An Implementing Regulation establishes uniform requirements for conformity assessment and notified bodies under the medical device framework.
EC Public Health · EU-wideImplementing Regulation (EU) 2026/977 establishes uniform requirements for conformity assessment and notified bodies under the MDR/IVDR regime.
EC Public Health · EU-wideVersion 5 of the EC manual on borderline and classification decisions under MDR and IVDR published.
EC Public Health · EU-wideUpdated guidance on medical device classification issued by the Medical Device Coordination Group.
EC Public Health · EU-wideMDCG guidance on post-market surveillance obligations for medical devices and IVDs under MDR and IVDR.
EC Public Health · EU-wideMDCG guidance on managing Summary of Safety and Clinical Performance in EUDAMED following mandatory use implementation.
EC Public Health · EU-wideCommission adopts rules enabling joint clinical assessments of medical devices and IVDs under the HTA Regulation.
EC Public Health · EU-wideEC Public Health publishes general principles governing AI use in preparing Joint Clinical Assessment dossiers.
EC Public Health · EU-wideUpdated guidance and eligibility tool published for early information submission in joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideEuropean Commission invites input on the second joint action implementing the European Health Data Space framework.
EC Public Health · EU-wideUpdated guidance on methodology and procedure for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideGuidance clarifying methodological and procedural requirements for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideThe European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. Founded on pre-established criteria and requirements and base...
EC Public Health · EU-wideEC invites input on health hazards and risks posed by brain stimulation devices used outside medical contexts.
EC Public Health · EU-wideMember States' summaries of annual monitoring and on-site assessment reports for notified bodies under MDR and IVDR are now published.
EC Public Health · EU-wideNews announcement 13 July 2026 Updated list of notified bodies’ standard fees Updated list of notified bodies’ standard fees 1 min read
EC Public Health · EU-wideNews announcement 1 July 2026 June 2026 updated information on the applications for designation as a notified body - Overview of CABs/NBs at each stage of the designation process June 2026 updated information on the a...
EC Public Health · EU-wideNews announcement 16 July 2026 Updated – Submission request template for medical devices 1 min read
EC Public Health · EU-wideNews announcement 8 May 2026 Update - Notified bodies survey on certifications and applications (8 May 2026) Update - Notified bodies survey on certifications and applications (8 May 2026) 1 min read
EC Public Health · EU-wideNews announcement 26 March 2026 Notified bodies survey on certifications and applications Notified bodies survey on certifications and applications 1 min read
EC Public Health · EU-wideNews announcement 7 April 2026 New publication of harmonised standards under the medical devices Regulation – April 2026 New publication of harmonised standards under the medical devices Regulation – April 2026 1 min ...
EC Public Health · EU-wideNews announcement 30 January 2026 New publications of harmonised standards under the medical devices Regulations – January 2026 New publications of harmonised standards under the medical devices Regulations – January ...
EC Public Health · EU-wideNews announcement 20 October 2025 New publication of Harmonised standards under the medical devices Regulations – October 2025 New publication of Harmonised standards under the medical devices Regulations – October 20...
EC Public Health · EU-wideEuropean Commission procures €2.5 million in rapid molecular diagnostic tests for Bundibugyo Ebola outbreak response in DRC.
EC Public Health · EU-wideThe HTA Member State Coordination Group has adopted guiding principles on data transparency.
EC Public Health · EU-wideNews announcement 21 April 2026 Update - Member States-specific national requirements for clinical investigations and performance studies Update - Member States-specific national requirements for clinical investigatio...
EC Public Health · EU-wideNews announcement 7 January 2026 Health Technology Assessment: New opportunity to apply for Joint Scientific Consultations Health Technology Assessment: New opportunity to apply for Joint Scientific Consultations 1 mi...
EC Public Health · EU-wideNews announcement 8 December 2025 Updated rolling plan - Implementation of the Regulation on health technology assessment (December 2025) Updated rolling plan - Implementation of the Regulation on health technology as...
EC Public Health · EU-wideNews announcement 2 December 2025 Health Technology Assessment – 2026 Work Programme adopted Health Technology Assessment – 2026 Work Programme adopted 1 min read
EC Public Health · EU-wideEU4Health call for tenders: Administrative and secretarial support for the implementation of initiatives on digital health and the European Health Data Space (EHDS)
EC Public Health · EU-wide