MEDICAL DEVICES NEWS

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.

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.

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.

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.

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.

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.

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’

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.

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’

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.

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’

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’

In July 2024, the Medical Device Coordination Group (MDCG) endorsed the revised version of the documentMDCG 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’

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’

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’

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

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.

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.

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.

‘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.

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 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’.

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.

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.

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.

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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