Understanding the EU MDR

In a recent MD+DI webinar called, “Understanding the EU MDR”, which was sponsored by Accumold, Nelson Laboratories, and Oliver Healthcare Packaging, Dr. Bassil Akra, CEO of Akra Team GmbH, gave insight on the European Medical Device Regulation (MDR), its ongoing challenges, and its changes compared to the Medical Device Directive (MDD).

At the end of the hour-long presentation, Akra answered questions from the audience. In his detailed replies, he gave additional insight into the new regulations as a whole and its intricacies.

See one question answered by Akra below:

Can you give a few examples of the major differences between MDD and MDR?

Akra: The major difference between the MDD and MDR is the fact that MDD is a directive, which means it needs to be translated into regional local laws, whereas an MDR regulation is published immediately in the various languages of the member states and is applicable as is.

What is the difference regarding the content?

The main differences are related to the essential requirements which we had under the directive. We had essential direct requirements which are now translated to general safety and performance requirements. These are now more detailed and set new expectations on, for example, cybersecurity, which weren't a discussion point in the 1990s, and nanomaterial expectations, also which weren't a discussion point on the previous directive.

This is based on the experiences that were gained over the years. The additional differences between MDD and MDR are related to the amount and level of clinical data that you need to get the device approved in the EU, and limitations related to class III and implantable devices. The European system is setting higher expectations on having more clinical studies according to good clinical practice. Additional expectations include regular post-market surveillance obligations which we didn't have under the previous directive.

You are required as a manufacturer to have a post-market surveillance plan, post-market clinical follow-up plan — which can in some cases be justified as not relevant, a regulation push on having plans and reports, and expectations on how often you need to update them. In addition, the MDR has transparency guidelines for class III and implantable devices which expects manufacturers to create an SSCP and to update that SSCP when relevant, annually. This is an additional push on manufacturers on time and resources. Manufacturers must also have that SSCP translated into various languages which was not in the old directive. Additionally, the IDI and UTI requirements are connected with the MDR.

Now, on to the MDR's new classification rules. These rules mean a lot of devices which were considered low risk in the past directive, such as self-declared class I devices, now move to a higher class. We also have devices which were class II A that are now class III, which impacts the conformity assessment and process with notified bodies because the European system differs between low risk and high risk devices.

To hear Akra’s other insightful replies to audience questions, as well as his detailed presentation on the MDR, click here to watch the full webinar on demand.