The medical device regulation MDR (EU) 2017/745
The new European Medical Device Regulation MDR (EU) 2017/745 came into force on 25 May 2017. It replaces the two European Directives 93/42/EEC and 90/385/EEC. Due to the postponement of the implementation deadlines as decided by the EU Parliament on 17 April 2020, the new MDR (EU) 2017/745 must now – apart from a few exceptions – be fully implemented by 26 May 2021.
New requirements and regulations for medical devices:
- Common European law, binding for all EU member countries
- More precise specifications for planning clinical evaluations
- Tightening of the requirements for the quality of clinical data, equivalence discussions and waiving clinical investigations
- Detailed regulation for the approval of clinical investigations
- Tightening of regulations governing post market surveillance and vigilance
- New classification rules for material-based medical devices, additional rules for products with nanomaterials and software
- Introduction of a consultation procedure involving an expert panel for specific class IIb and class III devices
- New rules for the reprocessing of single-use devices
- Introduction of the Unique Device Identification (UDI) system
- Extension of the European database for medical devices (EUDAMED)
- Manufacturers are obliged to nominate a responsible qualified person
We help you comply with the requirements of MDR (EU) 2017/745
As service provider, SCC pilots you through the new regulation, ensuring smooth implementation:
- We offer training in which you learn how to implement the MDR in your company, helping you adopt the required procedures in line with ISO 13485.
- In close collaboration with you, we perform a gap analysis and develop individual concepts aimed at re-establishing conformity.
- With respect to the limited experience and uncertainty concerning the interpretation of the changes included in the MDR, we – as an independent party – clarify your open issues and negotiate acceptable solutions with notified bodies and authorities. Together with you, we develop an implementation strategy best fitted to your needs.
- We will also advise you on what the postponement by the EU Parliament of 17 April 2020 means for the implementation strategy in your company.
Get informed directly by our experts how to adopt the MDR requirements to your company with a minimum of effort.