Proposed EU MDR/IVDR revision: a regulatory system at a crossroads

The current landscape

More than nine years after the MDR and IVDR entered into force, and several years after their respective dates of application, the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) are the subject of a proposed targeted legislative revision. The Regulations were designed to strengthen patient and user protection, improve transparency and ensure the smooth functioning of the internal market. However, the Commission’s targeted evaluation identified persistent implementation challenges, including lengthy and insufficiently predictable conformity assessment procedures, regulatory costs and administrative burdens, and divergent practices. On 16 December 2025, the European Commission adopted its proposal, COM(2025) 1023 final (2025/0404(COD)), to amend the MDR, IVDR, Regulation (EU) 2022/123 and Regulation (EU) 2024/1689 (AI Act). The proposal is now subject to the ordinary legislative procedure and may therefore change before adoption.

Simplification: what the proposal gets right

The Commission’s proposal contains several potentially significant simplification measures. These include removing the maximum five-year validity period for certificates, while retaining notified body surveillance and introducing periodic reassessment at intervals determined on a risk basis. It would also revise procedures for changes to approved devices and quality management systems, with the detailed allocation between changes requiring prior notified body involvement and other changes governed by the proposed text and applicable conformity assessment arrangements. The proposal would permit more risk-based and representative sampling of technical documentation in specified conformity-assessment procedures, including for certain Class IIa and IIb devices and Class B and C IVDs. It would also allow remote audits where the conditions in the proposed framework are met. The precise scope and operation of these measures remain subject to the final legislative text and any implementing measures.

The proposal would also broaden and clarify the evidence that may support conformity assessment, including, where scientifically justified, non-clinical methods such as modelling and simulation. It introduces an EU-level concept of “well-established technology”, subject to cumulative statutory criteria and, where required, further designation or specification under delegated acts. Devices falling within that framework may benefit from lighter requirements, including specified derogations concerning summaries of safety and clinical performance and notified-body review of periodic safety update reports. The proposal also contains targeted changes for near-patient IVDs, MDR classification rules, software classification, the person responsible for regulatory compliance, periodic safety update reports, and vigilance reporting. These changes are technically detailed and should be assessed against the relevant amending provisions rather than treated as blanket exemptions. In particular, any reclassification of software depends on the amended wording and the software’s intended purpose and risk, and the proposed serious-incident reporting periods differ according to the nature and severity of the incident.

Finally, the push for digitalisation, electronic submission of technical files, digital EU declarations of conformity, digital labelling, and digital provision of information to healthcare professionals and patients, marks a significant step toward a modern regulatory ecosystem.

International cooperation

The proposed international-cooperation provisions would provide a legal basis for closer cooperation with third-country regulators and international organisations, including possible reliance on elements of foreign regulatory assessments where the conditions laid down in Union law are satisfied. The Medical Device Single Audit Program (MDSAP) is relevant in this context because it permits a single quality management system audit to be used by participating regulatory authorities. The proposal does not, however, make the EU a full MDSAP member or provide that an MDSAP certificate, by itself, is sufficient for CE marking. Any recognition or reliance would remain subject to the MDR/IVDR conformity assessment framework and to measures adopted under the revised Regulations.

What this means for your business

The proposal is being considered under the ordinary legislative procedure by the European Parliament and the Council. Its direction is relevant for planning, but businesses should distinguish between measures already applicable under the existing MDR/IVDR framework and amendments that will apply only if and when adopted, and potentially only after transitional periods or implementing measures. The following areas may nevertheless warrant early impact assessment.

If you develop AI-enabled devices or diagnostics: assess both the current AI Act position and the proposed sectoral changes. Regulation (EU) 2026/1744 amended the AI Act, the aviation-safety framework and the Machinery Regulation; it did not itself move the MDR and IVDR references within Annex I of the AI Act. That change remains part of the pending medical-device proposal. Under Article 6(1) of the AI Act, an AI system is classified as high-risk where both statutory conditions are fulfilled: first, the AI system is intended to be used as a safety component of a product, or is itself a product, covered by Union harmonisation legislation listed in Annex I; and second, that product is required to undergo a third-party conformity assessment with a view to its placing on the market or putting into service.

The Commission proposal would move the MDR and IVDR references from Section A to Section B of Annex I to the AI Act and introduce corresponding amendments. The intended effect is to adjust how the AI Act’s high-risk classification and conformity-assessment rules interact with the sectoral MDR/IVDR framework, including by avoiding unnecessary duplication where a medical device or IVD is already subject to sector-specific controls. The change should not be described as making “most AI Act requirements” inapplicable: its precise legal effect depends on the final text, the device and AI-system classification, and the particular AI Act obligation. Manufacturers should continue mapping the requirements of both regimes, including risk management, data governance, technical documentation, human oversight, accuracy, robustness, cybersecurity and post-market monitoring, while engaging early with notified bodies on competence and documentation expectations. AI systems that do not qualify as medical devices or IVDs remain subject to the AI Act where its scope and relevant risk category are met.

If you manufacture connected devices: assess the proposed cybersecurity provisions together with any independently applicable obligations under legislation such as the Cyber Resilience Act or NIS2. The proposal would reinforce cybersecurity within the MDR/IVDR general safety and performance requirements and introduce sector-specific reporting and coordination mechanisms involving competent authorities, computer security incident response teams (CSIRTs) and the European Union Agency for Cybersecurity (ENISA) in the circumstances defined by the proposed rules. The exact trigger, recipient, content and timing of a report should be determined under the final applicable provision; the proposal should not be reduced to a general rule that every vulnerability or severe incident must always be reported to both a CSIRT and ENISA. Manufacturers should align device vigilance, vulnerability handling, patching, quality management and any parallel cyber-reporting workflows.

If you are bringing innovative or niche products to market: the proposal would establish dedicated pathways for devices designated as breakthrough devices or orphan devices, with procedural support that may include prioritisation and rolling review subject to the statutory criteria and available capacity. It also contains transitional measures for certain orphan devices previously certified under the medical-device directives. Eligibility is not automatic and must be assessed against the definitions, designation procedure and evidentiary requirements in the proposed text. The proposal also provides a framework for regulatory sandboxes established under the conditions laid down in the revised Regulations; participation would not disapply essential safety, performance or participant-protection requirements.

If you sponsor clinical studies involving both devices and medicinal products: assess the proposed coordinated pathway against the relevant amending provisions. The proposal would provide for a single application and coordinated assessment for certain clinical studies involving medicinal products, medical devices and/or IVDs, which may reduce procedural complexity and timelines for combination studies. For IVD performance studies, the proposed amendments would also refine when an invasive procedure triggers the full authorisation requirements, with the legal test turning on whether the procedure poses a major clinical risk to subjects. Whether a particular procedure meets that threshold must be assessed case by case under the final text; routine blood draws or finger-pricks should not automatically be equated with higher-risk procedures such as biopsies or lumbar punctures.

If you manufacture single-use devices: review the proposal’s new justification requirements carefully. The proposed amendments would require the manufacturer to substantiate a single-use designation in the technical documentation in accordance with the applicable provision. This is more precise than saying that every device is legally “presumed reusable”: the operative obligation is to justify the single-use designation and address safe reuse within the proposed framework. The separate rules on reprocessing or refurbishment, and on when another operator assumes manufacturer obligations, depend on the activity performed and the definitions and conditions in the MDR as amended. Affected manufacturers should therefore map product design, labelling, reprocessing restrictions and technical-documentation evidence against the final text.

If you supply critical devices: distinguish the proposed framework from the supply-interruption obligations already introduced by Regulation (EU) 2024/1860. The 2025 proposal would further develop Union-level monitoring and coordination for critical devices and would amend Regulation (EU) 2022/123 concerning the role of the European Medicines Agency and expert panels. The scope of any list, IT tool or additional information duty should be checked against the final adopted text and implementing arrangements. Companies should in any event assess supply-chain resilience and their existing MDR/IVDR notification duties.

Looking ahead

Legal status note: This article reflects the Commission’s proposal as of 28 August 2026. The proposal is not yet binding law and may be amended during the legislative process. It should be read together with the MDR, IVDR and subsequent delegated, implementing and guidance measures.

The Commission’s proposal provides a substantial basis for reform.  With targeted refinements on predictability, proportionality and support for innovation, the EU could develop a regulatory framework that facilitates timely patient access to safe technologies, strengthens health systems and supports Europe’s competitiveness in medical-technology development. In the authors’ view, a simpler and more predictable system can support, rather than dilute, safety, patient access and long-term competitiveness, provided that proportionate safeguards and effective oversight are maintained.

For in vitro diagnostics specifically, the amendments to the IVDR remain a central part of the legislative file. The proposal is still under negotiation, and no adoption or application date is legally guaranteed. Any reference to a Commission expectation of application by Q2 2027 should therefore be presented, at most, as an indicative planning assumption rather than a binding timetable. Manufacturers, notified bodies and health institutions should monitor the Parliament and Council positions and assess potential effects on classification, conformity assessment, evidence generation, post-market surveillance, vigilance and supply obligations. Until amendments become applicable, the existing MDR and IVDR, including their current transitional provisions, continue to govern.