New MDCG 2024-16 on ‘Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices’

In December 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-16, providing the ‘Manufacturer Information Form’ on the interruption or discontinuation of supply of certain devices. It also includes an Annex with the ‘Device Identification Table’.

For more, see the Commission’s web page on Guidance.

Revised Q & A on ‘Obligation to inform in case of interruption or discontinuation of supply’

In December 2024, the European Commission revised the question and answers (Q & A) document on practical aspects related to the implementation of the obligations to inform in case of interruption or discontinuation of supply of certain deviceslaid down in the new Articles 10a of Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

For more, see the Commission’s web page on Guidance.

Revised MDCG 2023-3 on ‘Questions and Answers on vigilance terms and concepts as outlined in Regulation (EU) 2017/745 and Regulation (EU) 2017/746’

In January 2025, the Medical Device Coordination Group (MDCG) endorsed a new revised version of the document MDCG 2023-3 rev.2 on questions and answers on vigilance terms and concepts as outlined in Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

For more, see the Commission’s web page on Guidance.

Revised MDCG 2021-16 on ‘Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)’

In January 2025, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2021-16 rev.1 with the application form to be submitted by a conformity assessment body when applying for designation as notified body under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It also includes an Annex with the ‘List of documents submitted with the application’.

For more, see the Commission’s web page on Guidance.

Revised MDCG 2021-15 on ‘Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR)’

In January 2025, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2021-15 rev.1 with the application form to be submitted by a conformity assessment body when applying for designation as notified body under Regulation (EU) 2017/745 on medical devices (MDR). It also includes an Annex with the ‘List of documents submitted with the application’.

For more, see the Commission’s web page on Guidance.

Revised MDCG 2024-8 on ‘Preliminary assessment review (PAR) form template (IVDR)’

In January 2025, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2024-8 rev.1 with the preliminary assessment review (PAR) form template for Regulation (EU) 2017/746 on medical devices (IVDR). It also includes an Annex with the ‘List of documents submitted with the application’.

For more, see the Commission’s web page on Guidance.

Revised MDCG 2024-7 on ‘Preliminary assessment review (PAR) form template (MDR)’

In January 2025, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2024-7 rev.1 with the preliminary assessment review (PAR) form template for Regulation (EU) 2017/745 on medical devices (MDR). It also includes an Annex with the ‘List of documents submitted with the application’.

For more, see the Commission’s web page on Guidance.

Revised MDCG 2021-12 on ‘FAQ on the European Medical Device Nomenclature (EMDN)’

In January 2025, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2021-12 rev.1 with frequently asked questions (FAQ) on the European Medical Device Nomenclature (EMDN).

For more, see the Commission’s web page on Guidance.

Revised MDCG 2024-2 on ‘Procedures for the updates of the EMDN’

In January 2025, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2024-2 rev.1 on procedures for the updates of the European Medical Device Nomenclature (EMDN).

For more, see the Commission’s web page on Guidance.

New MDCG 2025-1 on ‘EMDN Ad hoc procedure’

In January 2025, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2025-1 with the European Medical Device Nomenclature (EMDN) ad hoc procedure form.

For more, see the Commission’s web page on Guidance.

New MDCG 2025-2 on ‘Summary of EMDN 2024 Submissions and outcome of annual revision’

In January 2025, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2025-2 with the summary of the European Medical Device Nomenclature (EMDN) submissions from the 2024 public consultation and the MDCG Subgroup on Nomenclature, and the outcome of annual revision.

For more, see the Commission’s web page on Guidance.

New MDCG 2025-3 on ‘EMDN Version History’

In January 2025, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2025-3 on the European Medical Device Nomenclature (EMDN) version history.

For more, see the Commission’s web page on Guidance.

We are continuing to support the implementation of the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)! Keeping you informed about the latest developments and all relevant news and events is a priority.

Updates on the latest initiatives, publications, consultations, meetings and much more can be found here in this February 2025 Newsletter!

For more information and regular updates, please consult our website here.

Revised MDCG 2019-6 on ‘Questions and answers: Requirements relating to notified bodies’

In February 2025, the Medical Device Coordination Group (MDCG) endorsed a new revised version of the document MDCG 2019-6 rev.5 with questions and answers on requirements relating to notified bodies.

For more, see the Commission’s web page on Guidance.

EUHPP Training Tuesdays (4/4): the floor is yours! A 45-minute Q&A session with the EU HPP management team (25 February 2025, 11.00 - 11.45 CET)

REMINDER - EUHPP Webinar: EU recommendations on treatment and health care for patients with Functional Disorders and Persistent Physical Symptoms (24 February 2025)

Recording and presentation - EUHPP Webinar: Identifying, measuring and reducing low-value care in the context of health system performance assessment (13 February 2025)

Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP)

REMINDER - EUHPP webinar on European Health Data Space (1/3): Primary Use of health data and Electronic Health Record Systems (18 February 2025, 11:00 - 12:30 (CET))

Study on the design of a monitoring framework of the EU OH Action Plan against AMR and Council Recommendation on stepping up EU actions to combat AMR in a OH approach