The European Medical Device Regulation (MDR) — New requirements for dental laboratories
The safe handling of medical devices is now regulated by the new EU Medical Device Regulation (MDR), which takes effect in May 2021. Get an overview of the most important changes and benefit from practice-oriented tips for implementation.
In May 2021, the Medical Device Regulation (MDR), the new European regulation on medical devices, will take effect on a binding basis. The implementation of the EU Medical Device Regulation into national law replaces the Medical Devices Act (MPG) previously applicable in Germany. The Medical Device Regulation (MDR) uniformly determines the requirements for medical devices that were manufactured in the EU in regard to their placement of on the market, their availability on the market, commissioning, as well as use and surveillance of such products.
As manufacturers of custom-made devices according to MDR, dental laboratories are also affected by this new regulation. In our lecture we would like to present the most important changes:
- Requirements of the new MDR for manufacturers of custom-made devices
- Risk Management
- Conformity Assessment
- CE Marking
- Post Market Surveillance
Subject to change