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Home » MDR reportedly causing medtech companies to leave EU market

MDR reportedly causing medtech companies to leave EU market

December 20, 2022 By Chris Newmarker

Flag of the European Union or EU which has a new Medical Device Regulation or MDRThe EU’s new Medical Devices Regulation (MDR) has created enough compliance costs that some medtech companies have stopped selling there., according to a report from Reuters.

Reuters spoke with eight companies, including the Swedish medtech giant Getinge, who are either withdrawing from the EU market or have stopped making medical devices. The costs of complying with the MDR were simply too much.

The EU’s MDR went into effect in 2021. Medical device makers have had until 2024 to transition previously certified devices to the new standard.

Reuters reports that European doctors’ groups are already reporting medical equipment shortages. The Russia-Ukraine war has caused material shortages that have further exacerbated the problem.

EU leaders have become aware of the problems. The EU Health Commissioner Stella Kyriakides has proposed extending the transition deadline to 2027 for high-risk devices — 2028 for medium- and low-risk products. She also would like to do away with a sell-off date of May 2025 to prevent the needless disposal of devices presently on the market.

A higher compliance bar under the MDR

As Lisa Bartakovics of Avery Dennison Medical recently explained on our Medical Design & Outsourcing sister site, the MDR has a higher bar than the EU’s previous Medical Device Directive (MDD). Just as important, the EU isn’t allowing grandfathering into the new framework.

Said Bartakovics: “The MDR requires the legal manufacturer of a device to provide an extensive technical dossier about every product it seeks to sell in the EU. For many devices, there are heightened requirements for post-market surveillance and documentation than there were under the MDD.”

Filed Under: Business/Financial News, Featured, News Well, Regulatory/Compliance Tagged With: EU MDR, European Union, Getinge

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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