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Q&A Part 2: EU’s Medical Device Regulation

Questions still linger about the EU's MDR and its effects on packaging. Experts talk timing and packaging innovation.

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 second installment of our Q&A session, Kelli Anderson and Jane Severin from Network Partners talk about the new MDR, including timelines and innovation. [Editor’s note: We recommend reading Part 1 first, which offers information about the regulations, notified bodies and upclassification.]

MDR timeline

HCP: What have you found surprising about the MDR timeline?

Kelli Anderson: Once the MDR was finalized and approved by Parliament in May 2017, the implementation phase started. The first part of the implementation phase is actually going to be used up by the notified bodies because they have to be re-certified.

Technically, device companies have a three-year transition period. IVD companies have a longer transition period, but the device companies can't start their activities with their notified body until the body has been re-certified. Not all the notified bodies are going to survive because a lot of them are not equipped to handle the increased burden being placed on them.

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