FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

MedTech Europe Raises New Concerns Over MDR/IVDR Timelines

Aug. 10, 2018
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MedTech Europe sounded a new alarm about the limited time available to implement the EU’s new medical device regulations and in vitro diagnostic regulations that go online May 2020 and May 2022 respectively.

The association is calling on regulators to either extend the critical dates to May 2022 for all products, or to stop the clock and freeze the remaining transition time until the system is ready.

Although devicemakers are investing heavily to comply with the new regulations and will be ready to submit files to maintain the supply of devices to the market, regulators have been slow in implementing needed infrastructure to enable the regulatory system to work, the association said.

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