“MDR”. With its acronym that echoes the abbreviation commonly used in the language of text messages to mean “laughing,” the new European regulations on medical devices (Medical Device Regulation) would almost make you smile. But, in the aisles of the symposium organized by the national union of the medical technology industry (Snitem), which was held Monday, March 14 in Paris, business leaders were far from hilarious. “There is an urgent need to react. We are heading towards a catastrophic situation”is indignant, on the stage, one of them, greeted by applause.
At the heart of their concerns: the deadline imposed by the European Commission to have their medical products approved according to the new standards. Entering into force on May 26, 2021, the new regulations oblige manufacturers in the sector to have all their medical devices certified under the CE mark before May 26, 2024. Catheters, implants, prostheses, medical beds, syringes, compresses, etc. Everything must be reviewed from top to bottom, including products marketed for years, and which already have approval.
Only then, the great spring cleaning carried out by the European Commission turns into a nightmare. Overwhelmed by the unprecedented influx of files, the European certification bodies authorized to give the precious stamp are no longer able to keep up. At the beginning of December 2021, they sounded the alarm, worrying about the congestion of their services.
Administrative traffic jam
Especially since the new MDR regulations do not content themselves with imposing a general review on the 450,000 medical devices marketed on the continent. It also provides for a serious tightening of the data required to certify each product. “It’s simple, in the past, the files were 800 pages, now they are more than 8,000”, summarizes Guirec Le Lous, president of Urgo, at the head of the MedTech in France association. Result: almost eighteen months of waiting per file, on average, to win sesame.
The administrative traffic jam has only just begun. Of the 20,000 to 25,000 files expected by 2024, only 3,500 had been submitted by early 2022 to notified bodies, of which barely 500 were able to be fully processed and obtain their CE marking. Enough to blow a wind of panic among manufacturers. Because, without the stamp before the deadline, manufacturers will no longer have the right to sell their products.
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