Letzte Aktualisierung: February 17, 2022
The medical device regulatory framework must be further developed
By Marc-Pierre Möll
The MDR is a watershed. The requirements for market access of medical devices, for the life cycle of the product, and for notified bodies are increasing significantly. The new regulatory framework affects not only new medical devices, but also all proven and safe existing products, as well as specialty products, such as those for small patient populations. All Notified Bodies must go through a lengthy European designation process. The review time for the more extensive files is significantly increased.