Jurisdiction
EU-wide
EU-wide health regulation is set by the European Commission, the European Parliament and Council, and agencies such as the European Medicines Agency. It applies across all member states, either directly through regulations like the MDR, IVDR, Clinical Trials Regulation, and EU AI Act, or through directives that member states transpose into national law. This page collects the EU-wide updates HealthSignal tracks across medicines, medical devices, digital health, clinical trials, and health data, from official public sources only.
Regulation
Category
Impact
Date
PMS Q&A Clinic on Product User Interface (PUI) and Application Programming Interface (API) – July 2026
23 Jul 2026 PMS Q&A Clinic on Product User Interface (PUI) and Application Programming Interface (API) – July 2026 Online Start date: 23 July 2026, 09:30 (CEST) End date: 23 July 2026, 10:30 (CEST)
EMA - European Medicines AgencyAMENDMENTS 2802 - 2985 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) - PE790.953v01-00
AMENDMENTS 2802 - 2985 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2...
European Parliament - SANT Subcommittee (Public Health)AMENDMENTS 2522 - 2801 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) - PE790.939v01-00
AMENDMENTS 2522 - 2801 - Draft report Establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2...
European Parliament - SANT Subcommittee (Public Health)General Principles on the use of Artificial Intelligence in the preparation of the JCA dossier
News announcement 16 July 2026 General Principles on the use of Artificial Intelligence in the preparation of the JCA dossier 1 min read
EC Public HealthUpdated – Submission request template for medical devices
News announcement 16 July 2026 Updated – Submission request template for medical devices 1 min read
EC Public HealthFlash report published: Member State Coordination Group meeting on 16 July 2026
News announcement 16 July 2026 Flash report published: Member State Coordination Group meeting on 16 July 2026 Flash report published: Member State Coordination Group meeting on 16 July 2026 1 min read
EC Public HealthDRAFT REPORT on the proposal for a Directive of the European Parliament and of the Council amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and the processing of organs - PE789.094v01-00
DRAFT REPORT on the proposal for a Directive of the European Parliament and of the Council amending Directives 2001/18/EC and 2010/53/EU as regards the placing on the market of genetically modified micro-organisms and...
European Parliament - SANT Subcommittee (Public Health)Highlights - Medical Devices Regulation - consideration of draft report - Committee on Public Health
<div style="float: left; margin: 0px 5px 0px 0px;"><img alt="Medical ventilator being monitored by anaesthetist" src="https://www.europarl.europa.eu/resources/library/images/20230508PHT85501/20230508PHT85501-ms.jpg" t...
European Parliament - SANT Subcommittee (Public Health)DRAFT REPORT with recommendations to the Commission on Modernised rules for patients’ rights in cross-border healthcare - PE790.010v03-00
DRAFT REPORT with recommendations to the Commission on Modernised rules for patients’ rights in cross-border healthcare<br />Committee on Public Health<br />Giorgos Georgiou<br /> <br />Source : <a href="https://www.e...
European Parliament - SANT Subcommittee (Public Health)Updated 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 HealthQuestions and answers (version 22) - Safety features for medicinal products for human use
News announcement 10 July 2026 Questions and answers (version 22) - Safety features for medicinal products for human use 1 min read
EC Public HealthSummary conclusions - Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi (10 June 2026)
News announcement 8 July 2026 Summary conclusions - Implementation dialogue on the European Health Data Space Regulation with Commissioner Olivér Várhelyi (10 June 2026) 1 min read
European Health Data SpaceUpdated - List of joint clinical assessments
News announcement 8 July 2026 Updated - List of joint clinical assessments 1 min read
EU HTA Regulation ImplementationCommission presents EU Action Plan on Cybersecurity and Artificial Intelligence
PRESS RELEASE | 07 July 2026 Commission presents EU Action Plan on Cybersecurity and Artificial Intelligence
EU AI Act ImplementationWhy do we need rules on AI?
The AI Act is the first-ever legal framework on AI, which addresses the risks of AI and positions Europe to play a leading role globally.
EU AI Act ImplementationJune 2026 updated information on the applications for designation as a notified body - Overview of CABs/NBs at each stage of the designation process
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 HealthMedical Devices: Delegated acts on well-established technologies published
News announcement 29 June 2026 Medical Devices: Delegated acts on well-established technologies published 1 min read
EC Medical DevicesEudralex Volume 4: Reference and Retention Samples (revised, applicable as of 24 September 2026)
News announcement 24 June 2026 Eudralex Volume 4: Reference and Retention Samples (revised, applicable as of 24 September 2026) 1 min read
EC Pharmaceutical StrategyFlash report published: Member State Coordination Group meeting on 22 June 2026
News announcement 24 June 2026 Flash report published: Member State Coordination Group meeting on 22 June 2026 Flash report published: Member State Coordination Group meeting on 22 June 2026 1 min read
EC Public HealthCommission publishes Code of Practice on marking and labelling AI-generated content
PRESS RELEASE | 10 June 2026 Commission publishes Code of Practice on marking and labelling AI-generated content
EC AI Act & RegulationUpdated - List of joint clinical assessments
News announcement 9 June 2026 Updated - List of joint clinical assessments Updated - List of joint clinical assessments 1 min read
EC Public HealthJoint clinical assessment report published on tovorafenib (Ojemda)
News announcement 9 June 2026 Joint clinical assessment report published on tovorafenib (Ojemda) Joint clinical assessment report published on tovorafenib (Ojemda) 1 min read
EC Public HealthEuropean Semester 2026: the Commission proposes health-related recommendations to 14 Member States
News announcement 3 June 2026 European Semester 2026: the Commission proposes health-related recommendations to 14 Member States European Semester 2026: the Commission proposes health-related recommendations to 14 Mem...
EC Public HealthAI Act enforcement gets independent expert support
PRESS RELEASE | 01 June 2026 AI Act enforcement gets independent expert support
EC AI Act & RegulationCommission publishes analysis underpinning the Biotech Act proposals
News announcement 27 May 2026 Commission publishes analysis underpinning the Biotech Act proposals Commission publishes analysis underpinning the Biotech Act proposals 1 min read
EC Public HealthCommission welcomes political agreement on Critical Medicines Act
News announcement 20 May 2026 Commission welcomes political agreement on Critical Medicines Act Commission welcomes political agreement on Critical Medicines Act 1 min read
EC Public HealthCommission seeks feedback on the draft guidelines for the classification of high-risk artificial intelligence systems
PRESS RELEASE | 19 May 2026 Commission seeks feedback on the draft guidelines for the classification of high-risk artificial intelligence systems
EC AI Act & RegulationHealth Technology Assessment – Member State Coordination Group adopts guiding principles on data transparency
News announcement 18 May 2026 Health Technology Assessment – Member State Coordination Group adopts guiding principles on data transparency Health Technology Assessment – Member State Coordination Group adopts guiding...
EC Public HealthNew Implementing Regulation sets out uniform requirements for conformity assessment and notified bodies
News announcement 18 May 2026 New Implementing Regulation sets out uniform requirements for conformity assessment and notified bodies New Implementing Regulation sets out uniform requirements for conformity assessment...
EC Public HealthUpdated - Questions and Answers on general methodological and procedural issues for joint clinical assessments
News announcement 18 May 2026 Updated - Questions and Answers on general methodological and procedural issues for joint clinical assessments Updated - Questions and Answers on general methodological and procedural iss...
EC Public HealthData on cross-border patient healthcare following Directive 2011/24/EU for reference year 2024
News announcement 12 May 2026 Data on cross-border patient healthcare following Directive 2011/24/EU for reference year 2024 Data on cross-border patient healthcare following Directive 2011/24/EU for reference year 20...
EC Public HealthACT EU workplan for 2026-2027 & updated objectives published
News article 8 May 2026 ACT EU workplan for 2026-2027 & updated objectives published 1 min read
ACT EU - Accelerating Clinical TrialsUpdate - Notified bodies survey on certifications and applications (8 May 2026)
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 HealthCommission opens consultation on draft guidelines for AI transparency obligations
PRESS RELEASE | 08 May 2026 Commission opens consultation on draft guidelines for AI transparency obligations
EC AI Act & RegulationEU agrees to simplify AI rules to boost innovation and ban ‘nudification' apps to protect citizens
PRESS RELEASE | 07 May 2026 EU agrees to simplify AI rules to boost innovation and ban ‘nudification' apps to protect citizens
EC AI Act & RegulationImplementing Regulation (EU) 2026/977 – uniform requirements for conformity assessment and notified bodies (Annex VII)
News announcement 5 May 2026 Implementing Regulation (EU) 2026/977 – uniform requirements for conformity assessment and notified bodies (Annex VII) Implementing Regulation (EU) 2026/977 – uniform requirements for conf...
EC Public HealthUpdate - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5
News announcement 22 April 2026 Update - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 Update - Manual on borderline and classification under Regulations (EU) 2017/745 and 201...
EC Public HealthUpdate - 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 HealthUpdate - MDCG 2021-24 rev.1 - Guidance on classification of medical devices (April 2026)
News announcement 20 April 2026 Update - MDCG 2021-24 rev.1 - Guidance on classification of medical devices (April 2026) Update - MDCG 2021-24 rev.1 - Guidance on classification of medical devices (April 2026) 1 min read
EC Public HealthNew 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 HealthNotified 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 HealthFrequently Asked Questions on the European Health Data Space
News announcement 26 March 2026 Frequently Asked Questions on the European Health Data Space 1 min read
European Health Data SpaceOverview of recommendations on preparedness and response to serious cross-border threats to health, pursuant to Article 7(2) of Regulation (EU) 2022/2371
News announcement 6 March 2026 Overview of recommendations on preparedness and response to serious cross-border threats to health, pursuant to Article 7(2) of Regulation (EU) 2022/2371 Overview of recommendations on p...
EC Public HealthConsultation of new guidance on the conduct of clinical trials during public health emergencies in the EU
News announcement 5 March 2026 Consultation of new guidance on the conduct of clinical trials during public health emergencies in the EU Consultation of new guidance on the conduct of clinical trials during public hea...
EC Public HealthNew guidance on the conduct of clinical trials during public health emergencies in the EU
News article 5 March 2026 New guidance on the conduct of clinical trials during public health emergencies in the EU 1 min read
ACT EU - Accelerating Clinical TrialsEvaluation of the Biocidal Products Regulation: last days to contribute to the Call for Evidence and public consultation
News announcement 27 February 2026 Evaluation of the Biocidal Products Regulation: last days to contribute to the Call for Evidence and public consultation Evaluation of the Biocidal Products Regulation: last days to ...
EC Public HealthFlash report - Member State Coordination Group on HTA (HTACG) (12 February 2026)
News announcement 16 February 2026 Flash report - Member State Coordination Group on HTA (HTACG) (12 February 2026) Flash report - Member State Coordination Group on HTA (HTACG) (12 February 2026) 1 min read
EC Public HealthSCCS - Scientific Advice on the safety of Thiomersal and Phenylmercuric salts as preservatives in cosmetic products
News announcement 10 February 2026 SCCS - Scientific Advice on the safety of Thiomersal and Phenylmercuric salts as preservatives in cosmetic products SCCS - Scientific Advice on the safety of Thiomersal and Phenylmer...
EC Public HealthNew 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
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