The MDR Deadline Extension: Use the Time Wisely On March 15, 2023, the European Parliament amended the original Medical Device Regulation (MDR) to lengthen the compliance period for certain medical devices and in vitro diagnostic devices. The move provides device manufacturers with additional time to prepare their products for market and offers a buffer …
Beyond EU MDR: Unleashing Opportunities to Innovate and Ensure Patient Safety A harmonious blend of innovation and patient safety is paramount in today’s ever-evolving medical device regulatory landscape. Furthermore, sustainability of massive regulatory data, updates to the evolving regulations, adherence to country-specific requirements, and adoption of an intelligent yet cost-effective approach to reducing overhead …
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Clock Starts for New EU MDR Transition Dates An extension to the EU MDR transition period, approved by the European Council on March 7, is now in force following its publication in the Official Journal of the European Union on March 20. Producers of medical devices will now have until December 31, 2027, for …
The Real Impact of IVDR on Clinical Evidence Requirements For many manufacturers of IVD devices now on the European market, meeting the evidence required of the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will require tremendous work. With the shortage of notified bodies and resources, numerous outstanding guidance questions, as well as …
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State-of-the-Art: Unpacking MDR’s Evolving Requirements The Oxford Dictionary defines “state-of-the-art” as something that belongs or relates to the most recent stage of technological development. It is something that incorporates the newest technology, ideas and features. In short, state-of-the-art means the most advanced, sophisticated, innovative version of a thing. The European Union’s Medical Device Regulation …
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