On 5 April 2017, the two new EU Regulations on medical devices were adopted by the European Parliament:
- Regulation (EU) 2017/745 on medical devices (MDR)
- Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR).
These regulations replace the existing Medical Device Directives:
- Directive on active implantable medical devices 90/385/EEC (AIMD)
- Directive concerning medical devices 93/42/EEC (MDD)
- Directive on in-vitro diagnostic medical devices 98/79/EEC (IVDD)
The new Regulations entered into force on 26 May 2017 and shall apply after graduated transitional periods, ranging from 6 months to 5 years, in Spring 2020 (MDR) or Spring 2022 (IVDR), respectively.
Further information can be found on the EU Commission website (in English):
and on the CAMD (Competent Authorities for Medical Devices) website: