MEDICAL DEVICES NEWS

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.

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.

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 2025-1 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.

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.

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 2024-7 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 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 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 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 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 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.

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 MDCG 2022-3 on ‘Verification of manufactured class D IVDs by notified bodies’

In December 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2022-3 rev.1 on verification of manufactured class D in vitro diagnostic medical devices (IVDs) by notified bodies.

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

Revised MDCG 2019-13 on ‘Guidance on sampling of devices for the assessment of the technical documentation’

In December 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2019-13 rev.1 providing guidance on sampling of devices for the assessment of the technical documentation.

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

New MDCG 2024-15 on ‘Guidance on the publication of the clinical investigation reports and their summaries in the absence of Eudamed’

In November 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-15 providing guidance on the publication of the clinical investigation reports and their summaries in the absence of the European database on medical devices (Eudamed).

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

New Q & A on the gradual roll-out of Eudamed

In November 2024, the European Commission issued a new question and answers (Q & A) document on practical aspects related to the implementation of the gradual roll-out of the European database on medical devices (Eudamed) pursuant to Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) as amended by Regulation (EU) 2024/1860.

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

New MDCG 2024-14 on ‘Guidance on the implementation of the Master UDI-DI solution for contact lenses’

In November 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-14 providing guidance on the implementation of the ‘Master UDI-DI’ solution for contact lenses, as introduced by Commission Delegated Regulation (EU) 2023/2197.

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

New MDCG 2024-13 on ‘Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices’

In October 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-13 on the regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices.

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

Revised MDCG 2022-5 on ‘Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices’

In October 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2022-5 rev.1 providing guidance on the borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices (MDR).

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

Factsheet for Procurement Ecosystem of medical devices and in vitro diagnostic medical devices

In December 2024, the European Commission issued a revised and updated version of the Factsheet for Procurement Ecosystem of medical devices and in vitro diagnostic medical devices.

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

Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices

In December 2024, the European Commission issued a revised and updated version of the Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices.

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

Factsheet for healthcare professionals and health institutions

In December 2024, the European Commission issued a revised and updated version of the Factsheet for healthcare professionals and health institutions.

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

Updated notified bodies survey on certifications and applications (MDR/IVDR)

In October 2024, the European Commission issued the latest update of the notified bodies (NB) survey on certifications and applications under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It contains the results of the 10^th NB survey with data status 30 June 2024 (small and medium dataset).

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

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

In February 2025, the Expert panels on medical devices and in vitro diagnostic devices (Expamed) published an Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP).

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

Advice on SARS-CoV-2 on request from the Medical Device Coordination Group

In January 2025, the in vitro diagnostic medical devices (IVD) expert panel, on request from the Medical Device Coordination Group (MDCG), provided new scientific advice on SARS-CoV-2. This information may affect how SARS-CoV-2 tests are classified under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

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

List of views provided under the PECP

In November 2024, the European Commission issued the list of views in the context of the Performance Evaluation Consultation Procedure (PECP) by the expert panels on medical devices and in vitro diagnostic devices (Expamed).

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

Latest meetings of the Medical Device Coordination Group (MDCG)

The latest meetings of the Medical Device Coordination Group (MDCG) took place in December 2024 and in February 2025 with national competent authorities, including sessions with the sectorial stakeholders.

For more, see the information on the MDCG meetingon 17 to 18 December 2024, the meeting between the MDCG and stakeholderson 17 December 2024, the MDCG meeting on 18 to 19 February 2025 and the meeting between the MDCG and stakeholders on 18 February 2025 from the Register of Commission Expert Groups and Other Similar Entities.

The list of 2025 planned meetings of MDCG and Subgroupsis available from the Commission’s web page on Medical Device Coordination Group Working Groups.

EMA regular procedure for scientific advice on certain high-risk medical devices

In February 2025, the European Medicines Agency (EMA) announced the establishment of a regular procedure for manufacturers to request scientific advice on the intended clinical development strategy for certain high-risk medical devices.

The advice procedure is available for two types of medical devices: class III devices: invasive and sustain or support human life; class IIb active devices: intended to administer or remove medicines.

Pilot coordinated assessment for clinical investigations and performance studies (CI/PS): call for applications

In February 2025, the European Commission launched a call for applications for expression of interest to participate in an EU pilot coordinated assessment of clinical investigations (CI) and performance studies (PS) across multiple Member States as per Articles 78 of Regulation (EU) 2017/745 on medical devices (MDR) and 74 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), respectively.

The call is open until 30 June 2025.

For more, see the Commission’s web page on Clinical investigations and performance studies.

Public consultation and call for evidence for the targeted evaluation of the EU Regulations on medical devices

In December 2024, the European Commission launched a public consultation with an EUSurvey questionnaireand a call for evidence on the EU legislation on medical devices (Regulation (EU) 2017/745, MDR) and in vitro diagnostic medical devices (Regulation (EU) 2017/746, IVDR), as part of the targeted evaluation of these rules.

The consultation and call for evidence are open until 21 March 2025.

For more, see the Commission’s ‘Have your say’ page on EU rules on medical devices and in vitro diagnostics – targeted evaluation.

Survey on the status of the implementation of the MDR and IVDR

In December 2024, the second survey round for economic operators dealing with medical devices and in vitro diagnostic medical devices within the ‘Study supporting the monitoring of availability of medical devices on the EU market’ was launched.

The survey, specifically addressed to medical device (MD) and in vitro diagnostic medical device (IVD) manufacturers, authorised representatives, importers and distributors, is open until 28 February 2025.

For more, see the Commission’s web page on the Study supporting the monitoring of availability of medical devices on the EU market.

Dashboard update for the ‘Study supporting the monitoring of availability of medical devices on the EU market’

In November 2024, the dashboard of the ‘Study supporting the monitoring of the availability of medical devices on the EU market’ was updated.

For more, see the Commission’s web page on the Study supporting the monitoring of availability of medical devices on the EU market.

COMBINE programme for clinical trials and medical devices endorsed by Member States

In December 2024, national authorities in Member States endorsed a new strategy for the COMBINE programme for clinical trials and medical devices, a cross-sector initiative to streamline combined studies of medicines and medical devices, including diagnostics.

For more, see the Commission’s webpage on Combined studies.

European Medical Device Nomenclature (EMDN): revisions and training sessions

In January 2025, the first revision of the European Medical Device Nomenclature (EMDN)was made available after a broad consultation process that included stakeholders from around the world. The 2025 cycle of public consultation has been launched via the EMDN submission platform, open to all interested to provide their input to the annual revision.

In November 2024, the EU hosted a training session on the EMDN. The training materials from this event are available here. Further sessions will take place to ensure that all interested parties can benefit from the work.

New legislative initiatives in support of the MDR and IVDR

In December 2024, on the ‘Have your say’ portal, the Commission published information on new legislative initiatives (implementing and delegated acts) in support of Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) as indicated below.

• Medical devices - spectacle frames, lenses and ready-made reading glasses (unique identifiers)
• Implementing regulation for electronic instructions for use for medical devices
• Establishment of an expert panel on orphan and paediatric devices
• Expansion of the list of well-established technologies
• Reclassification of well-established technologies
• Implementing rules regarding uniform application of requirements to be met by notified bodies

These initiatives are planned to be adopted during 2025.

Keep in touch online!

To stay uptodate on all information related to medical devices and in vitro medical devices, visit the Medical Devices section on the European Commission’s Public Health website regularly.

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