On 5th of April new legislation act was adopted, it was published in the Official Journal of the European Union L117, volume 60, on 5th of May. It withdraw and supersede the existing regulations:
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
The new regulation will be obliged after transitional period that is 3 years after coming into force.We offer full care and consulting during this transition period so that you can adapt to new requirements.
This new rule is much more strict and its aim is to:
- Improve the quality, safety and reliability of medical devices
- Strengthen transparency of information for consumers
- Enhance vigilance and market surveillance