MDR/IVDR revision: "simplification" will not save manufacturers whose documentation is scattered

On December 16, 2025, the European Commission presented its proposal for a targeted revision of the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostics Regulation (IVDR 2017/746). On June 16, 2026, a progress report was presented to the EPSCO Council, confirming progress on scope, governance, notified bodies, classification, and post-market surveillance. The public consultation gathered hundreds of contributions, and the French Parliament itself took up the subject, with an information report from the French Senate filed on July 1, 2026.

The watchword is everywhere the same: simplification. After years of bottlenecks at notified bodies, exploding certification timelines, and devices pulled from the European market for lack of viable recertification, the Commission wants to make the framework "simpler and more predictable."

For manufacturers, it is tempting to see in this the promise of a general reduction in burden and to adjust priorities accordingly: freeze investments in quality and documentation systems, wait for the final text, and hope the load goes down. This article makes the opposite case: the revision will redistribute the regulatory burden, not reduce it, and manufacturers whose technical documentation is scattered will be the losers of that redistribution.

What the revision really simplifies

Let us be precise about what the proposal contains, because the word "simplification" covers very different realities.

The revision aims first at procedural simplifications: reducing redundancies in certification processes, harmonizing notified body practices, easing certain obligations for legacy devices and for orphan or pediatric devices, and smoothing governance between member states. It then aims at calendar adjustments, in continuity with Regulation 2023/607, which had already extended the transitional periods to 2027 or 2028 depending on device classes. Finally, it relies on the Eudamed infrastructure, whose four essential modules (actors, UDI/devices, certificates, notified bodies) have been operational since January 2026, with the vigilance and market surveillance modules in final deployment.

What the revision does not touch, on the other hand, is the core of the burden of proof. No one, neither at the Commission, nor at the Parliament, nor at the Council, is proposing to reduce the requirements relating to technical documentation, clinical evaluation, risk management under ISO 14971, UDI traceability, or post-market surveillance. The political consensus rests on one principle: maintain the level of safety, reduce administrative friction.

Operational translation: the manufacturer will have to demonstrate the same thing as before, but the circuits of demonstration will be smoother. This is excellent news for those whose problem was the queue. It is bad news for those whose problem was the content of the dossier.

The queue was masking a deeper problem

Since 2021, the shortage of notified bodies has served as a universal explanation for certification difficulties. It was real: in March 2023, more than 22,000 certificates were still waiting to be processed. But it masked a second, less comfortable reality: a growing proportion of dossiers submitted to notified bodies was being judged incomplete.

An incomplete dossier, in the MDR world, is almost never a dossier missing a chapter. It is a dossier whose elements do not answer one another: a risk analysis that references a version of the device earlier than the one described in the technical documentation, general safety and performance requirements (GSPR) whose coverage matrix points to obsolete test reports, a clinical evaluation whose scope no longer exactly matches the marketed variants, instructions for use out of sync with the risk management file.

These inconsistencies have a single structural cause: the technical documentation of a medical device is a system of several dozen interdependent documents, maintained with tools that ignore those interdependencies. Word does not know that a paragraph of the specification is linked to a line of the GSPR matrix. Excel does not know that line 247 of the matrix points to a test report that was revised last month. Each product change triggers a cascade of documentary updates whose completeness rests entirely on human vigilance.

When notified bodies regain capacity, thanks precisely to the simplification measures, this underlying weakness will become the main limiting factor. Manufacturers will spend less time waiting, and the shortcomings of their dossiers will become visible faster.

The hidden cost: product evolution

There is a second reason why documentary structuring is about to become critical: devices are evolving faster and faster.

The medical device of 2026 is increasingly a system: hardware, embedded software, companion app, connectivity, sometimes machine learning algorithms. Each component has its own pace of evolution. Software updates several times a year, electronic components go obsolete, suppliers change, and export market demands impose variants.

Yet the MDR, revised or not, rests on an unshakeable principle: the technical documentation describes the device as it is placed on the market, continuously. Every significant change must be assessed (is it a significant change?), documented, and where applicable notified to the notified body. Post-market surveillance must loop back to risk management, which must loop back to design.

For a manufacturer who manages this loop with documents, each iteration produces synchronization work: identify all impacted documents, revise them, circulate the revisions, and verify the consistency of the whole. The QARA teams we meet all describe the same situation: they spend most of their time not on assessing risks or analyzing clinical data, but on maintaining the consistency of a documentary corpus that is constantly falling out of sync.

At the scale of a medtech startup aiming for CE marking of a class IIb or III device, this friction is counted in months of time-to-market. At the scale of a mid-sized company with a portfolio of devices, it is counted in full-time equivalents.

Structure rather than stack: the traceability thread

The solution is not to write more documents, nor to hire more writers. It consists of changing the nature of the object being maintained: replacing the corpus of documents with a graph-based repository, whose documents become generated views.

Concretely, this means representing as interconnected objects: regulatory (GSPR) and normative requirements; product requirements and specifications; risks, their control measures, and their verifications; hardware and software design elements with their versions; evidence (test reports, clinical data, validations); and marketed variants and configurations.

In this representation, the question "what is the coverage of GSPR 14.2 for the export variant of the device in version 3.1?" becomes a query, with an instant and always up-to-date answer. The impact analysis of a software modification becomes a traversal of the graph: requirements affected, risks to reassess, tests to rerun, documentation sections to regenerate. And the technical dossier submitted to the notified body becomes a dated and versioned extraction from the repository, whose internal consistency is guaranteed by construction.

This is exactly the model that Koddex implements: a graph-based engineering repository that connects requirements, design, risks, and evidence, and that maintains the traceability thread end to end, from the regulatory requirement to the proof of compliance. For teams already using classic requirements management tools, the approach is complementary: where those tools manage lists, Koddex manages relationships, which are precisely what auditors examine.

The 2026-2028 window: three scenarios

Between now and the definitive adoption of the revision and the 2027-2028 deadlines of the transitional periods, three scenarios are open to manufacturers.

The first scenario is wait-and-see: freeze investments while waiting for the final text. It is the riskiest, because the recertification deadlines, for the most part, do not move, and notified body capacity will remain constrained in the short term. Counting on the timelines, as several industry experts keep repeating, is a strategic mistake.

The second scenario is quantitative reinforcement: recruit in QARA, outsource the writing, absorb the load through headcount. It is the default scenario for many mid-sized companies. It works, but its cost grows linearly with the portfolio, and it does not reduce the risk of inconsistency, which is a structural risk, not a headcount risk.

The third scenario is structuring: use the window to migrate the technical documentation to a traceable repository, product by product, starting with the devices whose recertification comes first. It is the only scenario that turns every euro invested into a durable reduction of the cost of compliance and of time-to-market.

Conclusion: simplification will favor the best-structured

The revision of the MDR and the IVDR is good news for the sector, and it should be welcomed. But it must be read for what it is: a smoothing of the circuits, not a reduction of the requirements of proof. In a smoother system, the competitive advantage shifts toward those who produce the proof quickly and well.

The question to ask is therefore not "how much will the revision save us?" but "when the circuits are smooth, will we be able to feed them consistent dossiers at the pace of our product evolutions?" For manufacturers whose documentation lives in an archipelago of files, the honest answer is no. And it is that project, far more than the text from Brussels, that will determine who gains market share in European medtech by 2030.

Sources

- Proposal for a Regulation amending MDR (2017/745) and IVDR (2017/746), COM(2025) 1023 final (European Commission, 16 December 2025)
- Employment, Social Policy, Health and Consumer Affairs Council (Health), 16 June 2026 (Council of the European Union, 16 June 2026)
- Revision de la reglementation europeenne applicable aux dispositifs medicaux et aux dispositifs medicaux de diagnostic in vitro, rapport d'information n. 840 (2025-2026) (Senat francais, 1 July 2026)
- Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions (EUR-Lex, 15 March 2023)
- EUDAMED: four first modules mandatory to use as from 28 May 2026 (European Commission, 27 November 2025)
- Regulation (EU) 2017/745 on medical devices (MDR) (EUR-Lex, 5 April 2017)
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) (EUR-Lex, 5 April 2017)
- Notified bodies have yet to issue MDR certificates for 85% of legacy devices: survey (MedTech Dive, April 2023)

Koddex helps medical device manufacturers structure requirements, risks, design, and evidence in an end-to-end traceable repository. Our early adopter offer includes the initial modeling of your data. Contact us for a demonstration.