The European Commission updated its “rolling plan” for adopting implementing acts and other actions/initiatives ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

The update follows the delay of implementation of the MDR by one year amid COVID-19 and the decision to postpone Eudamed’s rollout by two years last December.

The plan is divided into two sections: implementing acts, and other actions/initiatives.

The part Implementing acts contains following subjects:

  • Notified bodies scope of Designation
  • Reprocessing of single-use medical devices
  • Common specifications for products without a medical purpose
  • Setting up of expert panels
  • Setting up of expert laboratories
  • Setting up of new structures under IVDR: – EU reference laboratories
  • Rules to facilitate fulfilment of tasks by EU reference laboratories and to ensure their compliance with criteria
  • Fees for EURL services
  • Unique Device Identification (UDI) System: designation of issuing entities
  • EUDAMED
  • Common specifications for IVD Class D

 The part Actions/initiatives (other than implementing regulations/acts) contains following subjects:

  • Notified Bodies designation
  • EUDAMED go-live

For more information, please see the original Implementation rolling plan document from European Commission or download it from the EC website.

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