{"id":10558,"date":"2026-03-27T16:26:08","date_gmt":"2026-03-27T15:26:08","guid":{"rendered":"https:\/\/ibj.be\/news-fr\/the-mdr-ivdr-reform-proposal-simpler-rules-higher-expectations\/"},"modified":"2026-03-27T16:27:13","modified_gmt":"2026-03-27T15:27:13","slug":"the-mdr-ivdr-reform-proposal-simpler-rules-higher-expectations","status":"publish","type":"post","link":"https:\/\/ibj.be\/fr\/partnerblog-fr\/the-mdr-ivdr-reform-proposal-simpler-rules-higher-expectations\/","title":{"rendered":"The MDR\/IVDR reform proposal: simpler rules, higher expectations"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">On 16 December 2025, the European Commission published its <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:52025PC1023\">proposal<\/a> to amend the rules governing medical devices and in vitro diagnostic medical devices in the European Union \u2014 the <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/eng\">MDR<\/a> and <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/746\/oj\/eng\">IVDR<\/a> \u2014 under the formal reference COM(2025)1023. The label attached to the exercise is \u00ab\u00a0simplification.\u00a0\u00bb The substance is more ambitious than that.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">To understand why, it helps to recall the context from which the proposal emerges. The MDR and IVDR have undoubtedly raised the bar on patient safety and clinical evidence. Their implementation has, however, exposed fault lines that could no longer be ignored: certification bottlenecks driven by notified body capacity constraints, compliance costs that bear little relation to actual clinical risk, and mounting concerns about the continued availability of certain long-established devices. These are not marginal issues. They go to the structural viability of the framework itself, and the European Commission acknowledges as much in the proposal&rsquo;s recitals.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">What emerges from the EC proposal is therefore not a technical cleanup, but a recalibration, one that touches lifecycle governance, evidence methodology, software classification and the interaction with the AI Act. The significance of the proposal lies less in any individual amendment than in how, taken together, those changes reshape the underlying logic of the framework. What that means in practice is less obvious than the word \u00ab\u00a0simplification\u00a0\u00bb suggests.<\/p>\n\n\n\n<div class=\"wp-block-stackable-heading stk-block-heading stk-block-heading--v2 stk-block stk-7887d7d\" id=\"three-structural-shifts\" data-block-id=\"7887d7d\"><style>.stk-7887d7d {margin-bottom:15px !important;}<\/style><h4 class=\"stk-block-heading__text\">Three structural shifts<\/h4><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">Three developments are worth highlighting at the outset, as they set the tone for the reform as a whole.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The first is the move away from fixed recertification cycles. Under Article 56(2) MDR, notified body certificates carry a maximum validity of five years. The proposal removes that fixed cap, replacing it with a risk-based approach to ongoing surveillance carried out by the notified body while the certificate remains valid. Regulatory oversight becomes more continuous, with its intensity more closely aligned to the actual risk profile of the device.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The second is greater differentiation across product categories. The most discussed amendment concerns Rule 11 of Annex VIII, which governs the classification of medical device software. The proposal introduces a more refined risk-based logic: software addressing clinical situations of lower severity may fall into a lower risk class, potentially reducing or removing the need for notified body involvement. In practice, however, the scope of that shift is more limited than it might initially appear. Rule 11 as amended continues to classify software as Class IIa where it provides information used for decisions in non-serious clinical situations, a threshold that on most readings still captures a broad range of software functionalities. Genuinely Class I medical device software is therefore likely to remain the exception rather than the rule.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Beyond software, the proposal introduces dedicated pathways for breakthrough devices and orphan devices, both of which give manufacturers access to an expedited review process and to scientific advice from an expert panel. The proposal also introduces regulatory sandboxes, in which certain MDR and IVDR requirements may be suspended to allow real-world testing of devices addressing unmet medical needs.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The third shift concerns how safety and performance can be demonstrated. The proposal allows a wider range of data to qualify as clinical evidence, makes the conditions for relying on data from equivalent devices more flexible, and expands the circumstances in which safety and performance may be demonstrated on the basis of non-clinical data alone. That flexibility is not unconditional: it does not replace the need for rigorous justification of the chosen approach, nor does it alter the fundamental requirement that the level of clinical evidence must remain appropriate in view of the characteristics and intended purpose of the device.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Taken together, these shifts point towards a compliance model that is more dynamic and risk-sensitive, but also one that places greater demands on the quality of internal reasoning and documentation. How a product is classified, what evidence strategy is chosen, whether a device qualifies for one of the new special categories: each of these becomes a substantive regulatory decision in its own right, not merely a procedural step.<\/p>\n\n\n\n<div class=\"wp-block-stackable-heading stk-block-heading stk-block-heading--v2 stk-block stk-c399712\" id=\"from-regulatory-event-to-continuous-governance\" data-block-id=\"c399712\"><style>.stk-c399712 {margin-bottom:15px !important;}<\/style><h4 class=\"stk-block-heading__text\">From regulatory event to continuous governance<\/h4><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">One area where these shifts become particularly concrete is lifecycle management. Under the current MDR framework, regulatory oversight of product changes is largely triggered on a case-by-case basis. For technologies that evolve iteratively, particularly software and connected devices, this creates inherent tension between product development and regulatory requirements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The EC proposal addresses this tension not by removing regulatory control, but by restructuring it. The proposal introduces a legal basis in Annex VII MDR for structured pre- and post-submission dialogues between manufacturers and notified bodies, and provides that both parties should, where appropriate, agree on a change control plan setting out in advance which changes require prior approval and which do not. One important caveat applies: for this new regime to take practical effect, notified bodies will first need to update their own procedures and certification agreements accordingly, which may introduce a time lag between the entry into force of the amended framework and its application in practice.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The framework is moving from episodic intervention towards continuous governance, in which the quality of how product evolution is anticipated, documented and managed matters as much as the substance of any individual change.<\/p>\n\n\n\n<div class=\"wp-block-stackable-heading stk-block-heading stk-block-heading--v2 stk-block stk-c8aad82\" id=\"software-and-ai-enabled-devices-an-unsettled-picture\" data-block-id=\"c8aad82\"><style>.stk-c8aad82 {margin-bottom:15px !important;}<\/style><h4 class=\"stk-block-heading__text\">Software and AI-enabled devices: an unsettled picture<\/h4><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">The implications for AI-enabled devices are where the proposal is most consequential and most uncertain.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Under the current AI Act, medical devices incorporating AI fall under Section A of Annex I, triggering the full set of high-risk AI obligations covering data governance, transparency, human oversight, robustness and post-market monitoring, which apply in parallel to the MDR and IVDR requirements. The proposal moves the MDR and IVDR to Section B of Annex I. The legal consequence, under Article 2(2) of the AI Act, is precise: the substantive high-risk obligations under Chapter III of the AI Act no longer apply automatically to AI-enabled medical devices. The Commission&rsquo;s rationale is that the MDR and IVDR frameworks provide sufficient guarantees without that additional layer.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Whether that position will survive the legislative process is a different question. The proposal sits in direct tension with the parallel Digital Omnibus Package of 19 November 2025, which approaches the same challenge from a fundamentally different angle. Rat<a><\/a>her than removing medical AI from the AI Act&rsquo;s high-risk framework, the Digital Omnibus keeps the substantive obligations in place but makes them more workable: it postpones their application until relevant harmonised standards are available, and clarifies that compliance can be demonstrated through an integrated MDR\/IVDR conformity assessment. The two proposals reflect competing visions originating from different parts of the Commission. Their tension may be resolved through amendments during the legislative process, or it may persist into the final adopted texts. Until the position is settled, manufacturers of AI-enabled devices should be cautious about restructuring their compliance architecture on the basis of either proposal alone.<\/p>\n\n\n\n<div class=\"wp-block-stackable-heading stk-block-heading stk-block-heading--v2 stk-block stk-8a5b561\" id=\"notified-bodies-fewer-touchpoints-higher-stakes\" data-block-id=\"8a5b561\"><style>.stk-8a5b561 {margin-bottom:15px !important;}<\/style><h4 class=\"stk-block-heading__text\">Notified bodies: fewer touchpoints, higher stakes<\/h4><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">The proposal does not alter the central position of notified bodies within the conformity assessment framework. It does reconfigure how their capacity is deployed. Involvement is reduced for lower-risk devices, surveillance audits move to a two-year cycle where justified, and remote audits become available. These changes reduce the frequency of touchpoints for many manufacturers.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">What they do not reduce is the significance of those touchpoints when they occur. As assessments increasingly focus on change control frameworks, software functionalities, evolving evidence sets and the justification of classification decisions, the choice of notified body increasingly depends not only on designation and availability, but on demonstrated capability to assess these elements in a consistent and integrated manner.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">It is also worth noting that on 12 December 2025, the Commission published a separate draft implementing regulation (Ares(2025)11081575) introducing uniform quality management and procedural requirements for notified bodies, addressing long-standing concerns about divergent practices and unpredictable assessment timelines. It should be read alongside EC proposal COM(2025)1023 as part of the same broader effort.<\/p>\n\n\n\n<div class=\"wp-block-stackable-heading stk-block-heading stk-block-heading--v2 stk-block stk-c040a77\" id=\"the-shift-is-already-underway\" data-block-id=\"c040a77\"><style>.stk-c040a77 {margin-bottom:15px !important;}<\/style><h4 class=\"stk-block-heading__text\">The shift is already underway<\/h4><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">The EC proposal is presented as a simplification exercise. In substance, it is something more consequential: a recalibration of the regulatory model governing medical devices in Europe, away from static, procedure-driven compliance and towards a framework that is more continuous, more risk-differentiated and more demanding of internal governance quality. The proposal remains subject to the ordinary legislative procedure, and the existing MDR and IVDR frameworks continue to apply in the interim. It should not be relied upon to defer ongoing compliance efforts.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">That said, the direction of travel is sufficiently clear to draw conclusions now. The reform does not simply adjust existing procedures, it redefines what sound regulatory governance looks like. A compliance model built around standardised documentation and periodic certification events will increasingly struggle to meet the expectations of a framework that rewards continuous oversight, defensible reasoning and integrated governance across legal, regulatory, data and product functions.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The companies best positioned as this framework takes shape will not be those that wait for the legislative text to be finalised. They will be those that have already started asking the harder questions: how product evolution is governed, how evidence choices are made and documented, and how the organisation engages with its notified body not as a gatekeeper, but as a long-term partner in an ongoing regulatory dialogue.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Author<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Eline\u00a0Alders<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 16 December 2025, the European Commission published its proposal to amend the rules governing medical devices and in vitro diagnostic medical devices in the European Union \u2014 the MDR and IVDR \u2014 under the formal reference COM(2025)1023. The label attached to the exercise is \u00ab\u00a0simplification.\u00a0\u00bb The substance is more ambitious than that.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[62],"tags":[],"class_list":["post-10558","post","type-post","status-publish","format-standard","hentry","category-partnerblog-fr"],"blocksy_meta":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>The MDR\/IVDR reform proposal: simpler rules, higher expectations - IBJ - IJE<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ibj.be\/fr\/partnerblog-fr\/the-mdr-ivdr-reform-proposal-simpler-rules-higher-expectations\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The MDR\/IVDR reform proposal: simpler rules, higher expectations - IBJ - IJE\" \/>\n<meta property=\"og:description\" content=\"On 16 December 2025, the European Commission published its proposal to amend the rules governing medical devices and in vitro diagnostic medical devices in the European Union \u2014 the MDR and IVDR \u2014 under the formal reference COM(2025)1023. 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