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 in 2024 (quarter & year are highlighted in bold).
Notified bodies Oversight (NBO)
- Update of MDCG 2022-13 guidance on best practice guidance on designation and notification – Q2 2024
- Form for Corrective and Preventive Action plan – Q2 2024
- Revision of NBOG F 2017-5 and -6 (PAR forms) – Q2 2024
- PAR forms for re-assessment – Q2 2024
- Guidance on “appropriate surveillance” according to Article 120(3) MDR – Q2 2024
- Update of best practice guidance on the information required for the conformity assessment bodies’ personnel involved in conformity assessment activities – 2024
- Notified Body Technical Documentation Assessment Report (PSUR section delivered first) – 2024
- Revision of MDCG 2019-13 Guidance on sampling of devices for the assessment of the technical documentation – 2024
- Minor revision of MDCG 2021-14 – 2024
- Q&A on requirements notified bodies – update of MDCG 2019-6 – 2024
Standards
- Extension and improvement of MDCG 2021-5 guidance on standardisation for medical devices – Q2 2024
Clinical Investigations and Evaluation (CIE)
- Update of the MDCG 2019-9 on summary of safety and clinical performance – Q1 2024
- Guidance on content of Investigator’s Brochure for clinical investigations conducted under MDR – Q1 2024
- Update of the clinical evaluation guidance – Q3 2024
- Clinical investigation Q&A document – End 2024
Post-Market Surveillance and Vigilance (PMSV)
- DSVG for transvaginal urogynaecological surgical mesh implants – Q1 2024
- Update of MIR form, MIR pdf file, MIR Helptext and related documents – Q2 2024
- Revision of MIR Q&A document – Q2 2024
- Guidance on Post-Market Surveillance – Q2 2024
- Extension of Q&A documents on Vigilance terms and concepts to IVDR requirement – Q2 2024
- MDR Vigilance guidance on implementation of Articles 87 to 90 MDR – Q2 2024
- Revision of Trend report and related documents – Q2 2024
- Revision of Field Safety Corrective Action form – Q3 2024
- Extension of PSUR guidance to IVDR – Q3 2024
Borderline & Classification
- Exploratory paper on qualification of products specifically intended for the cleaning, disinfection or sterilisation of devices – Q2 2024
- Minor revision of classification guidance MDCG 2021-24– Q3 2024
- Procedures for notification of decision on dispute – Q4 2024
New Technologies
- Document on the legal status of app providers – Q4 2024
- Targeted revision of MDCG 2019-11 – Q4 2024
- FAQ document on interplay between MDR/IVDR and AIA – Q4 2024
Unique Device Identification (UDI)
- Guidance on Master UDI-DI – Q2 2024
In Vitro Diagnostic Medical Devices (IVD)
- Minor revision of MDCG 2020-16 – Q1 2024
- Guidance on IVD borderline issues – Q1 2024
- Common specifications for hepatitis E, Plasmodium, Toxoplasma and arboviruses – Q2 2024
- Q&A/guidance on distance sales – Q3 2024
- Guidance on Research Use Only devices – Q4 2024
- Minor revision of MDCG 2023-1 – definition of ‘health institution’ – Q4 2024
- Questions and Answers document on performance studies – 2024
- Template and guidance for safety reporting in performance studies under IVDR – 2024
- Minor revision of MDCG 2021-14 – Explanatory note on IVDR codes – 2024
- Analysis of IVDR in context of hypothetical scenarios of an urgent response to a health crisis – 2024
Nomenclature
- FAQ on EMDN – Q3 2024
- Tool for EMDN definitions – 2025
Other
- Guidance on certificates under conditions – 2024
- Guidance for manufacturers and notified bodies on the application of clinical evaluation requirements to orphan devices in view of their certification in accordance with the MDR – 2024
- Revision of MDCG 2021-25 ‘Application of MDR requirements to “legacy devices” and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or
93/42/EEC – 2024
You can find the document in our Library of documents – MDCG icon.
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