A respite for “made in Europe” prostheses and implants


Manufacturers of medical equipment will have more time to comply with the European regulation. 112046589/Monstar Studio – stock.adobe.com

The application of a European regulation, which risked leading to delistings, should be postponed.

This is a relief for medtechs, these manufacturers of medical equipment (prostheses, implants, etc.). Barring a dramatic change, the sector will have more time to comply with the European regulation on medical devices (known as “MDR”, for “Medical Device Regulation”). The 1,500 companies in the sector would thus have until 2027-2028 to have their products certified, and no longer until May 2024. “The European Commission has proposed extending the transition period from three to four years, deciphers Guirec Le Lous, head of the professional union Medtech in France (93% of SMEs). This proposal was adopted unanimously by the European Ministers of Health, a decisive step. We are hopeful that the European Parliament will agree to amend the text following the recommendations of the Commission.” It was France that stepped up to the plate in Brussels, after rallying the German government. A letter signed by the Ministers of Health and the Economy…

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