The 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.”