ELSIBI – Ethical, Legal and Social Implications of Biomedical Innovations – Implications Ethiques, Juridiques et Sociales des Innovations Biomédicales

Commission’s science advisors recommend ways of strengthening One Health governance in the EU

More support to research, innovation and education on One Health – the approach recognising that human, animal and environmental health are interconnected – as well as breaking down silos for better coherence of EU policies in this area. These are among the independent policy recommendations to shape One Health governance in the European Union, released today by the Commission’s Scientific Advice Mechanism (SAM).

Read the news article published by Directorate-General for Research and Innovation on 15 November 2024.

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Commission launches new platform for cross-border medical discussions on rare diseases

The Commission has launched a new IT platform for cross-border medical discussions on rare diseases. The Clinical Patient Management System 2.0 (CPMS 2.0) will support the European Reference Networks in improving the diagnosis and treatment...

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Video recording – EUHPP Live Webinar: European Reference Network evaluation: the way forward (4 December 2024)

This webinar presented the European Reference Network evaluation results report which was published on 29 November 2024. The report summarizes the results of a comprehensive evaluation of European Reference Networks and its members, five years after...

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New Health Union Fellowship launched today!

The new Health Union Fellowship has been launched today, under the motto “Health Unites Us”. The Fellowship programme is a stepping stone of the European Health Union, designed to promote learning, knowledge exchange and collaboration...

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Second HERA Invest agreement signed to advance therapies against antimicrobial resistance

HERA has today signed the second agreement under HERA Invest, its pioneering financial mechanism designed to support the research and development of medical countermeasures (MCMs) and technologies to address priority cross-border health threats. Read the news...

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

National authorities in Member States have endorsed a new strategy for the COMBINE programme, a cross-sector initiative to streamline combined studies of medicines and medical devices, including diagnostics. The COMBINE programme will be rolled out...

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Factsheet for healthcare professionals and health institutions

In April 2017, the European Parliament and the Council adopted the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. These two Regulations aim to create a robust, transparent,...

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IRDiRC Position Statement – World Health Assembly Resolution on Rare Diseases

The International Rare Disease Consortium (IRDiRC) proudly supports the World Health Assembly resolution on Rare Diseases. This is a crucial step towards addressing global disparities in care, research, and treatment for people living with rare diseases. Read the...

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EU4Health call for tenders: translation and validation of the European medical device nomenclature and the International medical device regulators forum terminologies

HaDEA has published the call for tenders HADEA/2024/OP/0026 – Service contract to translate and validate the European medical device nomenclature (EMDN) and the International medical device regulators forum adverse events terminologies in official EU languages. This...

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MDCG 2024-15 – Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)

Article 77(5) Medical Devices Regulation requires that the sponsor submits to the Member States in which a clinical investigation was conducted a clinical investigation report within one year of the end of the clinical investigation...

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MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical device

Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices (as per Article 10a of Regulation (EU) 2024/1860 amending Regulation (EU) 2017/745 and Regulation (EU)...

Commission’s science advisors recommend ways of strengthening One Health governance in the EU

Commission launches new platform for cross-border medical discussions on rare diseases

Video recording – EUHPP Live Webinar: European Reference Network evaluation: the way forward (4 December 2024)

New Health Union Fellowship launched today!

Second HERA Invest agreement signed to advance therapies against antimicrobial resistance

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

Factsheet for healthcare professionals and health institutions

IRDiRC Position Statement – World Health Assembly Resolution on Rare Diseases

EU4Health call for tenders: translation and validation of the European medical device nomenclature and the International medical device regulators forum terminologies

MDCG 2024-15 – Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)

MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical device

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