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 IVDs – Q4 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 requirements – Q2 2022
- Q&A document on Vigilance terms and concepts – Q4 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 devices – 2022
Nomenclature
- 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.
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