The EU MDR and IVDR implementing acts and guidance tracker

The following Life Sciences practice note provides comprehensive and up to date legal information covering:

  • The EU MDR and IVDR implementing acts and guidance tracker
  • Scope and definitions—Chapter I
  • Guidance
  • Common specifications, qualification of devices, obligations of economic operators—Chapter II
  • Implementing acts
  • Guidance and factsheets
  • EUDAMED and European Medical Device Nomenclature (EMDN)—Chapter III
  • Implementing regulations and acts
  • Guidance
  • Other initiatives
  • More...

The EU MDR and IVDR implementing acts and guidance tracker

This Practice Note tracks the progress of implementing acts, guidance and key initiatives to assist stakeholders in implementing the EU regulatory framework for medical devices and in vitro diagnostic medical devices (IVDs) set out in Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)) (together the MD Regulations). For an overview of the MD Regulations and their requirements, see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation.

This tracker is based on the information available on the European Commission—Public Health website—Medical Devices sector, which includes:

  1. the guidance documents endorsed by the Medical Device Co-ordination Group (MDCG)

  2. the MDCG ongoing guidance documents

  3. the MDR and IVDR implementing measures rolling plan (the rolling plan)

  4. the MDR/IVDR roadmap (dated November 2017), produced by the competent authorities for medical devices project (CAMD) and the Commission (the CAMD roadmap)

  5. the MDCG joint implementation and preparedness plan for IVDR

In March 2020, the MDCG published the joint implementation/preparedness plan on the MDR (MDCG joint MDR preparedness plan) which emphasises the priorities and necessary tasks that Member States and the Commission share together with concerned stakeholders as a joint responsibility that must be achieved for the implementation of the MDR by 26 May 2020 (which should read

Popular documents