Tackling the Most Burning EU MDR QuestionsTackling the Most Burning EU MDR Questions

Elisabethann Wright, Senior Counsel with Steptoe LLP, answers some of the most pressing questions about European Union Medical Device Regulation. The EU MDR replaced previous Medical Device Directive.

Omar Ford

January 23, 2025

4 Min Read

Late last year, Elisabethann Wright, Senior Counsel with Steptoe LLP, gave a presentation for a webinar titled “How Different Are the EU & FDA Medical Device Regulations,” which was sponsored by Nelson Labs and hosted by Informa. MD+DI’s Editor-in-Chief Omar Ford served as the moderator for the event.

During the presentation, Wright answered several questions from the audience regarding EU MDR. The following is a transcript of those questions and Wright’s answers.

How much, if any, will EU MDR change with FDA's decision to synchronize medical device manufacturing with the ISO 13485 standard for QMS?

Wright: This will definitely be an advantage. In my presentation, I discussed the potential to leverage clinical, technical, and biological data generated in the U.S. for assessment in the EU. One challenge is that in some cases, manufacturing in the U.S. does not rely on ISO 13485. The question is: how can a manufacturer in the EU demonstrate equivalence when it comes to the Quality Management System (QMS)? This can be a challenge, but if FDA continues with the approach we in the EU view as positive, focusing on reliance on ISO 13485, it could help ensure greater consistency and allow manufacturers to more effectively use U.S.-generated data.

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Do combination products require a Clinical Evaluation Report (CER)? Some notified bodies (NB) require a CER for NBOP, and others don't?

Wright: I’m afraid the answer is: it depends. If a combination product is a single-use drug delivery system, it is primarily governed by the EU Community Code of Medicinal Products, which covers the authorization of medicinal products. However, the drug delivery component must comply with the medical device legislation.

For example, if it’s a syringe-based drug delivery system, often with software, it might be classified as a Class I device, which requires self-assessment. In that case, you would need a Clinical Evaluation Report (CER), but it wouldn’t be particularly onerous.

If it’s a medical device with software that performs a specific function, then yes, a CER would be required.

For a multi-use combination product, you would need to comply with all the rules under the Community Code and the MDR, which includes the need for a CER.

Is published literature a sufficient data source for devices that have sufficient data and only need general objectives or monitoring?

Wright: Yes, but unfortunately, there are no specific guidelines on this.

In my experience, if you want to rely on published literature, it should be peer-reviewed. The literature must be up-to-date, relevant, and of high quality. You can absolutely rely on it, and the EU regulations state you can use literature. While it doesn't explicitly say it must be peer-reviewed, in practice, that’s what is typically required.

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How far apart should Post-Market Clinical Follow-up (PMCF) activities occur within the PMCF plan to properly monitor the safety and performance of a medical device and remain compliant with the regulation?

Wright: I’m afraid this also depends. Let’s simplify it a bit:

When you put a medical device on the market, you need to allow time and volume of use to generate data that demonstrates the device’s safety and performance.

For your Post-Market Clinical Follow-up and Periodic Safety Update Report (PSUR), you’ll need to assess these regularly. The PSUR should generally be done within a year, or at most within two years, depending on the nature of the device.

In my experience, once a device is on the market, you should start generating data right away. This is particularly important for safety, though performance is often the key focus. You need clear criteria for determining whether the device performs as intended.

For most devices, the PSUR should be completed within a year, so you'll likely need to start the monitoring process as soon as valid, credible data can be collected.

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Are there approvals based on reliance on the U.S. or EU? If a product is approved in other countries, can that approval be used to approve the product submission without performing a regular analysis of the documentation?

Wright: In the U.S., you cannot rely on clinical data generated in other countries unless there is a subsidiary involved. As for technical data, I’m afraid I can't give a clear answer on that.

However, in the EU, it is not uncommon for manufacturers to rely on data generated in countries like Australia, New Zealand, and Japan, apart from the U.S. These countries' data, including clinical data, can be used to support the development of a Clinical Evaluation Report (CER) for conformity assessment in the EU.

That said, you still need to demonstrate equivalence, which is crucial in these cases.

Finally, how long can a system remain under equivalence before you are required to have data on the subject device?

Wright: That depends on your notified body's position. However, generally, when relying on an equivalent device to support your conformity assessment for the CE mark, the notified body will expect you to develop a robust Post-Market Surveillance Plan and a Post-Market Clinical Follow-up plan. In short, you need to start generating your own data and have a clear plan in place for what you’ll do next, even if you initially relied on an equivalent device for conformity assessment.

About the Author

Omar Ford

Omar Ford is a veteran reporter in the field of medical technology and healthcare journalism. As Editor-in-Chief of MD+DI (Medical Device and Diagnostics Industry), a leading publication in the industry, Ford has established himself as an authoritative voice and a trusted source of information.

Ford, who has a bachelor's degree in print journalism from the University of South Carolina, has dedicated his career to reporting on the latest advancements and trends in the medical device and diagnostic sector.

During his tenure at MD+DI, Ford has covered a wide range of topics, including emerging medical technologies, regulatory developments, market trends, and the rise of artificial intelligence. He has interviewed influential leaders and key opinion leaders in the field, providing readers with valuable perspectives and expert analysis.

 

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