News

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.

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.

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Updated Timeline - Current planning for gradual roll out and modules’ functionality view

Information session on MDR/IVDR for international regulators – 4 July 2024

Become a pro member of the EU Health Policy Platform with these four training sessions and Q&A – register now and don’t miss out!

MDCG 2020-16 Rev.3 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - July 2024

Presentations and recording - Webinar on EU Cancer Mission: First project cluster policy webinar - Understanding Cancer (4 July 2024)

Factsheet - Cross-border Healthcare in 2022: Recent data on Member States’ implementation of Directive 2011/24/EU

Update - MDCG 2021-5 Rev.1 - Guidance on standardisation for medical devices - July 2024

The fifth International Day will focus on the need for financing to bolster efforts to reduce FLW, contribute to achieving climate goals and advancing the 2030 Agenda.

Summary of the 2023 (2022 data) annual reporting of serious adverse reactions and events for blood and blood components

Summary of the 2023 (2022 data) annual reporting of serious adverse reactions and events for tissues and cells

Presentations - Public Health Expert Group (19-20 June 2024)

With over 350 participants from 33 countries and over 50 expert speakers, Food Waste Free United and its partners look back on a successful conference ''Towards Halving Food Waste in Europe''.

The new coalition of Dutch manufacturers and supermarkets will collectively take extensive measures to clarify date marking on food products.

Presentations and recording - EUHPP Live Webinar: Info Session - Open Call for Proposals EU4H Annual Work Programme 2024 (26 June 2024)

Public consultation: Cooperation with the European Medicines Agency under the EU Health Technology Assessment Regulation

Final report - Best and promising practices on mental health (11-13 March 2024)

New guidance on the clinical evaluation of orphan medical devices published