MDR / IVDR
Regulatory development in Europe
The two European regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) entered into force on May 25, 2017. After a transition period ...
- May 26, 2021 ... MDR
- May 26, 2022 ... IVDR
... the respective regulations become valid and must be applied. The relevant directives will be largely repealed on the date of validity of the respective regulation - this means directives 90/385/EEC, 93/42/EEC and directive 98/79/EC.
The following corrections were made to the regulations:
- Corrigendum to the European Medical Devices Regulation (EU) 2017/745
- Corrigendum to the European Regulation (EU) 2017/746 on in vitro diagnostic medical devices
In April 2020, the publication of the Regulation amending Regulation (EU) 2017/745 on medical devices regarding the date of application of some of its provisions took place.
Regarding the transitional provisions in the regulations, FAQ documents were prepared and published by the European authorities:
- Transitional Provisions to Regulation (EU) 2017/745 on Medical Devices.
- Transitional provisions to Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
For the implementation of the MDR and IVDR, a roadmap was developed and published by the European authorities, in which work packages for the respective European working groups are formulated.
Further information on the MDR and IVDR is also published on the website of the European Commission.
Guidelines(MDCG documents) are being developed at the European level for the harmonized implementation of the regulations. The guidelines are published on the website of the European Commission.
