MDCG Opinion 2026-5 on UDI assignment between manufacturers and distributors
Publication of MDCG guidance on the allocation of unique device identification (UDI) responsibilities between manufacturers and distributors.
Czechia SUKL · Czech Republic
Jurisdiction
EU-wide
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.
Regulation
Category
Type · Breadth
Date
The enforcement framework of the AI Act
The 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-wideAI Act enforcement and transparency requirements begin 2 August 2026
From 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-wideAI talent, skills and literacy
Commission 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-widePublished amendments to the regulation on medical devices
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) · LatviaBulletin on Medical Devices. April–June 2026
Bulletin implementing EU Regulation 2026/977 establishing uniform quality management and conformity assessment procedure requirements for medical devices.
AEMPS (Spanish Medicine Agency) · SpainMedical Devices: Delegated acts on well-established technologies published
Delegated acts establishing criteria and procedures for well-established technologies under the MDR have been published.
EC Medical Devices · EU-wideAI Act for Medical Devices
High-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 Become Mandatory
EUDAMED core modules (economic actor, UDI/device, certificate, market surveillance) become mandatory 6 months after Official Journal publication; national registrations replaced.
EUDAMED · EU-wideEUDAMED Vigilance Module Mandatory
Manufacturers must report all adverse events and post-market surveillance data through EUDAMED Vigilance module, replacing national systems.
EUDAMED · EU-wideEuropean Health Data Space (EHDS) Regulation: overview
The 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-wideEuropean Health Data Space Regulation: entry into force
EHDS Regulation becomes law 20 days after publication in the EU Official Journal.
European Commission · EU-wideCommission guidelines on transparency obligations for providers and deployers of certain AI systems
Guidelines clarify AI Act transparency obligations for interactive AI systems and AI-generated content, effective 2 August 2026.
EU AI Act Implementation · EU-wideCommission publishes Code of Practice on marking and labelling AI-generated content
Commission publishes a Code of Practice establishing requirements for marking and labelling of AI-generated content.
EC AI Act & Regulation · EU-wideNew 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-wideCommission Implementing Regulation (EU) 2026/977 laying down uniform quality management and procedural requirements for notified body conformity assessment activities under MDR and IVDR
Implementing regulation establishing uniform quality management and procedural requirements for notified bodies conducting conformity assessment under MDR and IVDR.
EUR-Lex Official Journal · EU-wideFrequently 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 Space · EU-wideMyHealth@EU Patient Summaries and ePrescriptions Mandatory
Cross-border exchange of patient summaries and ePrescriptions becomes mandatory for all EU Member States.
European Commission · 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-wideCommission Implementing Regulation (EU) 2026/771 establishing the European Health Data Space Board
Implementing regulation establishing the governance structure and operational procedures for the European Health Data Space Board.
EUR-Lex Official Journal · EU-wideCommission Delegated Regulation (EU) 2026/1451 amending MDR as regards exemptions from clinical investigation for implantable and Class III devices
Amendment to MDR exemption list for implantable and Class III devices from clinical investigation obligations.
EUR-Lex Official Journal · EU-wideStandardisation of the AI Act
Harmonised 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 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: Management of SSCP in EUDAMED after mandatory use
MDCG guidance on managing Summary of Safety and Clinical Performance in EUDAMED following mandatory use implementation.
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-wideUpdate - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - September 2025
European Commission updates the manual on borderline and classification decisions for medical devices and in-vitro diagnostics.
EC Medical Devices · EU-wideEU AI Act: Prohibited AI Systems Ban under Article 5
Article 5 prohibitions on biometric categorization, social scoring, and emotion recognition in workplace and education settings enter into force.
European Commission · EU-wideMDCG 2025-6 – FAQ on Interplay between the Medical Devices Regulation, In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act
FAQ clarifying how MDR, IVDR and the AI Act interact in the regulation of AI-enabled medical devices and diagnostics.
EC Medical Devices · EU-wideEHDS Primary Use Infrastructure Operational
MyHealth@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 Full Implementation (Primary and Secondary Use)
EHDS 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 enables procedure for prior notification of in-house manufacture of in vitro diagnostic devices
AEMPS establishes a procedure for healthcare centres to submit prior notifications of in-house IVD manufacture pending the specific electronic application.
AEMPS (Spanish Medicine Agency) · SpainGeneral 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 for early information submission in joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideGovernance and enforcement of the AI Act
The European AI Office and the national market surveillance authorities are responsible for
EU AI Act Implementation · EU-wideEDPB guidelines on anonymisation, web scraping for generative AI, and blockchain data processing
EDPB adopts final guidelines on anonymisation, web scraping for generative AI, and personal data processing through blockchain technologies.
EDPB (European Data Protection Board) · EU-wideCommission presents EU Action Plan on Cybersecurity and Artificial Intelligence
EU 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-wideCommission seeks feedback on draft guidelines for classification of high-risk artificial intelligence systems
The Commission invites stakeholder input on draft guidelines for classifying high-risk AI systems under the AI Act.
EC AI Act & Regulation · 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-wideCommission Delegated Regulation (EU) 2025/788 amending Delegated Regulation (EU) 2023/2197 as regards the date of application
Commission Delegated Regulation (EU) 2025/788 amends Delegated Regulation (EU) 2023/2197 regarding the application date.
EC Medical Devices · EU-wideEU Products Liability Directive (EU) 2024/2853 – National Transposition
Directive clarifies 'product' definition to include digital manufacturing files and software, modernizing liability framework for AI-enabled devices and SaMD.
EUR-Lex Official Journal · EU-wideIVDR Class D/IVDD Devices - Application Deadline
Final 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-wideIVDR Class D/IVDD Final Market Placement
Class 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-wideMDR High-Risk Devices Final Transition Deadline
Final deadline for Class III and Class IIb implantable devices to transition from MDD/AIMDD to MDR; no further extensions.
EC Medical Devices · EU-wideCommission publishes first draft of Code of Practice on marking and labelling of AI-generated content
European 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 action plan to protect the health sector from cyberattacks
EU action plan announced to strengthen cybersecurity of hospitals and healthcare providers.
EC Digital Health · EU-widePrivacy code of conduct on mobile health apps
The privacy code of conduct on mobile health apps aims to promote trust among users and provide a
EC Digital Health · EU-wideCommission opens consultation on draft guidelines for AI transparency obligations
European Commission invites input on draft guidelines implementing AI Act transparency requirements.
EC AI Act & Regulation · EU-wideCommission launches consultation to develop guidelines and Code of Practice on transparent AI systems
Commission invites input on guidelines and Code of Practice for transparent AI systems under the AI Act.
EU AI Act Implementation · EU-wide
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