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. With some exceptions, the new regulation must be fully adopted by 26 May 2020.

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.

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Get informed directly by our experts how to adopt the MDR requirements to your company with a minimum of effort.

 

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