How should the EU Medical Device Regulation (EU MDR) be interpreted when it comes to medical device postmarket surveillance?

The panelists participating in the Oct. 28 virtual panel discussion, “Changing Medical Device Regulations,” addressed medical device postmarket surveillance under the EU MDR. Redica Systems GMP Medical Device Expert Mark Agostino and Regulatory Mark Founder Alison Sathe answered questions submitted by attendees, while Redica Systems Senior GMP Quality Expert Jerry Chapman moderated the panel.

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Below is the second in a multipart series covering this webinar. Part I looked at the impact of the EU MDR on a company’s quality management system (QMS).

Postmarket Surveillance: A Complex Web

Jerry Chapman

Chapman: Postmarket surveillance for medical devices is critical. How does the EU MDR address postmarket surveillance?

Mark Agostino

Agostino: I think one of the biggest changes in regard to postmarket surveillance is just the complexity. You now have the manufacturer, Notified Bodies, competent authorities, authorized representatives, importers, distributors—they are all intertwined.

From a postmarket perspective, there are two things you need to know. First, residing in the European Union or outside the European Union is going to impact your reporting structure and requirements. Due to the complexity, you should be aware that you might receive multiple notifications when product and quality issues arise. Your importer might send you a notification and then your distributor might notify you of the same quality issue.

Second, understand how that is going to impact in terms of notifications to your authorized representative, Notified Bodies, and competent authorities. It makes everyone aware of when these issues arise, especially if it is something of a serious adverse event or something that is of significant concern.

You also have ISO 14971:2019 Medical devices — Application of risk management to medical devices. That basically drives up the level of accountability within an organization. Now senior levels need to sign off on risk management reports. This all fills into all of the postmarket surveillance activities you need to track and monitor. Getting into risk management, labeling, manufacturing, your clinical evaluation reports, your summary of safety, and clinical performance.

Alison Sathe

Sathe: There is a more prescriptive approach now to kind of postmarket surveillance in general.  So, when we are getting reports in, what does that require us to do? Who gets notified? How does that notification occur? What does your vigilance reporting look like? All of those things obviously need to be documented.

There is that proactive approach. It is like a web, everything is connected to each other—risk management, suppliers, R&D, etc. All of those kinds of aspects point to each other. With the postmarket piece, that is a lot of the improvements that we are seeing folks in industry make, i.e., strengthening that piece of what does the web look like?

That kind of infrastructure piece is so important—making sure that those connections are really clear because, of course, what the regulators are looking for is making sure you understand these requirements and you have proceduralized them to make sure you are doing the right activities. Also, your records show that you are following your procedures appropriately.

[Editor’s Note: In the video clip below, the panelists discussed the importance of taking a risk management approach to postmarket surveillance under EU MDR.]

EU MDR and Clinical Studies

Chapman: How will these changes impact clinical studies in the European Union?

Agostino: I think we have touched on various elements thereof. For manufacturers, they have to adopt a sort of a total product lifecycle (TPLC) approach. The clinical studies are obviously required for an initial regulatory submission, but also in developing postmarket surveillance and postmarket clinical follow-up plans along with postmarket clinical follow-up studies.

It is all about generating that appropriate level of clinical evidence to support your product, and to address any issues that you may have seen basically from your product existing in that marketplace. So again, it is all part of that holistic type of approach that needs to be adopted. 

Another point is around the equivalence. There’s a Medical Device Coordination Group guidance on equivalence. And I think as a manufacturer, you have your pressures from the business and timeline to bring your product to market. And equivalence is something that is definitely looked at not only within the European Union but also by other regulatory authorities worldwide. It is an important document to justify your design validation studies that the device under test is representative of your commercial products.

Sathe: I am so glad you mentioned equivalence, Mark, because that was right where I was going. We always used to kind of rely on that. So if you have some product and there is a competitive product on the market, you could previously use that to kind of say, ‘Okay, here is the risk profile, the clinical benefit,’ and all of those things and rely on that equivalence.

And of course, now the big change is you need to have access to that technical file. And the detail of that equivalence assessment is major, right? It has to be very, very close in terms of the technology, the biocompatibility, the clinical effect—all of those things. And there is that guidance there. But that’s one of those where I’m very interested to see the reactions of notified bodies to some of those equivalence determinations, right, and how broadly or narrowly is that going to be interpreted? Because, of course, the guidance can also be interpreted narrowly or broadly.

And so having that justification in place, and if you are planning on using an equivalence determination, just understanding how different that is from how it used to be is so important.

EU MDR and the Supply Chain

Chapman: What major aspects of the EU MDR should vendors and supplier companies be aware of with regard to manufacturing? 

Agostino: It strikes me from a sort of a supplier quality standpoint. The regulations and ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purpose, Section 7.4, as well as 21 CFR 820.50 for the United States—these sort of identify the level of requirements for supplier quality. But it really also comes down to your risk determination. As you talk about your supplier’s suppliers, how is the impact on final design evaluated through your risk management processes?

That is something that is up to the organization to sort of assess. And if it is something that dictates a level of adherence and oversight, that is going to be required from a supplier quality standpoint in order to appropriately address that. That is sort of the way I just look at that. Alison, what are your thoughts?

Sathe: Absolutely. And I think it all comes back to that ISO 14971 risk-based approach covering all of the activities that you are doing from design, development, manufacture, etc. It comes down to risk. Clearly, for some products, i.e., more sophisticated or complex products, there are more sophisticated or complex systems that might be needed to support them.

Making sure that your supplier qualification and management process is based on risk is the way to go because you do have some low-risk components or parts or supplies or processes that you do not have to have as much oversight over. And you really want to focus your time and attention on those that are essential performance types.

That goes to not just the components in your device, but for your process. And absolutely, if you have equipment that is being used in your process and production that you are outsourcing and is essential, all of that needs to be viewed through that risk-based framework

[Editor’s Note: Part III examines intended purpose for products marketed in the European Union that already have U.S. FDA 510(k) clearance.]

[Related: You can download the webinar, “Changing Medical Device Regulations,” in its entirety here.]

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