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The MDCG have published their latest ongoing guidance update.

The following IVDR-related documents are included in this list:

  • Notified bodies Q&A on requirements notified bodies – update of MDCG 2019-6 (Permanent work item, no estimated date)
  • Standards Updates of guidance document MDCG 2021-5 on standardisation for medical devices (Estimated Q2 2023)
  • Post-market surveillance and vigilance Guidance on Post-Market Surveillance requirements (Estimated Q2 2023)
  • Post-market surveillance and vigilance Development of harmonised reporting forms for incidents (Estimated Q2 2023)
  • Post-market surveillance and vigilance Revision of Trend report and associated files (Estimated Q2 2023)
  • Market surveillance Update MDCG 2021-27 Q&A on Importers & Distributors (Estimated Q2 2023)
  • Market surveillance Update MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 (Estimated Q2 2023)
  • Market surveillance Update MDCG 2019-7 of PRRC Guidance (Estimated Q2 2023)
  • IVDR Minor revision of MDCG 2022-9 – Summary of Safety and Performance Template (Estimated Q2 2023)
  • IVDR Transposition of MEDDEV 2.14/1 – IVD borderline issues for use under IVDR (Estimated Q2 2023)
  • IVDR Poss. minor revision of MDCG 2022-10 – Interplay between CTR/IVDR (Estimated Q2 2023)
  • IVDR Analysis of IVDR in context of hypothetical scenarios of an urgent response to a health crisis (Estimated Q2 2023)
  • Post-market surveillance and vigilance Extension of guidance on Periodic Safety Update Report to IVDR requirements (Estimated Q3 2023)
  • Post-market surveillance and vigilance Extension of Q&A documents on Vigilance terms and concepts to IVDR requirements (Estimated Q3 2023)
  • Post-market surveillance and vigilance Extension of Q&A document on Vigilance terms and concepts to IVDR requirements (Estimated Q3 2023)
  • IVDR Questions and Answers document on performance studies (Estimated Q3 2023)
  • IVDR Template and guidance for safety reporting in performance studies under IVDR (Estimated Q3 2023)
  • Post-market surveillance and vigilance MDR Vigilance guidance on Articles 87 to 90 (Estimated Q4 2023)
  • IVDR Common specifications for hepatitis E class D devices (Estimated Q4 2023)
  • IVDR Common specifications for Plasmodium and Toxoplasma class D devices (Estimated Q4 2023)
  • IVDR Minor revision of MDCG 2020-16 – Classification of IVDs (Estimated Q4 2023)
  • Notified bodies Updates of guidance documents and templates on the designation and re-assessment process (Estimated 2023)
  • IVDR Minor revision of MDCG 2021-14 – Explanatory note on IVDR codes (Estimated 2023)
  • Notified bodies Revision of MDCG 2019-13 Guidance on sampling of devices for the assessment of the technical documentation (Estimated 2023)
  • Notified bodies Updates of guidance documents and templates on qualification and authorisation of personnel (Estimated 2024)
  • IVDR Common specifications for arbovirus (Zika, West Nile Virus, Chikungunya, dengue) class D devices (Estimated 2024)
Ashleigh