What are the implications of the EU Medical Device Regulation (EU MDR) when it comes to combination products? And what resources are available for companies when it comes to training?

These questions and more were addressed in the Oct. 28 Redica Systems webinar, “Changing Medical Device Regulations.” Experts Mark Agostino (Redica Systems) and Alison Sathe (Regulatory Mark) answered these questions while Jerry Chapman (Redica Systems) moderated the panel

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This is the fourth and final article in this series. Part I featured insights on quality management systems (QMS) requirements under EU MDR and Part II examined postmarket surveillance. Part III covered regulatory harmonization of EU MDR requirements.

The following transcript has been lightly edited for clarity.

EU MDR Requirements for Combination Products

Jerry Chapman

Chapman: For EU MDR postmarket surveillance and ISO 14971 Medical devices — Application of risk management to medical devices compliance, have you found any unique considerations or perspectives applicable to combination device manufacturers?

Mark Agostino

Agostino: Regarding combination device manufacturers, this means getting into Article 117 for drug-device combination products. The world has sort of switched a bit from the previous Medical Device Directive to the changes in EU MDR. Specifically, as it relates to the issue at hand, I think, in general, ISO 14971—it affects all devices across the board in the same way in terms of basically the requirements from doing a total lifecycle approach and driving that level of accountability to the senior levels of the organization. That will affect the device portion or the device constituent of a drug-device combination product in a similar way.

From your postmarket standpoint, that is all part of the changes that have been incorporated as part of EU MDR.

[Editor’s Note: For more on EU MDR Article 117 and its impact on drug-device combination products, read Mark Agostino’s article, “Navigating a Regulatory Path to Market Through EU MDR Article 117.”]

Alison Sathe

Sathe: Absolutely. And to augment that, from just a tactical approach for combination products, actually laying out in your risk management process the requirements for ISO 14971 and ICH Q9: Quality Risk Management…the drug constituent risk, the device constituent risk, and the overall product risk, I think laying that out in your risk management process can be really helpful. Whether that is in the form of a flowchart where you’re looking at the documentation that will be created throughout the process or your risk management plan.

All these tools can be really helpful for you at the beginning to make sure that you are addressing ISO 14971. And I think with combination product manufacturers, probably, that is becoming more of a factor. And I think a lot of people are sitting up and asking ‘how are we fulfilling some of these requirements?’”

EU MDR Education and Training

Chapman: How would you recommend educating or training your workforce on the EU MDR changes?

Sathe: This goes back to your quality system, i.e., having a good training procedure where you make sure that you are disseminating the right information to the right people at the right time, as that is a requirement. To make sure they are trained for the tests that they are required to do.

And so there are a lot of different options. There are a lot of materials just out there on the Web that are free. These are great resources for really kind of learning about this. But then when you now you have a responsible person in your organization that is looking at  EU MDR, how do you train the rest of the team in formalizing that piece that needs to be customized to what you are producing, e.g., the level of risk of your product, the complexity, the actual scope of what you are doing within your organization, as all of those things need to be determined on a case-by-case basis to make sure that the right individuals are getting trained at the right times. 

Agostino: Adding to that point, the British Standards Institution (BSI) puts out a lot of webinars on the topic.

As mentioned, there is a whole lot of free information out there. Since 2017, there has been a lot of information generated on EU MDR. It has been updated over time. But there is a lot of information available to at least get a basic understanding of each of the annexes as well as postmarket surveillance, clinical evaluation, etc. There is a lot of information that is out there to help become familiar with the requirements and expectations for the product that you are working on.

[Editor’s Note: The video below features an expanded discussion on EU MDR and training taken from the webinar.]

Small versus Large Companies and EU MDR

Chapman: There are companies that have opted not to transition. Can you both comment a little more on that and why some companies have opted to just not transition?

Sathe: I think Mark made such a good point earlier about predictability. There are a lot of unknowns, and the scope of EU MDR and the areas that it touches is enormous. At least in my experience, the smaller companies are the ones that are saying, ‘we are just going to pull product altogether.’ The larger companies that we work with, some of them are streamlining their product offerings. So they are saying, ‘okay, we are going to focus on these kinds of product offerings first and let the rest wait.’ 

Agostino: Exactly. For some of the mid-sized clients I deal with over here in the European Union it is a resource question. You have a pool of money and you have a pool of resources, and you are also trying to get a product to market. They balk at the enormity of basically what the EU MDR requires.

I think a lot of people are just scared in some sense at the beginning of the breadth of changes. But it is a big commitment. And as Alison mentions, when you are a larger organization, well, you have that flexibility. You already have a lot of the functions and the systems and the processes that have already been developed in place that you might only need to augment to a lesser degree to address the requirements of EU MDR.

When you are a smaller outfit and you are looking to get one or two products on the market to keep yourself going, you are making a hard decision. And going down the more well-understood path is what it really comes down to for some of these companies as to why they might go the U.S. route. 

[Related: To download and view the webinar, “Changing Medical Device Regulations” in its entirety, click here.]

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