The new regulation requires the manufacturers of the sector to certify under the marking EC of the entire devices before May 26, 2024. Including those marketed for years and already approved.
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“mdr”. With his acronym that echoes the abbreviation commonly used in the text language to signify “dead laugh”, the new European regulation on medical devices (Medical Device Regulation) would almost smile. But, in the aisles of the Symposium organized by the National Union of the Medical Technology Industry (SNITEM), which stood on Monday, March 14 in Paris, the business leaders were far from being Hilares. “There is urgency to react. We go to a catastrophic situation”, is indignant, on the stage, one of them, greeted by applause.
At the heart of their concerns: the time limit imposed by the European Commission to approve their medical products according to the new standards. Entry into force on May 26, 2021, the new regulation requires the manufacturers of the sector to be certified under the CE marking all their medical devices before May 26, 2024. Catheters, implants, prostheses, medical beds, syringes, compresses … Everything must be seen from the bottom, including the products marketed for years, and already have approval.
Only that is, the great spring household made by the European Commission turns to a nightmare. Overflowed by the unprecedented influx of files, the European certification organizations empowered to give the precious buffer stroke can no longer follow the pace. In early December 2021, they rang the alarm, worrying about the congestion of their services.
Administrative bottling
Especially since the new MDR regulations are not content to impose a general review with the 450,000 medical devices marketed on the continent. It also provides for a serious screw tower on the data required to certify each product. “It’s simple, formerly, the files made 800 pages, now they make more than 8,000”, summarizes Guirec the Lous, President of Urgo, at the head of the MedTech in France. Result: Nearly eighteen months of waiting by file, on average, to pick up sesame.
The administrative bottling is just beginning. Of the 20,000 to 25,000 records awaited by 2024, only 3,500 had been filed, beginning 2022, with notified bodies, of which 500 hardly could be fully treated and obtain their CE marking. What to blow a panic wind from the manufacturers. Because, without the buffer before the deadline, the manufacturers will no longer have the right to sell their products.
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