While the EU Medical Device Regulation became effective earlier this year, questions remain about its interpretation. 

Recently, the Redica Systems virtual panel, “Changing Medical Device Regulations,” featured two industry experts providing their insights on the EU MDR and other medical device regulations: Redica Systems GMP Medical Device Expert Mark Agostino and Regulatory Mark Founder Alison Sathe. Redica Systems Senior GMP Quality Expert Jerry Chapman moderated the panel.

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Below is the first portion of a Q&A transcript from the virtual panel.

EU MDR versus MDD

Jerry Chapman

Chapman: What are the major differences between EU Medical Device Regulation (EU MDR) and its predecessor, the EU Medical Device Directive (MDD)?

Alison Sathe

Sathe: Straight away the EU MDR covers things like sterilization and cleaning products for medical devices, devices without an intended medical purpose, like aesthetic devices that were not previously covered under the MDD, and incorporates the active implantable devices as well.

And when it comes to the classification, or definition, of medical devices, some more nuance around certain parameters. Things like substances and software. You have more details surrounding those types of products. And then, of course, there is the further stratification of Class 1 products. So then you’ve got the subgroups of Class 1S, Class 1R, and Class 1M devices as well. All across the board, we are kind of seeing more detail and more rigor in terms of the documentation that you need to provide to support your marketing applications as well as your quality management system (QMS).

Mark Agostino

Agostino: In addition to what Alison talked about, I think a couple of additional areas note is that the person responsible for regulatory compliance is not stipulated under the EU MDR. That is a big change compared to the EU MDD—having someone accountable for providing oversight over your QMS. Having that level of oversight to identify issues, gets into the premise of the EU MDR and why it was created, which is to sort of hold manufacturers accountable including senior management to issues as they arise to a product out there in the marketplace.

Another change from the MDD is the function of Notified Bodies and the legal responsibility of notified bodies. Under MDD, Notified Bodies were able to provide sort of consulting services to manufacturers and help them sort of understand that pathway to get their product to the market. Well, that is really no longer. And I think that is also contributing to the angst and challenges for manufacturers to navigate the pathway of MDR…not having that ability to consult on a regular basis for your Notified Bodies during the various elements of the regulation.

EU MDR Requirements for QMS

Chapman: What do you consider some of the challenges of the EU MDR when it comes to the QMS?

Agostino: For me, one of the challenges is device classification as Alison mentioned. In regards to your QMS, you now have to account for that risk and that change in risk for your devices.

Also, there are still elements that have not been fully fleshed out. Expert panels still need to be created and implemented. The intent of these expert panels is to provide a level of standardization for various device types and to help establish a level of consistency in interpreting the EU MDR. Additionally, there are competent authorities who actually do not think EU MDR has gone far enough, which means that QMS are going to need to potentially account for whatever changes that these authorities come up with over the coming years. Manufacturers will also have to understand their economic operators and related QMS requirements. 

[Editor’s Note: For more on the EU MDR and economic operators, read Mark Agostino’s article, “EU MDR and Economic Operators for Medical Devices.”]

Sathe: I fully agree with this. And I think to your point about the breadth of the EU MDR, one of the things I see folks do when they’re looking to start their pathway is jump into the technical documentation. I actually caution, make that Step 2. People see the EU MD and they say, “I am going to just start with my General Safety and Performance Requirements (GSPRs), and I am going to go from there.”

That is great, you need to do that. Your technical documentation will need to be updated. But I think starting with that QMS piece is really important because you need to make sure that you have that infrastructure in place for not just updating your technical file, but the ongoing activities that are required.

It is really a paradigm shift for a lot of folks in that there is just more detail required both in the technical documentation premarket, but throughout the total product lifecycle (TPLC). If you do start with your QMS, it actually makes that second piece [the technical documentation] a lot easier because then you have the form, the format, the structure that is going to support everything going into your technical file. 

[Editor’s Note: For more on EU MDR challenges, check out the video clip below.]

Chapman: What are some of the pitfalls and the new paradigms companies should look out for? Such as things like transition timing, staffing and resource allocation, and the regulatory, quality, and clinical areas.

Sathe: I think that goes back to that infrastructure piece, it is not just going to be one technical person that is going to be able to handle all of your updates. It is not just a quality person. We are seeing more and more involvement from all of the various aspects of the TPLC.

When you are looking at things like risk management, particularly in combination products, you need to really develop robust risk management with the TPLC that includes all of the various voices—your clinician or your chief medical officer, your engineers, your quality staff, your regulatory staff. All of those folks are going to be required for review and approval of all of the various documentation that is going to go in to fulfill those GSPRs and your postmarket requirements.

Agostino: To further add on to that, just to me, I think some of the challenges that manufacturers are experiencing are due to varying interpretations of the regulations by Notified Bodies. I think that is also part of the challenge, understanding from a resource and timeline standpoint how to get your product to market. From people that I have talked to and who deal with this here in Europe, I think they want that level of consistency, going from one Notified Body to the other. 

This transcript has been lightly edited for clarity.

[Editor’s Note: Part II of this series looks at postmarket surveillance requirements.]

[Related: The webinar recording is now available for download here.]

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