Question 6181 — health

Summary

Mr. Quentin Bataillon draws the attention of the Minister of the Economy, Finance and Industrial and Digital Sovereignty to the issue of “CE” marking for medical devices. This can only be issued by authorities capable of certifying a device, which are called Notified Bodies (NO). There are a number of them in Europe. Two G-MED branches exist in France, one of which is in Saint-Etienne. THE G-Med employees are doing remarkable work, but a major difficulty is weakening the entire system. Indeed, European regulations on medical devices have recently been tightened, to be even more selective, for the benefit of patients and to limit risks. Examination times for certification requests for complex MDs have become extremely long and we are now talking about 12 to 18 months. For young start-ups French women such as Kéranova in Saint-Etienne who still have no income, this could be dramatic. He therefore questions the possibility of setting up a “priority” deadline for start-ups with an examination time reduced to 4 months, if the file does not present any particular difficulties.

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