Device Makers Could Face Approval Lags Under New EU Rule

By Bloomberg Law, December 2018

The European Union compliance clock is ticking for the medical device industry, including giants like Medtronic Inc., Fresenius Medical Care, and Stryker Inc.

They’re facing a deadline of May 26, 2020, to get their products recertified as compliant with the EU’s new Medical Device Regulation (MDR). It replaces a decades-old regulatory framework in the EU. There could be a logjam of applicants and delayed approvals and supply disruptions if device companies don’t start preparing now to meet the new requirements, three device industry specialists told Bloomberg Law.

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