The new European Union Medical Device Regulation (EU MDR) comes with a steep path to compliance. But it also comes with a more effective path to achieving a common goal – ‘ A safer healthcare ecosystem’. We have classified the Changes, Challenges and, Contributions by consolidating a list for each ‘C’ from experts within the industry.
Identifying the Changes
The new EU MDR calls for stricter rules, more transparency and increased availability of quality data. We have identified the main changes that are relevant to all medical device manufacturers.
- Product scope expansion
- Identification of a “qualified person”
- Implementing an identity that is unique to the device (Unique Device Identification Number)
- Rigorous post-market oversight
- Reclassifying devices according to risk, contact duration and, invasiveness
- More rigorous clinical evidence for class III and implantable medical devices
- Systematic clinical evaluation of Class IIa and Class IIb medical devices
- No “grandfathering” provisions
Early identification of the changes and their applicability can enable you to benefit from these changes. The identified list of changes is explained in a more in-depth article by TÜV SÜD in the link below.
Now that we have identified the Changes the next section will highlight the challenges that medical device manufacturers will face with these new requirements.
Coping with the Challenges
Change in requirements will require manufacturers to adjust the mindset and workflow within the organisation. This will affect the overall product lifecycle, as well as budgets, and time to market if not complied to.
- There will be an acute demand for clinical experts and additional education
- New skills for clinical experts supporting the medical device manufacturers
- Trouble in collecting and managing sufficient Clinical Evidence
- Updating the clinical evaluation report
- The equivalence conundrum
- External PMS data and the MAUDE database
Peter Kruse, MD, Ph.D. – is an independent pharmaceutical and medical device consultant and he has written a series of articles on the EU MDR on LinkedIn which cover the new challenges that will arise. Take a look at some of his articles by following the link below.
Consequently, addressing these Challenges will enable further development and innovations which will contribute to a safer healthcare ecosystem.
Unveiling the benefits of Contributions
One of the main contributions brought about by the EU MDR is ‘The Eudamed database’ which will allow for information exchange on medical devices’ market surveillance, clinical investigation information, and safety and clinical performance.
Medical devices in the EU will also be tracked online with a Unique Device Identification (UDI) number, making it easier to glean information on individual products. These UDI numbers will be located in Eudamed.
Conclusively, the Contributions made by the EU MDR like the EUDAMED database help us work toward a safer future with trust, transparency and, traceability.
The 3 c’s: Changes, Challenges and, Contributions as a result of the new EU MDR
In Conclusion, The Changes are targeted toward the efficacy and traceability of clinical evidence while the Challenges are targeted toward skilled experts and clinical evaluation. The challenges can be addressed through cooperation with skilled medical experts when conducting clinical investigations. Furthermore, there needs to be an implementation of provisions for sufficient clinical evidence collection and validation. With the changes and challenges, the EU MDR also brings Contributions. The main Contribution is the EUDAMED database which helps us work toward a safer future with trust, transparency and, traceability.
When addressing the EU MDR, one of the main issues is compliance. Previously, we presented our 3 pieces of advice on how to comply with the new EU MDR – take a look and learn how you can take the first steps toward compliance.
Visit SMART-TRIAL to see how we can assist you on your path to compliance.