with patients who have already been diagnosed with a disorder or disease; volunteers participating in these types of study can continue with their daily lives without any mandated interventions from researchers. The purpose is usually to evaluate observed behaviours over time between non-intervened patients compared against those receiving standard care therapy along with tracking outcomes through surveys or tests at regular intervals throughout the study period.

Mechanism-based (translational) studies aim at improving understanding about how certain drugs work when administered into a living system; using laboratory animals as study samples instead of humans helps researchers collect real time data about drug effects on physiological functions through tests measuring metabolic activity within cells as well as other biomarkers observing reactions associated with treatments under controlled environments more closely without risking human life until they reach satisfactory levels before beginning Phase I human testing trials where volunteers will receive intervening therapies during monitoring under strict observation protocols again requiring entry criteria that must be fulfilled by study participants in order for their results to be included into reviewable data sets collected during these particular types of clinical trials.

Preventive Clinical Trials take on aspects from both Observational Studies & Interventional Trials combined wherein healthy individuals receive some kind premeditated activities like dietary supplements or vaccines who already show zero signs or symptoms which may aid towards prevention towards something like cancer unlike Interventional Trials where pharmacological therapies like drugs pose varying degrees of risk factors when administered compared against control groups (placebo) which all potential candidates should consider going through proper consultation before deciding whether one wants participate within certain forms each above mentioned clinical trial either directly volunteering within randomized double blind agreements orchestrated now & then worldwide involving healthcare providers plus regulatory agencies involved operating healthcare institutions where these sorts initiatives may occur at times.

Benefits of Clinical Trials

Clinical trials are an important part of the research process for new medications and treatments. They help researchers determine not only the effectiveness of a particular treatment or medication, but also their safety and side-effects. Trials provide an opportunity to study new treatments under tightly controlled conditions and can often speed up the development process by helping to identify potential problem areas early on.

The primary benefit associated with clinical trials is the potential to improve medical care by developing treatments that are more effective impact more lives at a faster rate than traditional methods. By participating in one of these studies, participants have access to cutting-edge medical care that may offer better outcomes than what is currently available. Additionally, conducting clinical trials helps scientists develop evidence-based findings which can be used to inform public health decisions, policies and strategies aimed at improving patient outcomes.

Clinical trials help ensure that drugs or therapies are as safe for patients as possible since all studies must adhere to strict procedures in order to reduce any potential risks or biases. All research is also carefully monitored by independent review boards who assess the safety and ethical considerations of the trial before it can commence. Furthermore, researchers usually cover any costs associated with taking part in a study so participants are not required to bear any financial burden during the trial process.

Finally, taking part in a clinical trial can give participants access to helpful resources such as specialist care from leading providers, support from research staff and ongoing follow-up after the trial has completed which is invaluable for identifying long term impacts of treatments being tested.

Regulatory Requirements

Clinical evaluation is an important part of the medical device regulatory process. It is a key component of the evaluation of a device’s safety, effectiveness, and quality prior to market clearance or approval.

Clinical evaluation must be conducted in order to meet the regulatory requirements, and is essential for any medical device manufacturer.

This section will discuss the regulatory requirements for clinical evaluation.

International Regulatory Standards

When an medical device is employed in a clinical setting, its safety and efficacy must be evaluated to international standards. These standards vary regionally, however many countries have adopted the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), both established by the European Commission in order to ensure consistent regulations across member states.

The regulatory process for a new medical device is rigorous and ongoing as healthcare providers, manufacturers, and regulators work together to ensure the safety of patients utilizing these systems. The regulatory requirements start with an initial evaluation conducted by the researching institution or manufacturer under Good Laboratory Practice (GLP) rules set out by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This includes pre-clinical data collection, performance evaluations, validation studies, along with clarifying any potential risks associated with using the device.

Once satisfactory data has been collected from testing of prototypes or animal studies it can then be submitted to regulators in various markets through a mutual recognition agreement (MRA) between ICH member countries or via national procedures where appropriate. The conclusion from this evaluation will define whether safety and efficacy criteria are met allowing the progress towards a successful clinical trial or releasing the product into commercial market availability.

Throughout their life-span all medical devices must remain compliant with local regulations to guarantee patient safety. An approved product may need to carry out additional tests in consideration of changes such as design modifications due to feedback from clinicians as part of ongoing post-market surveillance activities via further clinical evaluations if warranted by changes made throughout its life-cycle within its development roadmap.

National Regulatory Requirements

The regulatory requirements to assess the safety of a medical device may vary depending on the country where it is going to be distributed. In countries with more stringent requirements, such as the U.S., Canada and the European Union, a clinical evaluation must be conducted to ensure that the device is safe and effective.

The clinical evaluation should be based on a systematic review and analysis of all available scientific data related to the device, including published data, post-market surveillance data from similar devices, bench-top testing and laboratory studies. It should also include references to relevant global consensus standards, as well as peer reviewed medical literature related to medical devices in general or state-of-the art technology review articles. The evaluation should also include user feedback from any studies or surveys involving real users of the device or similar products.

Clinical evaluations are highly regulated in most jurisdictions, so all regulatory agencies responsible for overseeing medical devices must obtain evidence that demonstrate adequate safety and performance before approving it for sale or distribution within their respective jurisdictions. The requirements include providing accurate product labelling information such as manufacturer contact information and an up-to date product description; providing notice of adverse event reports; conducting post market surveillance; providing periodic updates on compliance with applicable standards; documenting customer complaints regarding defective products; initiating corrective action when necessary; insuring all personnel who service/repair products have sufficient training; supplying stable power supply sources etc…

In-house manufacture of medical devices in Great Britain

This guidance is only relevant for healthcare institutions in Great Britain (England, Wales and Scotland). Information on the healthcare institution exemption applicable in Northern Ireland.

In-house manufacture refers to medical devices that are made in a healthcare establishment to be used for patients within that establishment.

A healthcare establishment is a body that provides care for patients and promotes public health (eg an NHS hospital).

You need to see separate guidance if you are manufacturing in vitro diagnostic (IVD) medical devices.

This guidance doesn’t cover independent dental practices that manufacture their own appliances.

This guidance outlines the minimum requirements that healthcare institutions must meet when performing in-house manufacture of medical devices. Manufacturers can choose to implement more stringent requirements (such as those outlined in the guidance document published for Northern Ireland) as long as the minimum requirements below are met.

You need to follow the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for certain activities relating to the in-house manufacture of medical devices. Some activities fall outside the scope of the regulations.

The UK MDR 2002 specifies that the exemption is only applicable to in vitro diagnostic medical devices (IVDs). Although not specifically stated, this guidance within the Regulations applies to both IVDs and general medical devices, and the in-house manufacturing exemption can apply to all medical devices assuming the below guidance is followed.

You should consider if:

  • the product is defined as a medical device or IVD
  • the intended purpose has been finalised or if it’s too early in the development stages to know
  • the establishment that makes or develops the particular device is defined as a manufacturer in line with the UK MDR 2002
  • the device is being placed on the market in line with the UK MDR 2002

These regulations don’t apply if your device is only being used for patients within the institute it was made, even if the product is made in one part of a healthcare establishment. For example, if it is made in an NHS trust laboratory and moved to another part of the hospital, as this means you are not placing it on the market.

They also don’t apply for those who put together or adapt existing devices for their intended purpose, for example a surgeon assembling an orthopaedic implant.

Devices transferred between hospitals

A transfer refers to a sale, loan, hire, lease, gift, or any other type of legal transfer. You should follow the regulations if you’re a healthcare establishment and you manufacture medical devices with the intention of transferring them to another establishment.

As this means you are a manufacturer, you must ensure the medical device complies with the conformity and UKCA marking procedures.

The UK MDR 2002 may apply for joint ventures between multiple establishments, even if there is a third establishment created to place the device on the market.

The regulations don’t apply if your institution has a specialist research and development laboratory that has been commissioned by another institution. This would usually be to manufacture a product for specific clinical or research purposes, which are not commercial objectives.

Sterilisation of devices such as surgical instruments is also not covered by the regulations as long as there is no change of ownership or new procedure pack needed.

Clinical investigations

You must notify the MHRA before you carry out a clinical investigation of a medical device if you are manufacturing it within your healthcare establishment and are selling it for profit.

Contact the MHRA

Please direct any queries to [email protected]

Medical devices: how to comply with the legal requirements in Great Britain


This guidance outlines the steps you need to follow before your product can be placed on the Great Britain market with a UKCA mark.

This guidance is specific to the provisions in Great Britain (England, Wales and Scotland). For information on how to comply with the legal requirements in Northern Ireland, please see our guidance on Northern Ireland.

Definition of a medical device

You need to decide if your product is a medical device before you go through the compliance process.

According to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002), a medical device is described as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
  • investigation, replacement or modification of the anatomy or of a physiological process, or
  • control of conception

A medical device does not achieve its main intended action by pharmacological, immunological or metabolic means although it can be assisted by these.

A medical device includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device.

If you are manufacturing a medical device you must follow the specific Part for your type of product as it sets out the essential requirements the product must meet in the interest of patient safety. See more information on what a medical device is in the UK MDR 2002.

See the guidance on borderline products if you are unsure whether your product is a medicine or a medical device or if it overlaps.

Medical device types and their associated Part

The 3 main types of medical devices and their associated Part in the UK MDR 2002 are:

  • general medical devices: Part II of the UK MDR 2002
  • active implantable medical devices: Part III of the UK MDR 2002
  • in vitro diagnostic medical devices (IVDs): Part IV of the UK MDR 2002

You must meet the requirements in the relevant Part before your device can be placed in the market.


Active implantable medical devices

These types of devices are powered implants or partial implants that are left in the human body. Examples of active implantable medical devices include:

  • implantable cardiac pacemakers
  • implantable defibrillators
  • leads, electrodes, adaptors for the above
  • implantable nerve stimulators
  • bladder stimulators
  • sphincter stimulators
  • diaphragm stimulators
  • cochlear implants
  • implantable active drug administration device
  • catheters, sensors for item above
  • Implantable active monitoring devices
  • programmers, software, transmitters

Active implantable devices fall within the highest risk category in the classification system for medical devices.

In vitro diagnostic devices

This type of medical device is usually a:

  • reagent
  • reagent product
  • calibrator
  • control material, kit, instrument, apparatus
  • equipment or system intended for use in vitro to examine specimens including blood and tissue donations from the human body

Other examples of in vitro devices are blood grouping reagents, pregnancy test kits and Hepatitis B test kits. See further guidance on the legislation relating to in vitro diagnostic devices for further information.

All manufacturers of IVDs must register their medical device with the MHRA..

General medical devices

These types of devices usually relate to most other medical devices such as:

  • first aid bandages
  • hip prostheses
  • X-ray equipment
  • ECG monitors
  • heart valves
  • dental materials
  • spectacles
  • depressors

If you are manufacturing a medical device, you must follow these guidelines alongside the relevant Part of the UK MDR 2002.

These regulations fall under the Consumer Protection Act 1987 and ensure medical devices meet the requirements so that they are acceptably safe to use and suitable for their intended purpose.

The route is different for custom made devices. See the guidance on custom made devices for more information.

Classification of medical devices

Medical devices are given a classification depending on the level of risk associated with them, for example the strictest control is for products with the highest risk.

General medical devices and active implantable devices

When you have established your product is a general medical device, you need to decide which class your device falls under. The categories are:

  • Class I – generally regarded as low risk
  • Class IIa – generally regarded as medium risk
  • Class IIb – generally regarded as medium risk
  • Class III – generally regarded as high risk

How a medical device is classified will depend on factors including the intended purpose of the device, how long it’s intended to be in use for and if the device:

  • is invasive/surgically invasive
  • is implantable or active
  • contains a substance, which in its own right is considered to be a medicinal substance

Accessories to medical devices are classified separately to the device, excluding accessories to active implantable devices. See guidance on how to establish which classification your product falls under.

All active implantable medical devices and their accessories fall under the highest risk category (Class III).

In vitro diagnostic medical devices (IVDs)

In vitro diagnostic medical devices are categorised differently into 4 main groups, which are devices:

  • considered as general IVD medical devices
  • within the classifications stated in Part IV of the UK MDR 2002, Annex II List A (as modified by Part III of Schedule 2A to the UK MDR 2002)
  • within the classifications stated in Part IV of the UK MDR 2002, Annex II List B (as modified by Part III of Schedule 2A to the UK MDR 2002)
  • for ‘self-test’ intended to be used by a person at home

Conformity assessment and UKCA marking

Once you have established how your device should be classified or categorised, you will need to follow the conformity assessment route to show that it has met the requirements in the UK MDR 2002. For more information on marking of medical devices, see our guidance on how medical devices are regulated.

Assessment route for general medical devices and active implantable devices

If you have decided that your medical device falls into Class II, IIb or III, or is a Class I device that is sterile or has a measurement function, you need to contact a UK Approved Body that can carry out a conformity assessment for the specific classification.

A UK Approved Body ensures manufacturers comply with the regulations including reviewing clinical and scientific data, manufacturing processes and the quality management system. If they comply the UK Approved body will issue a UKCA certificate, which manufacturers can place on their device to show that it has passed the conformity assessment. See more information on the role of a UK Approved Body and the list of UK Approved Bodies in Great Britain.

The conformity assessment route is different for devices being placed on the market in Northern Ireland. For more information please see our guidance.

Class I medical devices do not need to go through a conformity assessment with a UK Approved Body if they are non-sterile and don’t have a measuring function as they are generally low risk.

You must register all medical devices on the Great Britain market with the MHRA.

Assessment route for IVDs

You must register all IVDs with the MHRA. If your product is listed in Part IV of the UK MDR 2002, Annex II (as modified by Part III of Schedule 2A to the UK MDR 2002) or is a self-test device, you will need to contact a UK Approved Body.

UK Approved Bodies will need to release in vitro products with the highest risk on a batch-by-batch basis. They will need to ensure that the product meets the relevant requirements before certifying it. You can then place the UKCA mark on your product to demonstrate compliance and it will be ready to place in the Great Britain market.

See the different routes to conformity for IVDs in our guidance.

The conformity route is different for devices manufactured in healthcare establishments, see the guidance on in-house manufacturer of devices for more information.

The conformity assessment route is different for devices being placed on the market in Northern Ireland. For more information please see our guidance.

Clinical data and clinical investigations

Manufacturers must hold clinical data to support claims made for all types of medical devices. This may be based on clinical investigations and in some cases published literature, where you can demonstrate equivalence. See more information on clinical evaluations.

You must inform the MHRA if you are planning to conduct a clinical investigation at least 60 days before starting your investigation. This does not currently apply to IVDs, although you must notify the MHRA about IVDs for performance evaluations.

Post-market monitoring and surveillance

Once a medical device has been placed on the Great Britain market, the manufacturer is responsible for monitoring the product and reporting serious adverse incidents to the MHRA. See guidance on reporting adverse incidents for information on how to do this. This ensures the device is acceptably safe to use for as long as it is in use.

See how to report a non-compliant medical device if you notice any issue with a medical device placed on the Great Britain market.