Substance-based medical devices before and after May 26, 2021
The proDERM webinar on the effects of the medical device regulation
On October 29, 2020, at 3 p.m. CET, we will host the webinar ‘Substance-based medical devices before and after May 26, 2021’. Bernd Brormann, Director Clinical Operations at proDERM, will discuss aspects of the Medical Device Regulation that will come into force on May 26th, 2021 and in particular the implications for the category of ‘Substance-based medical devices’. The following topics will be presented:
- Background and objective of the new medical device regulation
- Definition of ‘material medical devices’ – the classification rule 21
- Risk classes of material medical devices according to old and new regulation
- Requirements for market approval – clinical trial or proof of equivalence?
- Regulatory environment
- Differentiation from medicinal products
- Active pharmaceutical ingredients in medical devices
The webinar will take approximately 60 minutes and will end with a Q&A session.