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Q&A Part 1: EU’s Medical Device Regulation

Questions still linger about the EU's MDR and its effects on packaging. What challenges lie ahead?

Questions still linger about the EU's MDR and its effects on packaging. What challenges lie ahead?
Questions still linger about the EU's MDR and its effects on packaging. What challenges lie ahead?

In May, the European Parliament approved the final version of its Medical Device Regulation (MDR)—repealing the existing Medical Device Directive—with the goal of developing a regulatory framework that supports a high level of safety and innovation for medical devices.

In this Q&A, Kelli Anderson from Network Partners talks about the new MDR, including how up-classification will affect manufacturers and how the regulations are impacting notified bodies.

HCP: What do you think might be the biggest difference between the requirements of FDA’s device requirements and the EU’s MDR?

Kelli Anderson: The biggest difference is going to be how EU allows you to use a “similar,” or reference device, in your approval process. In the U.S., your predicate device can be a competitor’s device. Typically, the only information you will have on that device is going to be what you can gather on the Internet. In Europe, with the new MDR, utilization of a “similar” device in your application is going to require you to have access to technical design and performance specifications. This means that unless your competition is willing to share these details, your similar device is going to have to be a device already in your product portfolio. For large companies already in the market, this will not impact them. However it will make it very difficult, if not impossible, for start-up companies with novel technology to gain EU approval.

HCP: If companies don't meet the new requirements, they won’t be able to market their devices in the EU, even if they’ve been marketing their device and packaging for years?

KA: There is a transition period defined in Article 120 of the new MDR. CE certificates issued by a Notified Body prior to May 25, 2017 shall remain valid until expiration, which is five years. Certificates issued after May 25, 2017 and before implementation of the MDR, will remain valid until the certificate expiration date, or become void as of May 24, 2024.

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