- medical device
About the event
Did you know that we all use medical devices? Sometimes, even as part of our daily lives.
What changes on 26 May 2021 and what is your role as a patient or consumer?
This webinar, held on 7 May 2021, summarised how the new Medical Device Regulation (MDR) aims to ensure safe and performant medical devices for all.
The event was organised by the Directorate-General for Health and Food Safety (DG SANTE) of the European Commission in the context of the Communication campaign for the new medical devices legislation, an initiative supported by the Third Health Programme 2014 – 2020.
It brought together representatives of the European Commission, patients, consumers, health professionals and anyone interested to know more about the new legislation. The webinar was held in English.
New legislation on medical devices Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) revise the existing framework of the current 3 directives. The MDR and IVDR were adopted in May 2017 and will become applicable in May 2021 and May 2022, respectively.
For any updates regarding the new provisions and requirements, please be sure to check DG SANTE's New Regulations webpages on a regular basis.
Keep up to date by subscribing to the Health and Food Safety newsletter and check regularly:
- Public Health - Medical Devices
- New Regulations, including dedicated factsheets
- Getting ready, including guidance documents
- MDCG and MDCG subgroups
- Experts panels
- Eudamed as the new European database on medical devices, currently under development
- Publications, including factsheets on New Regulations for manufacturers of medical devices, manufacturers of in vitro devices, authorised representatives/ importers/ distributors, competent authorities in non-EU/EEA countries, healthcare professionals and health institutions and for the procurement ecosystem
- Video clip: