Europe – Is Your Testing Program Ready for the EU MDRs?

The new EU regulations will require much more documentation and perhaps some new evaluations from medical device manufacturers. An expert explains how to perform a gap analysis and begin preparing now for May 2020.

The European Union’s new Medical Device Regulations (EU MDR) will require that all medical devices – even legacy products – have updated clinical data and technical documentation to support device safety and conformity with the new regulatory standards, Sandi Schaible tells MD+DI. Schaible is the senior director of analytical chemistry at WuXi AppTec, where she specializes in extractables and leachables studies. She is a U.S. delegate and international delegate for ISO 10993 part 18 in chemical characterization. She is also a U.S. delegate for ISO 10993 part 13 and the particulates committee.

MD+DI asked Schaible a few questions about what medical device manufacturers can expect with the new requirements and what steps they can take now to prepare.

What do medical device manufacturers need to know about how the EU MDR will change requirements for medical device testing and data documentation, both pre and post CE marking?

Schaible: MDR requires that you provide robust data to demonstrate the performance and safety of your device. Regulators will be looking to see that the device has been challenged under harsh conditions and that all chemical, toxicological, and biocompatibility information has been accounted for. The new standards will place more emphasis on the importance of chemistry. Be sure that no unknown substances surface in your chemistry reports, and in the case that unknowns do appear, you should be prepared to repeat your testing or provide supplemental information.

If your device is a Class I reusable device (Class Ir), a notified body must review the device’s technical file to confirm compliance before you can obtain a new CE mark. The technical file should prove the safety and efficacy of the cleaning, disinfection, and sterilization processes outlined in the device’s Instructions for Use (IFUs). While OEMs have been permitted to self-designate their devices as Class Ir in the past, this will not be the case under MDR. Additionally, Class Ir devices cannot be grandfathered in or receive extensions, so prioritizing these devices is prudent…