The Medical Device Regulation and the In-Vitro Diagnostic Regulation were published in the EU Official Journal on 05 May 2017. This provides manufacturers and distributors the transitional period of 3 years for MDR and 5 years for IVDR to prepare their company for the new requirements.

 

Comprehensive changes by MDR are inter alia:

  • directives become regulations
  • 93/42/EWG and 90/385/EWG become MDR
  • 98/79/EG becomes IVDR
  • 32 new executing and 11 delegated legal acts
  • 5 new appendixes
  • Almost 100 articles more than the MDD
  • New classification rules, especially regarding the software
  • new „scrutiny-procedure“ for high-risk products
  • content and extent of the technical documentation are regulated more detailed
  • all products have to be labeled with an explicit identification number (UDI)
  • manufacturer have to state one person responsible for regulative issues
  • the European Database EUDAMED is extended und supposed to become the central hub for medical devices
  • clinical assessments and examinations are regulated more detailed
  • increasing unannounced audits by the notified bodys
  • Increasing and more detailed requirements for the post market surveillance
  • Comprehensive changes for the OEM manufacturers

 

Prepare now for the challenges of the MDR and IVDR. Together with you we analyze your technical documentation and help you to resolve the evaluated gap!

With senetics you are in safe hands! We help you to prepare the new tasks!