Establishes interoperable cross-border identification and authentication mechanism for natural persons, health professionals and healthcare providers for cross-border personal electronic health data exchange.
EUR-Lex Official Journal · EU-wideStudy examines AI technologies in healthcare, EU legal frameworks for data reuse in medical AI development, and presents policy recommendations to address implementation challenges.
European Parliament - SANT Subcommittee (Public Health) · EU-wideBriefing on AI use in protein, peptide and nucleic acid design across biopharmaceutical research, industrial biotechnology and vaccine development, with regulatory implications for the EU.
European Parliament - SANT Subcommittee (Public Health) · EU-wideEstablishes minimum metadata elements and characteristics that health data holders must provide for dataset descriptions enabling secondary use of electronic health data under EHDS.
EUR-Lex Official Journal · EU-wideRevised guidance on IVDR classification rules for in vitro diagnostic devices published.
EC Public Health · EU-widePublication 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) · SpainHigh-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 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-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-wideCommission 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) · LatviaAn 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-wideDelegated acts establishing criteria and procedures for well-established technologies under the MDR have been published.
EC Medical Devices · 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-wideMDCG guidance on post-market surveillance obligations for medical devices and IVDs under MDR and IVDR.
EC Public Health · EU-wideMDCG guidance on practical application of UDI assignment responsibilities under MDR and IVDR.
EC Public Health · 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-wideFAQ clarifying how MDR, IVDR and the AI Act interact in the regulation of AI-enabled medical devices and diagnostics.
EC Medical Devices · 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) · SpainEDPB adopts guidelines on administrative fines under GDPR and on interplay between Digital Service Act and GDPR.
EDPB (European Data Protection Board) · 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-wideHarmonised standards will offer legal certainty under the AI Act, support innovation, and position
EC AI Act & Regulation · EU-wideThe Commission invites stakeholder input on draft guidelines for classifying high-risk AI systems under the AI Act.
EC AI Act & Regulation · EU-wideCross-border exchange of patient summaries and ePrescriptions becomes mandatory for all EU Member States.
European Commission · 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-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-wideEuropean Commission invites input on draft guidelines implementing AI Act transparency requirements.
EC AI Act & Regulation · 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 to support early information provision for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideEDPB adopts guidance on privacy and surveillance risks posed by smart glasses, including video recording and evidence administration.
EDPB (European Data Protection Board) · EU-wide