New Medical Device Regulations (MDR) - May 2017
We are pleased to update you
on new regulation for medical devices officially published May 5th.
- Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017 on medical instruments, amendment of Directive 2001/83 / EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and the abolition of Council provisions 90/385 / EEC and 93/42 / EEC ·
- Regulation (EU) 2017/746 of the European Parliament of the Council of 5 April 2017 on in vitro diagnostic medical instruments and the abolition of Directive 98/79 / EC and the Commission decision 2010/227 / EU
The new regulation will replace the current MDD within three years.
Contact us to consult the adoption of the new regulation