Foreword (20/02/2025)

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’ (20/02/2025)

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’ (20/02/2025)

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’ (20/02/2025)

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’ (20/02/2025)

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’ (20/02/2025)

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)’ (20/02/2025)

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)’ (20/02/2025)

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)’ (20/02/2025)

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)’ (20/02/2025)

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)’ (20/02/2025)

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’ (20/02/2025)

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’ (20/02/2025)

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’ (20/02/2025)

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’ (20/02/2025)

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’ (20/02/2025)

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’ (20/02/2025)

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 (20/02/2025)

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’ (20/02/2025)

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’ (20/02/2025)

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’ (20/02/2025)

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 (20/02/2025)

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 (20/02/2025)

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 (20/02/2025)

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) (20/02/2025)

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) (20/02/2025)

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 (20/02/2025)

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 (20/02/2025)

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) (20/02/2025)

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 (20/02/2025)

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 (20/02/2025)

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 (20/02/2025)

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 (20/02/2025)

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’ (20/02/2025)

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 (20/02/2025)

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 (20/02/2025)

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 (20/02/2025)

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! (16/05/2024)

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.

Register with the stakeholder database to stay informed and receive the quarterly newsletter.

Definitive adoption of new amendment to the Medical Device Regulation (MDR) and In Vitro Medical Device Regulation (IVDR) (18/10/2024)

Definitive adoption of new amendment to the Medical Device Regulation (MDR) and In Vitro Medical Device Regulation (IVDR)

As proposed by the European Commission in January 2024, on 13 June 2024 the European Parliament and the Council adopted Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) as regards a gradual roll-out of the European Database on Medical Devices (Eudamed), the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.

In July 2024, the Commission published a Q & A document on the extension of the IVDR transitional periods and updated its Q & A document on the extension of the MDR transitional periods. All the related texts, guidance and supporting information are available on the Commission’s web page on the Extension of the transition periods provided for in the Regulations.

Latest meeting of the Medical Device Coordination Group (MDCG) (18/10/2024)

Latest meeting of the Medical Device Coordination Group (MDCG)

The meeting on 14 to 15 October 2024 of the Medical Device Coordination Group (MDCG) took place with national competent authorities and a session with the sectorial stakeholders.

For more, see the information on the MDCG meeting on 14 to 15 October 2024 and the meeting between the MDCG and stakeholders on 14 October 2024 from the Register of Commission Expert Groups and Other Similar Entities.

The updated list of 2024 planned meetings of MDCG and Subgroups is available from the Commission’s web page on Medical Device Coordination Group Working Groups.

Renewal of designations of issuing entities for UDIs (18/10/2024)

Renewal of designations of issuing entities for UDIs

On 30 July 2024, the European Commission adopted Implementing Decision (EU) 2024/2120 renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices.

For more, see the Commission’s web page on Unique Device Identifier - UDI.

2024 sessions of the IMDRF (18/10/2024)

2024 sessions of the IMDRF

The second 2024 session of the Management Committee of the International Medical Device Regulators Forum (IMDRF), hosted by the U.S. Food & Drug Administration (FDA), took place from 16 to 20 September 2024 in Seattle, Washington.

For more, see the IMDRF website and the Commission’s web page on International Cooperation.

Applicability of the MDR/IVDR standardisation request as amended (18/10/2024)

Applicability of the MDR/IVDR standardisation request as amended

The second amendment (M/575 Amd 2) to the European Commission’s standardisation request (M/575) in support of Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was adopted and accepted by the European standardisation organisations, CEN and CENELEC in June 2024. This makes the MDR/IVDR standardisation request fully applicable as amended, and valid until December 2028.

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

‘NoBoCap’ Community Summit 2024 (18/10/2024)

‘NoBoCap’ Community Summit 2024

On 24 and 25 September 2024, the ’NoBoCap’ Community Summit took place. The ‘NoBoCap’ project is co-funded under the EU4Health programme of the European Union and aims to assess and increase the capacity of notified bodies designated under the EU Regulations on medical devices and in vitro diagnostic medical devices.

For more, see the NoBoCap web site.

New publications in the OJEU of references of harmonised standards in support of the MDR and IVDR (18/10/2024)

New publications in the OJEU of references of harmonised standards in support of the MDR and IVDR

On 9 October 2024, two Commission Implementing Decisions were published in the Official Journal of the European Union (OJEU) with new references of harmonised standards in support 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 Harmonised standards.

Survey on monitoring the availability of medical devices on the EU market (18/10/2024)

Survey on monitoring the availability of medical devices on the EU market

In the context of the ‘Study supporting the monitoring of the availability of medical devices on the EU market’, a survey for health service providers (individual health professionals, health institutions and medical device procurement bodies) was launched. It is open until 31 October 2024.

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

Results of 1st MF/AR survey on the availability of medical devices on the EU market (18/10/2024)

Results of 1^st MF/AR survey on the availability of medical devices on the EU market

In the context of the ‘Study supporting the monitoring of the availability of medical devices on the EU market’, the Commission published a ‘Study overview and survey results of the 1st manufacturers (MF) / authorised representatives (AR) survey with data status 31 October 2023’.

The dashboard on monitoring of availability of medical devices on the EU market was updated accordingly.

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

New MDCG 2024-12 on ‘Corrective and preventive action plan assessment’ (18/10/2024)

New MDCG 2024-12 on ‘Corrective and preventive action plan assessment’

In October 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-12 on corrective and preventive action (CAPA) plan assessment, to provide guidance and templates for conformity assessment bodies, notified bodies (NBs), designating authorities (DAs) and joint assessment teams (JATs). Two forms have been added: MDCG 2024-12 Annex I Template CAPA plan and assessment and MDCG 2024-12 Annex II Template JAT review of the CAPA and the DA’s opinion.

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

Updates on the applications for designation as a notified body under the MDR and the IVDR (18/10/2024)

Updates on the applications for designation as a notified body under the MDR and the IVDR

The European Commission updated the available information on the applications for designation as a notified body under Regulations (EU) 2017/745 on medical devices (MDR) and 2017/746 on in vitro diagnostic medical devices (IVDR) as an overview at each stage of the process.

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

New MDCG 2024-11 on ‘Qualification of IVDs’ (18/10/2024)

New MDCG 2024-11 on ‘Qualification of IVDs’

In October 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-11 to provide guidance on qualification of in vitro diagnostic medical devices (IVDs).

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

Updated Eudamed timeline (18/10/2024)

Updated Eudamed timeline

The European Commission updated the timeline for the implementation of the European database on medical devices (‘Eudamed’) as Current planning for gradual roll out and modules’ functionality view.

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

New MDCG 2024-10 on ‘Clinical evaluation of orphan medical devices’ (18/10/2024)

New MDCG 2024-10 on ‘Clinical evaluation of orphan medical devices’

In June 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-10 to provide guidance to manufacturers and notified bodies on clinical evaluation of orphan medical devices.

Following publication of MDCG 2024-10, in September 2024 the European Medicines Agency (EMA), in cooperation with the Commission, organised an online Information session on the pilot for expert panels’ advice for orphan medical devices.

Manufacturers of high-risk medical devices and notified bodies are invited to apply for the pilot programme for free scientific advice by the expert panels on possible orphan device status and on the clinical evaluation of orphan medical devices. For more, see the EMA’s website.

New MDCG 2024-6, 7, 8 and 9 with ‘Preliminary assessment and re-assessment review templates’ (18/10/2024)

New MDCG 2024-6, 7, 8 and 9 with ‘Preliminary assessment and re-assessment review templates’

In June 2024, the Medical Device Coordination Group (MDCG) endorsed the new documents MDCG 2024-6, MDCG 2024-7, MDCG 2024-8 and MDCG 2024-9, providing templates to be used by authorities responsible for notified bodies to document the review of the conformity assessment body’s application for designation (preliminary assessment review, PAR) as well as the review of the notified body’s documentation for re-assessment (preliminary re-assessment review, PRAR) under 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.

EU reference laboratories for high-risk in vitro diagnostic medical devices start working on their tasks (18/10/2024)

EU reference laboratories for high-risk in vitro diagnostic medical devices start working on their tasks

On 1 October 2024, the designation of EU reference laboratories (EURLs) for certain high-risk (class D) in vitro diagnostic medical devices (IVDs) came into application for the purpose of the EURLs’ tasks, to carry out the tasks laid down in Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Notably, as of this date, notified bodies will approach the EU reference laboratories for batch testing and performance verification of IVDs.

There are five laboratories covering four categories of class D IVDs: those detecting or quantifying hepatitis and retroviruses, herpesviruses, bacterial agents and respiratory viruses that cause life-threatening diseases.

For more, see the Commission’s web page on IVD EU reference laboratories.

New MDCG 2024-1-5 on ‘DSVG 05 on urogynaecological surgical mesh implants’ (18/10/2024)

New MDCG 2024-1-5 on ‘DSVG 05 on urogynaecological surgical mesh implants’

In June 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-1-5 DSVG 05 as Device Specific Vigilance Guidance (DSVG) 05 on urogynaecological surgical mesh implants used for pelvic organ prolapse repair and stress urinary incontinence.

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

Revised MDCG 2022-13 on ‘Designation, re-assessment and notification of conformity assessment bodies and notified bodies’ (18/10/2024)

Revised MDCG 2022-13 on ‘Designation, re-assessment and notification of conformity assessment bodies and notified bodies’

In June 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2022-13 rev.1 providing guidance on designation, re-assessment and notification of conformity assessment bodies and notified bodies under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The revision of the document includes guidance on the conduct of joint assessments relating to extending the scope of designations.

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

Revised MDCG 2022-4 on ‘Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR’ (18/10/2024)

Revised MDCG 2022-4 on ‘Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR’

In May 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2022-4 rev.2. This provides guidance on appropriate surveillance regarding the transitional provisions under Article 120 of Regulation (EU) 2017/745 on medical devices (MDR) with regard to devices covered by certificates according to the previous Directives 93/42/EEC (MDD) or 90/385/EEC (AIMDD). The document was revised to take into account provisions introduced by Regulation (EU) 2023/607 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

For more, see the Commission’s webpage on Guidance.

Revised MDCG 2021-25 on ‘Application of the MDR requirements to legacy devices’ (18/10/2024)

Revised MDCG 2021-25 on ‘Application of the MDR requirements to legacy devices’

In July 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2021-25 Rev.1 providing guidance on the application of Regulation (EU) 2017/745 on medical devices (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.

For more, see the Commission’s webpage on Guidance.

Revised MDCG 2021-5 on ‘Guidance on standardisation for medical devices’ (18/10/2024)

Revised MDCG 2021-5 on ‘Guidance on standardisation for medical devices’

In July 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2021-5 Rev.1 providing guidance on standardisation for medical devices.

For more, see the Commission’s webpage on Guidance.

Revised MDCG 2021-4 on ‘Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746’ (18/10/2024)

Revised MDCG 2021-4 on ‘Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746’

In September 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2021-4 rev.1 providing guidance on application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746.

For more, see the Commission’s webpage on Guidance.

Revised MDCG 2020-16 on ‘Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746’ (18/10/2024)

Revised MDCG 2020-16 on ‘Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746’

In July 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2020-16 rev.3 providing guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746.

For more, see the Commission’s webpage on Guidance.

Updated SCHEER guidelines on the ‘Benefit-risk assessment of the presence of phthalates in certain medical devices’ (18/10/2024)

Updated SCHEER guidelines on the ‘Benefit-risk assessment of the presence of phthalates in certain medical devices’

In June 2024, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) updated the Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties.

For more, see the Commission’s webpage on Guidance.

Expert panel’s advice on Monkeypox virus (18/10/2024)

Expert panel’s advice on Monkeypox virus

In June 2024, the Advice from the medical device Expert Panels on Monkeypox virus was published.

For more, see the Commission’s webpage on Expert Panels.

Adoption of new amendment to the MDR and IVDR (22/05/2024)

Adoption of new amendment to the MDR and IVDR

On the basis of the Commission proposal in January 2024, on 25 April 2024 the European Parliament adopted a new amendment to Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) as regards a gradual roll-out of the European database on medical devices (Eudamed), the obligation to inform in case of interruption or discontinuation of supply, and the transitional provisions for certain in vitro diagnostic medical devices. After the formal adoption by the Council as well, expected in May, the amending Regulation will enter into force on the day of its publication in the Official Journal of the European Union (OJEU).

The text of the amending Regulation and supporting information are available on the Commission’s webpage on extension of the transition periods provided for in the regulations.

Adoption of the second amendment to the MDR/IVDR standardisation request (22/05/2024)

Adoption of the second amendment to the MDR/IVDR standardisation request

On 24 April 2024, the Committee on Standards under Regulation (EU) No 1025/2012 on European standardisation delivered a positive opinion on the draft second amendment to the European Commission’s standardisation request (M/575) as amended (M/575 Amd 1) in support of Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). After the formal adoption of the Commission Implementing Decision as M/575 Amd 2, the act will be addressed to CEN and CENELEC for their acceptance, to become fully applicable.

This second amendment extends the validity of the MDR/IVDR standardisation request and the deadlines for the adoption of certain harmonised standards until 2028. Moreover, it adds and removes some standardisation items in Annexes I and II, and clarifies certain contents and requirements in Annex III.

For more, see the Commission’s webpage on harmonised standards.

New publications in the OJEU of references of harmonised standards in support of the MDR and IVDR (22/05/2024)

New publications in the OJEU of references of harmonised standards in support of the MDR and IVDR

On 8 March 2024, two Commission Implemented Decisions were published in the Official Journal of the European Union (OJEU) with new references of harmonised standards in support of Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). There are now 25 references of harmonised standards under the MDR and 13 under the IVDR to confer presumption of conformity with the requirements the standards aim to cover. 

For more, see the Commission’s webpage on harmonised standards.

New MDCG 2024-6, 7, 8 and 9 as preliminary (re-)assessment review form templates for MDR and IVDR (22/05/2024)

New MDCG 2024-6, 7, 8 and 9 as preliminary (re-)assessment review form templates for MDR and IVDR

In May 2024, the Medical Device Coordination Group (MDCG) endorsed the documents MDCG 2024-6 Preliminary assessment review (PAR) form template (MDR), MDCG 2024-7 Preliminary assessment review (PAR) form template (IVDR), MDCG 2024-8 Preliminary re-assessment review (PRAR) form template (MDR) and MDCG 2024-9 Preliminary re-assessment review (PRAR) form template (IVDR). They have been developed by the MDCG Subgroup on Notified Body Oversight (NBO).

For more, see the Commission’s webpage on guidance.

New MDCG 2024-5 on 'Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices' (22/05/2024)

New MDCG 2024-5 on ‘Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices’

In April 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-5 to provide guidance on content of the Investigator’s Brochure for clinical investigations of medical devices. It includes an Appendix A with cross-references between requirements in Annex XV chapter II of the MDR and the Clinical Investigation submission package.

For more, see the Commission’s webpage on guidance.

New MDCG 2024-4 on 'Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746' (22/05/2024)

New MDCG 2024-4 on ‘Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746’

In April 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-4 on safety reporting in performance studies of in vitro diagnostic medical devices under the IVDR. It includes an Appendix with a Performance Study Summary Safety Reporting Form.

For more, see the Commission’s webpage on guidance.

Revised MDCG 2022-9 on ‘Summary of safety and performance template’ (22/05/2024)

Revised MDCG 2022-9 on ‘Summary of safety and performance template’

In April 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the document MDCG 2022-9 Rev.1 providing a summary of safety and performance template for in vitro diagnostic medical devices under the IVDR.

For more, see the Commission’s webpage on guidance.

New MDCG 2024-3 on ‘Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices’ (22/05/2024)

New MDCG 2024-3 on ‘Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices’

In March 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-3 to provide guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices. It includes an Appendix A with a Clinical Investigation Plan Synopsis Template.

For more, see the Commission’s webpage on guidance.

Notified bodies survey on certifications and applications (22/05/2024)

Notified bodies survey on certifications and applications

In March 2024, the Commission published the updated version of the Notified Bodies Survey on certifications and applications (MDR/IVDR) - Survey results of the 6^th NB survey with data status 31 October 2023 (small, medium and large dataset).

For more, see the Commission’s webpage on notified bodies.

Annual overview of devices subject to the clinical evaluation consultation procedure (CECP) – July 2022 - June 2023 (22/05/2024)

Annual overview of devices subject to the clinical evaluation consultation procedure (CECP) – July 2022 - June 2023

In March 2024, the Commission published the Annual overview of devices subject to the clinical evaluation consultation procedure (CECP) for the period July 2022 - June 2023.

For more, see the Commission’s webpage on Expert Panels – List of opinions provided under the CECP.

Advice on the indirect antiglobulin tests on request from the Medical Device Coordination Group (22/05/2024)

Advice on the indirect antiglobulin tests on request from the Medical Device Coordination Group

In March 2024, the Commission published the advice provided by the IVD Expert Panel on the indirect antiglobulin tests. The Medical Device Coordination Group (MDCG) requested this on the basis of Article 106 (10) (a) and (b) of Regulation (EU) 2017/745 on medical devices (MDR).

For more, see here.

New MDCG 2024-2 on ‘Procedures for the updates of the EMDN’ (22/05/2024)

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

In February 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-2 on the Procedures for the updates of the European Medical Device Nomenclature (EMDN).

For more, see the Commission’s webpage on guidance.

New MDCG 2024-1 on ‘Guidance on the vigilance system for CE-marked devices and DSVG Templates’ (22/05/2024)

New MDCG 2024-1 on ‘Guidance on the vigilance system for CE-marked devices and DSVG Templates’

In January 2024, the Medical Device Coordination Group (MDCG) endorsed the new document MDCG 2024-1 DSVG 00 on Guidance on the vigilance system for CE-marked devices, with Device Specific Vigilance Guidance (DSVG) Templates on Cardiac ablation (MDCG 2024-1-1 DSVG 01), Coronary stents and associated delivery systems (MDCG 2024-1-2 DSVG 02), Cardiac implantable electronic devices (MDCG 2024-1-3 DSVG 03) and Breast implants (MDCG 2024-1-4 DSVG 04).

For more, see the Commission’s webpage on guidance.

New guidance document on MDR/IVDR Language requirements (22/05/2024)

New guidance document on MDR/IVDR Language requirements

In January 2024, the Commission issued a guidance document on MDR/IVDR Language requirements. It provides an overview of language requirements for medical device manufacturers covered by Regulation (EU) 2017/745 (MDR) and in vitro diagnostic medical devices covered by Regulation (EU) 2017/746 (IVDR) for the information and instructions that accompany a device in a specific country. The document was updated in March 2024.

For more, see the Commission’s webpage on guidance.

2024 sessions of the IMDRF (22/05/2024)

2024 sessions of the IMDRF

The first 2024 session of the International Medical Device Regulatory Forum (IMDRF), hosted by the U.S. Food and Drug Administration (FDA), took place from 11 to 15 March 2024 in Washington, DC.

A video developed during the 2023 EU Chair was published on the IMDRF website.

For more, see the IMDRF website and the Commission’s webpage on International Cooperation.

Meetings of the Medical Device Coordination Group (MDCG) (22/05/2024)

Meetings of the Medical Device Coordination Group (MDCG)

Meetings on 6-7 February 2024 and 13-14 May 2024 of the Medical Device Coordination Group (MDCG) took place with national competent authorities as well as sessions with the sectorial stakeholders.

For more, see the information on the MDCG meeting on 6-7 February 2024, the meeting between the MDCG and stakeholders on 6 February 2024, the MDCG meeting on 13-14 May 2024 and the meeting between the MDCG and stakeholders on 13 May 2024 from the Register of Commission Expert Groups and Other Similar Entities.

The updated list of 2024 planned meetings of MDCG and Subgroups is available from the Commission’s webpage on Medical Device Coordination Group Working Groups.

Updates on the applications for designation as a notified body under the MDR and the IVDR (22/05/2024)

Updates on the applications for designation as a notified body under the MDR and the IVDR

The European Commission updated the available information on the applications for designation as a notified body under Regulations (EU) 2017/745 on medical devices (MDR) and 2017/746 on in vitro diagnostic medical devices (IVDR) as an overview at each stage of the process.

For more, see the Commission’s webpage on Notified Bodies.

New project on combined studies (22/05/2024)

New project on combined studies

The European Commission, together with national authorities, ethics committees, the European Medicines Agency and stakeholders presented a report to analyse the current challenges faced when conducting combined studies and possible ways forward to streamline the regulatory landscape. The initiative is conducted in the context of the COMBINE project addressing combined studies, in which medicinal products are assessed together with medical devices or in vitro diagnostic medical devices.

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

Dashboard on monitoring of availability of medical devices on the EU market (22/05/2024)

Dashboard on monitoring of availability of medical devices on the EU market

In January 2024, in the context of the ‘Study supporting the monitoring of availability of medical devices on the EU market’, the Commission developed a dashboard presenting an overview of the data gathered from different stakeholders. In addition, comparable data from previous surveys of notified bodies conducted by the Commission have been integrated into the dashboard.

Report and dashboard on reprocessing of single-use devices (22/05/2024)

Report and dashboard on reprocessing of single-use devices

The Commission outsourced a study on the implementation of the provisions on reprocessing of single-use devices established in the Medical Devices Regulation. The final report and the interactive dashboard of the ‘Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market’ were published in April 2024.

For more, see here and the Commission’s webpage on reprocessing of medical devices.

First outcomes of the EU JAMS 2.0 project - Joint Action on Reinforced Market Surveillance for Medical Devices (22/05/2024)

First outcomes of the EU JAMS 2.0 project - Joint Action on Reinforced Market Surveillance for Medical Devices

JAMS 2.0 is a Joint Action co-funded by the European Union under the EU4Health programme involving 24 EU Member States. The goal is to reinforce the market surveillance for medical devices and in vitro diagnostic devices and to foster cooperation between National Competent Authorities (NCAs). The project started in November 2023 and runs for 36 months with several activities across 8 technical and operational work packages.

For more information and the first project outcomes, see here.

Foreword (18/12/2023)

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, surveys, publications, meetings, events and much more are here in this December newsletter!

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

Keep in touch online! (19/12/2023)

Keep in touch online!

Stay up-to-date 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. Register with the stakeholder’s database here to stay up-to-date and receive the quarterly newsletter.

Online stakeholder survey in the context of the “Study on Regulatory Governance and Innovation in the field of Medical Devices” (19/12/2023)

Running until 31 January 2024.

Online stakeholder survey in the context of the “Study on Regulatory Governance and Innovation in the field of Medical Devices”

Within the ongoing “Study on Regulatory Governance and Innovation in the field of Medical Devices”, the European Commission has launched an online stakeholder survey on different aspects related to regulatory governance and innovation for medical devices and in vitro diagnostic medical devices. The survey is available here.

Meeting of the Employment, Social Policy, Health and Consumer Affairs Council - Health (30/11/2023)

Meeting of the Employment, Social Policy, Health and Consumer Affairs Council - Health

Meeting on 30 November 2023, the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) - Health discussed a point on the implementation of the Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). For more, see here. 

Publication in the OJEU of Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers (UDIs) for contact lenses (19/12/2023)

Publication in the OJEU of Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers (UDIs) for contact lenses

After the scrutiny by the European Parliament and the Council, the Commission Delegated Regulation of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses has been published in the Official Journal of the European Union (OJEU): see OJ L, 2023/2197, 20.10.2023. It will become applicable from 9 November 2025. 

Update of MDCG 2022-11 Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements (19/12/2023)

Update of MDCG 2022-11 Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements

The Medical Device Coordination Group (MDCG) endorsed MDCG 2022-11 Rev.1, an update of the position paper with the notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements. The update includes a new section “Call to notified bodies to streamline the certification process” and a revision of the section “Call to manufacturers to transition to the Regulations and submit their applications for certification without further delay”. For more, see the Commission’s webpage on Guidance.

Online survey for MD and IVD manufacturers and authorised representatives on the status of MDR and IVDR implementation (19/12/2023)

Running until 15 January 2024.

Online survey for MD and IVD manufacturers and authorised representatives on the status of MDR and IVDR implementation

Updates on the applications for designation as a notified body under the MDR and the IVDR (19/12/2023)

Updates on the applications for designation as a notified body under the MDR and the IVDR

The European Commission updated the available information on the applications for designation as a notified body under Regulations (EU) 2017/745 on medical devices (MDR) and 2017/746 on in vitro diagnostic medical devices (IVDR) as an Overview at each stage of the process. For more, see the Commission’s webpage on Notified Bodies.

Updated MDR/IVDR notified bodies survey on certifications and applications (19/12/2023)

Survey results with data status 30 June 2023

Updated MDR/IVDR notified bodies survey on certifications and applications

The European Commission updated the document with the Notified bodies 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), with data status 30 June 2023. For more, see the Commission’s webpage on Notified Bodies.

Meetings of the Medical Device Coordination Group (MDCG) (19/12/2023)

Meetings of the Medical Device Coordination Group (MDCG)

Meetings on 10-11 October 2023 and on 11-12 December 2023 of the Medical Device Coordination Group (MDCG) took place with national competent authorities as well as sessions with the sectorial stakeholders. For more, see the information on the meeting between the MDCG and stakeholders on 10 October 2023, the MDCG meeting on 10-11 October 2023 and the MDCG meeting on 11-12 December 2023 from the Register of Commission Expert Groups and Other Similar Entities. The updated lists of 2023 planned meetings of MDCG and Subgroups and the new 2024 planned meetings of MDCG and Subgroups are available from the Commission’s webpage on Medical Device Coordination Group Working Groups.

New MDCG 2023-4 on Medical Device Software (MDSW) - Hardware combinations: guidance on MDSW intended to work in combination with hardware or hardware components (19/12/2023)

New MDCG 2023-4 on Medical Device Software (MDSW) - Hardware combinations: guidance on MDSW intended to work in combination with hardware or hardware components

The Medical Device Coordination Group (MDCG) endorsed a new guidance document, MDCG 2023-4, on Medical Device Software (MDSW) - Hardware combinations, as guidance on MDSW intended to work in combination with hardware or hardware components. For more, see the Commission’s webpage on Guidance.

Berlin session of the EU 2023 Chair of the Management Committee of the International Medical Device Regulators Forum (IMDRF) (19/12/2023)

Berlin session of the EU 2023 Chair of the Management Committee of the International Medical Device Regulators Forum (IMDRF)

Under the EU 2023 Chair of the Management Committee of the International Medical Device Regulators Forum (IMDRF), following the session in Brussels, Belgium held on 27-28 March 2023, a new session took place in Berlin, Germany on 25-26 September 2023 (see agenda). For more information, see EU chairs IMDRF in 2023 from the Commission’s webpage on International Cooperation, and the specific webpage IMDRF 2023 EU Chair.

Expert Panel advice on SARS-CoV-2 neutralising antibodies (19/12/2023)

Expert Panel advice on SARS-CoV-2 neutralising antibodies

The Medical Device Expert Panels issued advice on SARS-CoV-2 neutralising antibodies on request from the Medical Device Coordination Group (MDCG). For more, see the Commission’s webpage on Expert Panels. 

MDR and IVDR communication survey (19/12/2023)

MDR and IVDR communication survey

Designation of EU Reference Laboratories (EURLs) (19/12/2023)

Designation of EU Reference Laboratories (EURLs)

Resulting from the call for applications in 2022, the European Commission has designated five EU Reference Laboratories (EURLs) for certain class D in vitro diagnostic medical devices (IVDs). For more, see the Commission’s webpage on In Vitro Diagnostics - EU reference laboratories (EURLs). 

New Q&A document on transitional provisions for products without an intended medical purpose covered by Annex XVI to the MDR (19/12/2023)

New Q&A document on transitional provisions for products without an intended medical purpose covered by Annex XVI to the MDR

The European Commission issued a new questions and answers (Q&A) document to provide information on the transitional provisions for products without an intended medical purpose covered by Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR), for which common specifications have been set out in Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 as amended by Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023. For more, see the Commission’s webpage on Guidance.

New MDCG 2023-6 - Guidance on demonstration of equivalence for Annex XVI products (19/12/2023)

New MDCG 2023-6 - Guidance on demonstration of equivalence for Annex XVI products

The Medical Device Coordination Group (MDCG) endorsed MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products, as a guide for manufacturers and notified bodies for product without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR). For more, see the Commission’s webpage on Guidance.

Revision of MDCG 2021-6: questions and answers regarding clinical investigations (19/12/2023)

Revision of MDCG 2021-6: questions and answers regarding clinical investigations

The Medical Device Coordination Group (MDCG) endorsed MDCG 2021-6 Rev.1 Regulation (EU) 2017/745 – Questions & Answers. The revised version includes a number of new and updated questions and answers, and improvements in the Annexes. For more, see the Commission’s webpage on Guidance.

Updated manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (19/12/2023)

Updated manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices

The European Commission issued version 3 of the Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, as well as a Background note on the use of the Manual on borderline and classification for medical devices under the Directives. For more, see the Commission’s webpage on Guidance. 

New MDCG 2023-5 - Guidance on qualification and classification of Annex XVI products (19/12/2023)

New MDCG 2023-5 - Guidance on qualification and classification of Annex XVI products

The Medical Device Coordination Group (MDCG) endorsed MDCG 2023-5 Guidance on qualification and classification of Annex XVI products, as a guide for manufacturers and notified bodies for product without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 on medical devices (MDR). For more, see the Commission’s webpage on Guidance.