New Timeline for MDCG Guidance Documents for 2023

The European Commission Directorate-General for Health and Food Safety has released the updated document on the ongoing work of the MDCG and its subgroups. You can see below the most significant goals and planned endorsement by the MDCG divided per subgroups:

Notified Bodies

  • Updates of guidance documents and templates on the designation and re-assessment process under MDR & IVDR – 2023
  • Updates of guidance documents and templates on qualification and authorisation of personnel – 2024
  • Notified Body Technical Documentation Assessment Report – 2023
  • Revision of MDCG 2020-3 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regards to devices covered by certificates according to MDD or AIMDD – 2023
  • Revision of MDCG 2019-13 Guidance on sampling of devices for the assessment of the technical documentation – 2023


  • Updates of guidance document MDCG 2021-5 on standardisation f, or medical devices – Q2 2023

Clinical Investigations and Evaluation (CIE)

  • Clinical Investigation Report Summary Template – Q1 2023                                                                                                        

Post-Market Surveillance and Vigilance (PMSV)

  • Extension of guidance on Periodic Safety Update Report to IVDR requirements – Q3 2023
  • Extension of Q&A documents on Vigilance terms and concepts to IVDR requirements – Q3 2023
  • Guidance on Post-Market Surveillance requirements – Q2 2023

Unique Device Identification (UDI)

  • Guidance on Master UDI-DI – Q3 2023

In Vitro Diagnostic Medical Devices (IVD)

  • Q&A document on performance studies – Q3 2023
  • Template and guidance for safety reporting in performance studies under IVDR – Q3 2023
  • Transposition of MEDDEV 2.14/1 – IVD borderline issues for use under IVDR – Q2 2023
  • Common specifications for hepatitis E class D devices – Q4 2023
  • Common specifications for Plasmodium and Toxoplasma class D devices – Q4 2023
  • Common specifications for arbovirus (Zika, West Nile Virus, Chikungunya, dengue) class D devices – 2024


  • Procedures for the annual and ad-hoc updates of the EMDN – After Q2 2023
  • FAQ on EMDN – After Q2 2023

Annex XVI

  • Guidance document on the classification of Annex XVI products – Q2 2023
  • Q&A document on the transitional provisions established by the Annex XVI common specifications – Q1 2023

You can find the full document in our Library of documents – MDCG icon.

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