EU-wide health regulation is set by the European Commission, the 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.
Commission Delegated Regulation (EU) 2026/1451 amending Regulation (EU) 2017/745 on medical devices enters into force on 19 July 2026, expanding requirements for implantable and Class III devices.
Latvia ZVA (State Agency of Medicines) · LatviaPublication of MDCG guidance on the allocation of unique device identification (UDI) responsibilities between manufacturers and distributors.
Czechia SUKL · Czech RepublicBulletin implementing EU Regulation 2026/977 establishing uniform quality management and conformity assessment procedure requirements for medical devices.
AEMPS (Spanish Medicine Agency) · SpainDelegated acts establishing criteria and procedures for well-established technologies under the MDR have been published.
EC Medical Devices · EU-wideHigh-risk AI systems in medical devices must meet AI Act requirements on risk management, data governance, documentation, logging, transparency and oversight, with penalties up to €15M or 3% of global turnover.
EC AI Act & Regulation · EU-wideEUDAMED core modules (economic actor, UDI/device, certificate, market surveillance) become mandatory 6 months after Official Journal publication; national registrations replaced.
EUDAMED · EU-wideManufacturers must report all adverse events and post-market surveillance data through EUDAMED Vigilance module, replacing national systems.
EUDAMED · EU-wideThe EHDS is the EU's first sector-specific common data space, establishing a framework for health data access and use across member states.
European Health Data Space · EU-wideEHDS Regulation becomes law 20 days after publication in the EU Official Journal.
European Commission · EU-wideThe European Commission's AI Office, national competent authorities, and the European Data Protection Supervisor share enforcement of the AI Act across different AI system categories.
EU AI Act Implementation · EU-wideFrom 2 August 2026, AI Act enforcement begins and transparency rules require AI systems to disclose interaction with users and label AI-generated or altered content.
EU AI Act Implementation · EU-wideGuidelines clarify AI Act transparency obligations for interactive AI systems and AI-generated content, effective 2 August 2026.
EU AI Act Implementation · EU-wideCommission publishes a Code of Practice establishing requirements for marking and labelling of AI-generated content.
EC AI Act & Regulation · EU-wideCommission policy to increase AI experts and literacy among workers and the public; Article 4 AI Act obligations on providers and deployers entered into force February 2025, amended July 2026.
EU AI Act Implementation · EU-wideAn 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-wideImplementing regulation establishing uniform quality management and procedural requirements for notified bodies conducting conformity assessment under MDR and IVDR.
EUR-Lex Official Journal · EU-wideNews announcement 26 March 2026 Frequently Asked Questions on the European Health Data Space 1 min read
European Health Data Space · EU-wideCross-border exchange of patient summaries and ePrescriptions becomes mandatory for all EU Member States.
European Commission · 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-wideImplementing regulation establishing the governance structure and operational procedures for the European Health Data Space Board.
EUR-Lex Official Journal · EU-wideAmendment to MDR exemption list for implantable and Class III devices from clinical investigation obligations.
EUR-Lex Official Journal · EU-wideHarmonised standards will support implementation of the AI Act's high-risk AI system requirements and pre-market compliance obligations.
EC AI Act & Regulation · 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-wideEuropean Commission updates the manual on borderline and classification decisions for medical devices and in-vitro diagnostics.
EC Medical Devices · EU-wideArticle 5 prohibitions on biometric categorization, social scoring, and emotion recognition in workplace and education settings enter into force.
European Commission · EU-wideFAQ clarifying how MDR, IVDR and the AI Act interact in the regulation of AI-enabled medical devices and diagnostics.
EC Medical Devices · EU-wideMyHealth@EU infrastructure for primary use becomes mandatory; cross-border Patient Summaries and ePrescriptions/eDispensations exchange required; full EHR vendor compliance deadline March 2029.
European Health Data Space · EU-wideEHDS infrastructure operational for patient care data exchange and research access; providers and EHR manufacturers must comply with interoperability requirements; fines up to €20M or 4% of turnover.
European Health Data Space · EU-wideAEMPS establishes a procedure for healthcare centres to submit prior notifications of in-house IVD manufacture pending the specific electronic application.
AEMPS (Spanish Medicine Agency) · SpainEC 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-wideThe European AI Office and the national market surveillance authorities are responsible for
EU AI Act Implementation · EU-wideEDPB adopts final guidelines on anonymisation, web scraping for generative AI, and personal data processing through blockchain technologies.
EDPB (European Data Protection Board) · EU-wideEU Action Plan addresses risks and opportunities of advanced AI models for cybersecurity, bringing together Member States, industry and EU organisations.
EU AI Act Implementation · EU-wideThe Commission invites stakeholder input on draft guidelines for classifying high-risk AI systems under the AI Act.
EC AI Act & Regulation · EU-wideEuropean Commission invites input on the second joint action implementing the European Health Data Space framework.
EC Public Health · EU-wideCommission Delegated Regulation (EU) 2025/788 amends Delegated Regulation (EU) 2023/2197 regarding the application date.
EC Medical Devices · EU-wideDirective clarifies 'product' definition to include digital manufacturing files and software, modernizing liability framework for AI-enabled devices and SaMD.
EUR-Lex Official Journal · EU-wideFinal deadline to lodge Notified Body applications for Class D IVDs and IVDD-certified devices to benefit from extended transition period ending December 2027.
EC Medical Devices · EU-wideClass D IVDs and IVDD-certified devices can no longer be placed on EU market under the old IVDD regime; full IVDR certification is now required.
EC Medical Devices · EU-wideFinal deadline for Class III and Class IIb implantable devices to transition from MDD/AIMDD to MDR; no further extensions.
EC Medical Devices · EU-wideEuropean Commission publishes draft Code of Practice establishing requirements for marking and labelling of AI-generated content under the AI Act.
EC AI Act & Regulation · EU-wideThe privacy code of conduct on mobile health apps aims to promote trust among users and provide a
EC Digital Health · EU-wideEuropean Commission invites input on draft guidelines implementing AI Act transparency requirements.
EC AI Act & Regulation · EU-wideCompilation of Joint Clinical Assessment reports, procedural guidance on AI use in HTA dossiers, data transparency principles, and methodological FAQs for medical devices and IVDs.
EU HTA Regulation Implementation · EU-wideCommission seeks stakeholder input on simplifying EU rules governing data, cybersecurity and AI in a forthcoming Digital Omnibus legislative package.
EU AI Act Implementation · EU-wide