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