Helping Clients With Their Transformation From European MDD To MDR
“Europe’s Medical Devices Regulation” (2017/745) was mandated on May 2021. Through this regulation, organisations marketing their medical devices in the regions of the European Union must maintain the CE Mark certification. It indicates that the devices are aligned with the MDR compliance regardless of the obstacles, such as work backlogs and shortage of Notified Body staff.
5AI Consulting helps clients with their European MDD to MDR transition. With its senior regulatory consultants, it becomes easier to identify the company’s best EU MDR compliance strategy based on the product range, markets to serve, certification cycle, and the Notified Body.
Changes in MDR 2017/745 for Medical Device Manufacturers
Compared to the MDD, the latest MDR 2017/745 changes introduced a lifecycle approach for ongoing CE Marking compliance. Further, the conformity assessment processes are more complicated, and equivalence is more rigorously interpreted. Additionally, clinical data and CER (Clinical Evaluation Report) will face heavy scrutiny and other recurring updates. The manufacturers must fulfil increased post-market surveillance requirements. Also, the manufacturers must perform Post-Market Clinical Follow-up (PMCF) studies, along with the Period Safety Update Reports for Class IIa devices.
EU MDD to MDR 2017/745 – Transition Strategy Plan and Gap Analysis
Transitioning to the MDR might indeed be overwhelming, and most companies don’t know how to go through with it. 5AI provides you with a chance to assess your current level of compliance. With a thorough gap analysis, we help manufacturers generate a task list for updating their procedures and documentation to improve the overall prospect of medical devices.
The next step is to examine your present clinical data through the CER to ensure that your company is with the MEDDEV 2.7/1 rev 4. Please note that the Notified Bodies already seek a higher quality for all kinds of clinical evidence and conform with requirements for clinical data. This can be a long process, so it’s best to get started as soon as possible.
We Help You Get Started with the MDR Gap Analysis
5AI Consultants can perform a systematic and independent gap analysis of your technical documentation processes and ensure that you understand the steps required for Medical Device Regulation. Our well-detailed MDR gap analysis is executed by our senior consultants, who will also review the following elements:
- CE Marking Technical File or Design Dossier
- Risk Management File Review
- Economic Operators Agreements Review (along with the European Authorized Representative agreement)
- Clinical Evaluation Report(s)
- Post-Market Surveillance (procedures, strategies, effectiveness, PMCF, and results)
- Current Device Class and Product Families
- Supply and Distribution Chain Management Procedures
- Relations with Your Current Notified Body
- Product Life Cycle Plan
These consultants will prepare a detailed report mentioning deficiencies and recommendations for resolving them.
Market medical devices in the EU marketplace efficiently with 5AI Consulting. Call us now!
5AI Consultants has been helping medical device manufacturers with these regulations since [enter date]. Let us help you thrive in this exciting industry. Reach out to us today!