MDCG 2020-16 rev.5 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
Revised guidance on IVDR classification rules for in vitro diagnostic devices published.
EC Public Health · EU-wideEC Public Health
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New Implementing Regulation sets out uniform requirements for conformity assessment and notified bodies
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 – uniform requirements for conformity assessment and notified bodies (Annex VII)
Implementing Regulation (EU) 2026/977 establishes uniform requirements for conformity assessment and notified bodies under the MDR/IVDR regime.
EC Public Health · EU-wideUpdate - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5
Version 5 of the EC manual on borderline and classification decisions under MDR and IVDR published.
EC Public Health · EU-wideMDCG 2021-24 rev.1 - Guidance on classification of medical devices (April 2026)
Updated guidance on medical device classification issued by the Medical Device Coordination Group.
EC Public Health · EU-wideMDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices
MDCG guidance on post-market surveillance obligations for medical devices and IVDs under MDR and IVDR.
EC Public Health · EU-wideMDCG Position Paper: UDI assignment between manufacturers and distributors
MDCG guidance on practical application of UDI assignment responsibilities under MDR and IVDR.
EC Public Health · EU-wideHealth Technology Assessment: Commission adopts rules for joint clinical assessments of medical devices and in vitro diagnostic medical devices
Commission adopts rules enabling joint clinical assessments of medical devices and IVDs under the HTA Regulation.
EC Public Health · EU-wideGeneral Principles on the use of Artificial Intelligence in the preparation of the JCA dossier
EC Public Health publishes general principles governing AI use in preparing Joint Clinical Assessment dossiers.
EC Public Health · EU-wideEU HTA Regulation: new eligibility tool and updated guidance for early information for joint clinical assessments
Updated guidance and eligibility tool published to support early information provision for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-widePublic Consultation - TEHDAS2 (Second Joint Action Towards the European Health Data Space)
European Commission invites input on the second joint action implementing the European Health Data Space framework.
EC Public Health · EU-wideUpdated Questions and Answers on general methodological and procedural issues for joint clinical assessments
Updated guidance on methodology and procedure for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideQuestions and Answers on general methodological and procedural issues for joint clinical assessments
Guidance clarifying methodological and procedural requirements for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideCOMBINE Project 2: Sponsors' guide on safety reporting in combined studies
Publication of guidance for sponsors on safety reporting procedures in combined clinical trials.
EC Public Health · EU-widePublic consultation: Health hazards and risks of brain stimulators for non-medical purposes
EC invites input on health hazards and risks posed by brain stimulation devices used outside medical contexts.
EC Public Health · EU-wideCommission establishes the European Health Data Space Stakeholder Forum and Community
European Commission invites organisations to join the EHDS Stakeholder Forum and Community to support implementation of the European Health Data Space.
EC Public Health · EU-widePublication of videos from the third EMDN training
The 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-wideMonitoring of Notified Bodies: 2025 MDR and IVDR annual reports
Member States' summaries of annual monitoring and on-site assessment reports for notified bodies under MDR and IVDR are now published.
EC Public Health · EU-wideUpdated list of notified bodies' standard fees
News 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-wideJune 2026 updated information on applications for designation as a notified body
News 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-wideUpdate - Notified bodies survey on certifications and applications
News 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-wideNotified bodies survey on certifications and applications
News 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-wideHTA Regulation – Commission selects first medical devices for joint clinical assessment
The European Commission has selected the first medical devices for joint clinical assessment under the HTA Regulation.
EC Public Health · EU-wideUpdated – Submission request template for medical devices
News announcement 16 July 2026 Updated – Submission request template for medical devices 1 min read
EC Public Health · EU-wideNew publication of harmonised standards under the medical devices Regulation – April 2026
News 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-wideNew publications of harmonised standards under the medical devices Regulations – January 2026
News 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-wideNew publication of Harmonised standards under the medical devices Regulations – October 2025
News 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-wideSCHEER Working Group Meeting on Brain Stimulators – Minutes, 29 September 2026
SCHEER - Minutes of the Working Group Meeting on Brain stimulators of 29 September 2026
EC Public Health · EU-wideEuropean Biotech Clusters: Connect. Collaborate. Scale — Turning the Biotech Act's ambition into action
Registration - European Biotech Clusters: Connect. Collaborate. Scale: Turning the Biotech Act’s ambition into action (19 November 2026)
EC Public Health · EU-wideCommission boosts Ebola response with €2.5 million of rapid diagnostic tests
European Commission procures €2.5 million in rapid molecular diagnostic tests for Bundibugyo Ebola outbreak response in DRC.
EC Public Health · EU-wideHealth Technology Assessment – Member State Coordination Group adopts guiding principles on data transparency
The HTA Member State Coordination Group has adopted guiding principles on data transparency.
EC Public Health · EU-wideUpdate - Member States-specific national requirements for clinical investigations and performance studies
News 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-wideHealth Technology Assessment: New opportunity to apply for Joint Scientific Consultations
News 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-wideUpdated rolling plan - Implementation of the Regulation on health technology assessment (December 2025)
News 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-wideHealth Technology Assessment – 2026 Work Programme adopted
News 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 digital health and EHDS implementation
EU4Health 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
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