Timeline for MDCG guidance documents updated

The European Commission has released the updated document on the ongoing work of the MDCG and its subgroups. We present you below some of the most relevant group deliverables and planned endorsement by the MDCG (quarter & year are highlighted in bold).

Notified Bodies

  • Updates of guidance documents and templates on the designation and re-assessment process Notified bodies – 2021
  • Updates of guidance documents and templates on qualification and authorisation of personnel Notified bodies 2021
  • Guidance on appropriate surveillance according to MDR Article 120(3) –  Q3 2021
  • Batch verification on class D IVDsQ4 2021

Clinical Investigations and Evaluation 

  • Guidance on Periodic Safety Update Report requirements – Q4 2021 [PSUR for MDR to be later adapted for IVDR]
  • Guidance on Post-Market Surveillance requirementsQ2 2022
  • Q&A document on Vigilance terms and conceptsQ4 2021
  • Q&A document on Art 87 to 90 on Vigilance requirements –  Q3 2022
  • Development of harmonised reporting forms for incidents – Q1 2022

Market Surveillance

  • Update of PRRC Guidance – 2022
  • Authorised Representatives – 2021
  • Q&A on Importers & Distributors 2021

Borderline & Classification

  • Borderline with medicinal products (including general guidance, definitions of pharmacological, immunological and metabolic means of action and diagnosis) – 2021

New Technologies

  • Legal status of app provider – 2021

Unique Device Identification (UDI)

  • Q&A on UDI- 2021

In Vitro Diagnostic Medical Devices (IVD)

  • Performance evaluation – 2022
  • SSP (Summary of Safety & Performance) template 2022
  • In-house devices2022


  • Rules for allocation of EMDN to UDI-DI – Q3 2021
  • 2nd release of EMDN – Q3 2021
  • Procedures for the annual and ad-hoc updates of EMDN – Q3 2021

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

Do not forget to follow us on LinkedIn.

Leave a Reply

Your email address will not be published.