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The New European Medical Device Regulation MDR

The New European Medical Device Regulation MDR

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FOR WHOM IS THE COMPENDIUM WRITTEN?

On more than 566 pages, the new European Medical Device Regulation (MDR) describes in 123 articles and 17 annexes the new requirements for the registration and CE marking of medical devices in the EU, which is replacing the medical device directives (MDD) and the directive for active implantables medical devices (AIMD).

This compendium is a quick overview of the new MDR and is intended to give the interested reader an easier access to the complex subject matter. The compendium is predominantly designed as a question-and-answer text and deals with the most important aspects of the medical device regulation.

HIGHLIGHTS:

  • Key elements of the new MDR
  • EU Conformity Assessment Procedures
  • Economics Operators
  • Unique Device Identifi cation (UDI) system
  • The European Databank (Eudamed)
  • Medical Device Coordination Group (MDCG)
  • Liability coverage
  • Authorised representative
  • Re-classsifi cation of certain medical devices
  • Scrutiny process for certain class III and Class IIb devices
  • Reprocessing single-use devices
  • Products with aesthetic or non-medical purpose
  • Tissues or cells of human origin
  • Clinical investigation
  • Vigilance and Post-Market Surveillance