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Regulatory News
Medical device regulatory news: MDR developments, MDCG guidance, European Commission and competent authority decisions, sector watch.
11 articles
EUDAMED: state of the modules and the 2026 obligation timeline
Since the decision was published in the OJEU on 27 November 2025, four EUDAMED modules have been officially declared functional by the European Commission. As of 28 May 2026, their use becomes mandatory. The Vigilance module is not yet concerned. Here is what this means in practice for manufacturers, authorised representatives and importers.
ISO 13485:2016 confirmed in 2025: no revision under way, the topics to watch
Confirmed without changes on 31 October 2025 at the end of its systematic review, ISO 13485:2016 remains in force and no revision project is open. MDR alignment, cybersecurity, QMS software: topics of discussion, not a revision under way.
MDCG 2019-07 Rev.1 (December 2023): what the revision changes for the role of the PRRC and the authorised representative
December 2023: the MDCG revises its PRRC guidance after four years of MDR implementation. Combining the role with that of the EC REP authorised representative is explicitly ruled out, qualifications are clarified, and obligations are extended to importers who assume the manufacturer's responsibilities. What changes in practical terms for your regulatory organisation.
MDCG 2023-2024 guidelines: what really changes for medical device manufacturers
MDCG guidelines are not legally binding. They become operationally binding the moment a notified body applies them. Five 2023-2024 publications change what is expected in your MDR CE marking files.
MDR and AI Act: regulating medical devices that embed artificial intelligence
Medical devices that embed artificial intelligence now fall under two European regulatory frameworks at once: the MDR (EU) 2017/745 and the AI Act (EU) 2024/1689. Since the MDCG 2025-6 guidance was published in June 2025, the interplay between the two regulations has become clearer: classification under Article 6(1) of the AI Act, integrated conformity assessment through MDR notified bodies, and additional requirements for data governance, transparency and human oversight. With obligations postponed to 2 August 2028 (Regulation (EU) 2026/1744, in force since 27 July 2026), manufacturers gain extra time, not an exemption.
European Commission decisions under the MDR: what SMEs must watch
The European Commission regularly issues delegated acts, implementing acts and common specifications that change the obligations of medical device manufacturers. Harmonised standards, clinical exemptions, MDR revision: these decisions often slip under the radar of SMEs, yet their impact on technical documentation and certification strategies is direct.
Medical device regulatory deadlines 2024-2029: the consolidated timeline for manufacturers
MDR, IVDR, AI Act, EUDAMED: between 2024 and 2029, medical device manufacturers face an unprecedented pile-up of regulatory deadlines. This article consolidates the dates, conditions and real timelines to build into your planning.
MDR notified bodies: state of play mid-2026
52 bodies designated under the MDR in early 2026. That is better than in 2021, but file-review capacity remains a limiting factor. For a medical device manufacturer, the choice of notified body and anticipating timelines shape the entire certification roadmap.
Regulation (EU) 2023/607: extension of the MDR deadlines, who is affected and until when
Regulation (EU) 2023/607 amended Article 120 of the MDR to extend the certification deadlines according to the risk class. Certificate validity is extended by operation of law, but placing on the market is not unconditional: five cumulative conditions, intermediate deadlines that have already passed, and MDR obligations that apply right now. A breakdown article by article.
FDA QMSR: ISO 13485 becomes a legal requirement in the United States
Since 2 February 2026, the FDA has incorporated ISO 13485:2016 into its positive law. Good news in principle for an EU manufacturer already certified. In the detail, several points call for a gap audit before any US move.
ANSM and post-MDR market surveillance: first actions and signals
Self-certified Class I devices, non-compliant labelling, missed vigilance deadlines: the ANSM's first campaigns under the MDR target these three fronts. Its checks are proactive and do not depend on a previously reported incident.
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