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Opinion
Letzte Aktualisierung: February 17, 2022

The medical device regulatory framework must be further developed

By Marc-Pierre Möll
Marc-Pierre Möll is Managing Director of the German Medical Technology Association BVMed.
The EU Medical Device Regulation (MDR) has been in force since May 2021. The aim of the MDR is to harmonize the requirements for medical devices throughout Europe and to increase safety. The MedTech industry fully shares this goal, says Marc Pierre Möll from the German Medical Technology Association (BVMed). However, the system is not yet practical.
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.
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