Transition to New Legislation

The European Medical Device Regulation is a set of guidelines overseeing the production and distribution of medical devices throughout the countries in the European Union. So, a manufacturer looking to sell these products in the European marketplace must adhere to the policies placed by the MDR. Further, manufacturers must develop a suite of MDR-compliant regulatory systems, procedures, and documentation to monitor the performance and safety of the products.
Since the inception of the Medical Device Regulation (MDR – Regulation EU 2017/745) on 26th May 2017, manufacturers have been striving to gather and craft evidence of compliance with these medical devices. Please note that all devices on the marketplace must undergo the complete Conformity Assessment under the testament, latest by 24th May 2024.

Furthermore, manufacturers developing medical devices have shifted towards the new regulation. However, for those with legacy products, an in-depth understanding of the transition provisions is essential for determining strategic options and developing a roadmap tailored for different medical devices.

MDD to MDR Devices

Product Scope Expansion

The definition of devices and active implantable medical devices will follow the guidelines of MDR and will be expanded to include devices that aren’t used for medical purposes.

Identification of a Qualified Person

Please note that device manufacturers must identify at least one person within their organization who will be responsible for all layers of compliance as per the new regulation’s requirements.

Implementation of UDI

The MDR necessitates that manufacturers use Unique Device Identification (UDI) mechanisms. It is expected that this will increase the manufacturers’ and the authorities’ ability to trace specific devices through the supply chain procedures.

Reclassification of Devices Based on Contact Duration, Risk, and Invasiveness

Please note that the MDR instructs device manufacturers to review the updated classification rules and modify their technical documentation if needed. In addition, they must consider that class III and implantable devices will have better clinical requirements and scrutiny processes.

Clinical Evidence for Class III and Implantable Medical Devices

Another point to note is that manufacturers will have to conduct a clinical investigation if they fail to provide enough clinical evidence to support the claims made on the performance and safety of a dedicated device.

Clinical Evaluation of Class IIa and IIb Medical Devices

For this clinical evaluation, the manufacturer will have to prepare their clinical evaluation again by considering the new wording of the regulation with their equivalence approach. Only through this evaluation can the manufacturers justify not conducting a clinical investigation.

Post-Market Inaccuracy

The Notified Body has increased post-market surveillance authority.

Grandfathering Provisions are Not Allowed

It’s worth noting that under the MDR, all currently approved devices must be approved under the new guidelines.

Remediation Process

In order to help manufacturers comply with the new IVDR requirements, conformity, and classification routes by the GAP analysis, the following services are included in our remediation process:

  • IVDR technical file creation support
  • Presubmission files
  • Experimental design to gather data to remediate technical files
  • Statistical support
  • GAP assessment
  • QMS support
  • Post-market performance follow up

Other IVDR Services

Some of the other IVDR services include:

  • Notified Body support
  • PRRC | Person Responsible for Regulatory Compliance
  • Interim management
  • CE Certification Strategy
  • European Authorized Representative

IVDD to IVDR Services

Product Scope Expansion

IVD devices are covered under this regulation, and it will be significantly expanded further.

Reclassification of Devices

Risk classes will range from Class A for low-risk devices to Class D, which are highly risk-prone.

Identification of a Person Responsible for Regulatory Compliance

Manufacturers must note that they must identify at least one person from their company who will ensure that the devices comply with the requirements mentioned in the regulations.

Increased Notified Body Involvement

To comply with the risk classification scheme for the application of the IVDRs, a Notified Body should be aligned. It will be responsible for approving Class A devices.

Implementation of UDI

The regulation dictates the use of UDI mechanisms for all devices.

Requirements for Technical Documents

The regulations continue to increase the level of detailing of the content present in the technical documentation.

Greater Inspection of Notified Bodies

Please note that the competent reference laboratories and authorities must be involved during the conformity assessment procedures of the high-risk devices.

Grandfathering Provisions Are Not Allowed

Under the guidelines of IVDR, all approved in vitro diagnostic devices must be recertified as per the new requirements.

UKCA Marking – Everything You Need to Know

CE Marking can be applicable within Great Britain until 1st July 2024, while the UKCA Marking affixed to the product and accompanying documents, latest by 30th June 2024.
It was on January 2021 that the United Kingdom was separated from the European Union. During this time, the UK had to introduce UKCA Marking in lieu of CE Marking. The latter one was previously accepted.Major EU Legislation after the Introduction of UKCA covers:

  • Machinery Directive (MD)
  • Pressure Equipment Directive (PED)
  • Low Voltage Electrical Equipment Directive (LVD)
  • Restriction of Hazardous Substances (RoHS)
  • Electromagnetic Compatibility Directive (EMC)

Presently the UKCA Marking Legislation is working similarly to the EU CE Marking Legislation. For instance, the EU technical file, consisting of test reports for EMC, RoHS, and safety used for the CE mark can also be used for the UKCA mark.
Further, the mode of self-evaluated compliance of the system is similar. However, in the case of the EU-notified body, the new UKCA mark’s notified body must be used.
Some of the major elements of standard self-evaluated UKCA mark legislation include:

  • Modifying all documentation where the CE Marking was used, and change it with the UKCA Marking and the UKCA Declaration of Conformity.
  • Executing changes to the writing plate of the system and adding it to the UKCA Market.
  • Updating internal procedures to reflect UKCA marking requirements, including IMSes and QEOs.

Please note that UK-based consumers will not accept these new forms without the UKCA marking, and will be reflected in contractual sales agreements.

  • UKCA Mark

  • UK conformity assessment

  • Guidance for impacted directives for UKCA and related UK laws:

  • UKCA Designated standards

Post-Market Surveillance

  • Our consultants will guide device manufacturers in conducting the Post Market Surveillance.
  • We will develop risk profiles based on the Post Market Surveillance strategy for the medical device
  • We’ll also provide guidance documentation requirement to enable effective implementation of the Post Market Surveillance system.
  • The goal is to evaluate current PMS data and draw suitable conclusions to maximize compliance with the new regulations in target markets.
  • We will also deliver well-structured PMS data and acquire suitable conclusions to ensure compliance with the new regulations in relevant markets.
  • Our consultants will also craft and deliver PMS plan, procedures, and report templates
  • Vigilance reports in accordance with the local requirement with timely delivery.
  • We will also provide regulatory support for the review and compilation of the annual reports.
  • Our consultants will also deliver support for product recall, medical device reporting, and customer complaint handling, over country-specific regulations.
  • We will acquire PMCF requirements for PMS data and medical device registration, case and exposure management, and event follow-up.
  • 5AI Consulting will perform post-marketing literature surveillance, regulatory assessment, and diagnostic reporting.

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