Everyone Is Only Reading The MDR Half Of Europe's Reform

By Marcelo Trevino, independent expert

The European Commission published COM(2025) 1023 on December 16, 2025. Since then, the commentary has been remarkably consistent: classification rules are relaxed for certain devices, fixed five-year recertification cycles are removed, breakthrough pathways are introduced, and notified body timelines are made predictable. There is roughly 30 percent less administrative burden, with estimated savings above 3 billion euros a year.

Almost all of that is written from the MDR side.

MedTech Europe said so directly in its May position paper, cautioning that the IVDR amendments have received insufficient attention given their importance to healthcare systems. That was four months ago. The gap has not closed.

It matters now because the legislative clock is running. The Rapporteur in the European Parliament's Committee on Public Health published his draft report on July 1, carrying more than 130 proposed amendments. The deadline for political groups to submit their own amendments passed on July 20. Technical meetings run through the fall, with a plenary vote expected around the new year.

The text that diagnostics manufacturers will live with for the next decade is being shaped over the next few months, largely by people responding to an MDR framing of the problem.

Why IVDs Were Always Going To Be The Second Half

The imbalance is not an accident. It is structural.

The MDR became applicable in May 2021, the IVDR a year later. Both were extended when it became clear that notified body capacity could not absorb the volume of legacy devices needing certification. But the two extensions did not run on the same clock. IVDR transitional periods now end on December 31, 2027, 2028, or 2029 depending on risk class. A large share of the IVD installed base is still operating under IVDD certificates or declarations of conformity, which means much of the industry has not yet completed a full IVDR conformity cycle.

That has a consequence for the reform. The evidence base the Commission drew on to identify pain points came disproportionately from manufacturers that had been through MDR certification and could describe what went wrong. IVD manufacturers, many still in transition, had a thinner record to contribute. The proposal reflects the data it received.

The same asymmetry shows up in the surrounding guidance. MDCG published its Q&A on IVDR performance studies, MDCG 2025-5, in June 2025. The equivalent MDR guidance for clinical investigations, MDCG 2021-6, had been available for four years by then. Team NB released version 2 of its position on companion diagnostic changes under IVDR Annex IX, Section 5.2, in October 2025. ISO 20916:2024 now carries an Annex ZA mapping its clauses to IVDR requirements, but it is not yet listed as a harmonized standard in the Official Journal, so notified bodies reference it informally during review.

Diagnostics has been catching up on guidance while the primary legislation is being rewritten. That is a difficult position from which to influence the rewrite.

What The Proposal Actually Does For IVDs

Three changes are specific to in vitro diagnostics, and each carries more weight than its word count suggests.

• Performance studies lose two external gates. Studies involving only routine blood draws would no longer require prior authorization. The notification requirement for companion diagnostic performance studies using leftover specimens would be removed entirely. Under the current text, Article 58 studies for investigational companion diagnostics with prospectively collected specimens require authorization, Article 70 post-market studies generally require notification, and leftover specimen studies sit in a gray zone that MDCG 2025-5 tried to clarify with a decision flowchart. The proposal resolves part of that gray zone by removing the step altogether.
• Equivalence becomes scientifically substantiated rather than contractually gated. The proposal removes the requirement to hold a contract with the manufacturer of an equivalent device in order to access its technical documentation. That requirement was the practical reason equivalence became nearly unusable under the current framework. Competitors do not sign such contracts. What replaces it is a burden of scientific justification, which is a higher bar for the evidence and a lower bar for the paperwork.
• AI requirements move inside the framework. Under the proposal, AI-enabled devices classified as high-risk AI systems would not need to comply with the AI Act in addition to MDR or IVDR. AI-specific requirements would instead be integrated into the device framework through delegated or implementing acts. For diagnostics, this is not a niche question. Interpretive software, variant classification, image-based assays, and decision-support layers on top of assay output all sit near the boundary. MedTech Europe has flagged that the drafting does not yet deliver the legal clarity this requires, and until the delegated acts exist, the boundary is a matter of interpretation.

Alongside these, the cross-cutting changes apply with full force to IVDs: open-ended certificates in place of fixed renewal cycles, streamlined change control, structured notified body dialogue, and digitalized submissions. Implementing Regulation (EU) 2026/977 has already set uniform requirements for conformity assessment and notified bodies under Annex VII, and EUDAMED actor and device registration became mandatory on May 28, 2026. The infrastructure the reform assumes is arriving ahead of the reform itself.

The Part That Gets Missed

Read those three changes as a regulatory affairs win and the conclusion is that workload goes down.

Read them as a quality leader and something different comes into view. Every one of them removes an external checkpoint. None of them removes the underlying obligation.

When a competent authority reviews a performance study protocol, it is also reviewing the evidence plan behind it. Take away the authorization step and the protocol still has to be sound. What changes is who catches the weakness. Without external review, a flawed protocol surfaces later, during notified body assessment or through a post-market signal, at a point where fixing it costs far more than getting it right the first time.

Equivalence without a contract works the same way. The contract was a blunt instrument, but it forced a conversation about whether the two devices were actually comparable. Scientific substantiation demands a better argument and provides no one to argue with until the notified body reads it.

Open-ended certificates follow the same pattern. A fixed recertification cycle sets a deadline. Evidence gets assembled, gaps get closed, and someone signs, because the date requires it. Without that cycle, the obligation does not go away. It becomes continuous. A post-market surveillance system designed to prepare for a renewal every five years is a different system from one that can demonstrate conformity at any point in time. Most PMPF plans were written for the first kind. They will need to work as the second.

Simplification of process is not reduction of evidence. It is a transfer of control from the external body to the quality management system. Organizations with mature surveillance and change control will absorb it and move faster. Organizations that have leaned on external gates will find the gates were doing real work.

What The Parliament Draft Report Signals

The draft report is broadly supportive of the Commission's direction toward proportionality, which means the shape of the reform is unlikely to change fundamentally. What the 130-plus amendments do is adjust the edges, and some of those edges are IVD-specific.

One example is the exemption for devices manufactured and used within a single health institution. Under the current IVDR, such devices are exempt from most obligations except the general safety and performance requirements, subject to conditions. How that exemption is drawn affects every commercial IVD manufacturer competing against laboratory-developed testing, and it is one of the places where diagnostics-specific input during the technical meetings will matter.

The other place is the AI integration. If the delegated act mechanism survives negotiation, the substantive requirements for AI-enabled diagnostics will be written after the primary legislation passes, by the Commission, on a timeline the industry does not control. The time to shape the scope and the constraints of that mechanism is during the current negotiation, not after.

What Happens If The Diagnostics Side Stays Quiet

It is worth being concrete about the cost of silence, because the failure mode here is not dramatic. It is a text that works reasonably well for devices and awkwardly for tests.

Take the performance study exemption. As drafted, it hinges on routine blood draws. Saliva, urine, cheek swabs, and stool are just as minimally invasive and just as common in modern diagnostics, but if the wording stays narrow, a study built on a cheek swab could end up with more procedural friction than one built on a blood draw. That is not simplification. It is a new gray zone with a different shape.

Or take the AI delegated acts. If they are drafted with imaging software and stand-alone decision-support in mind, the change control expectations may be poorly matched to a locked interpretive algorithm sitting behind an assay. A minor pipeline update could be treated as a major change, or the reverse, depending on definitions nobody in diagnostics helped write.

And take open-ended certificates. Without IVD-specific expectations for post-market performance follow-up, notified bodies will do the reasonable thing and adapt their MDR templates. Manufacturers will then spend the next several years explaining why clinical performance evidence for a test looks different from clinical evidence for an implant.

None of these outcomes requires bad faith. They only require that the people writing the details hear mostly from one half of the industry.

5 Moves Worth Making Before The Plenary Vote

1. Map the performance study portfolio against the exempted categories. Identify which planned studies would fall outside prior authorization or notification, and decide now what internal review replaces the step. If the answer is nothing, that is a decision, and it should be made deliberately rather than by default.
2. Pressure-test post-market performance follow-up against a no-renewal-date scenario. The question is whether PMPF output would support a conformity conclusion at an arbitrary point in time, not only at certificate renewal. If the plan reads like a countdown to a date, it was written for the old framework.
3. Rebuild the equivalence file as a scientific argument. For any product where equivalence was abandoned because a contract was unobtainable, revisit the case on its merits. The route may reopen, and the evidence standard will be higher than it was.
4. Inventory algorithm-containing assays now. If AI requirements arrive through delegated acts rather than a parallel statute, the implementation detail lands later and faster than the primary legislation. Knowing which products are in scope is the inexpensive part. Do it while it is inexpensive.
5. Get an IVD-specific position in front of your trade association before the fall technical meetings. MedTech Europe's IVD Working Group is the obvious channel at the EU level. Nationally, VDGH in Germany, BIVDA in the U.K., and SNITEM in France carry weight with their member states' delegations in Council. U.S.-based manufacturers selling into Europe can route through AdvaMedDx, which coordinates with the European associations. The amendments under negotiation were drafted largely in response to MDR concerns. Diagnostics-specific input is underrepresented for a simple reason: fewer people are submitting it.

Conclusion

None of this is law yet. Current obligations stand until the revision is formally adopted, and the text will change between now and then. Anyone treating the December proposal as a settled outcome is planning against a moving target.

That is exactly the point. The MDR provisions will be scrutinized line by line because a large and well-organized constituency is reading them. The IVDR provisions will pass with less attention, fewer amendments, and thinner guidance behind them, and they will land with identical legal force.

The reform will be remembered as a simplification. For diagnostics, the more accurate word is relocation. Authorization steps, contractual gates, and fixed renewal cycles are being removed from the outside of the system and reappearing as evidence expectations on the inside. Whether that feels like relief or exposure depends entirely on how the quality system was built.

If you work in diagnostics, the reform is not happening to the other half of the industry. It is happening to yours, and the deciding conversations are taking place with half the room empty.

About The Author:

Marcelo Trevino has more than 25 years of experience in global regulatory affairs, quality, and compliance, serving in senior leadership roles while managing a variety of medical devices: surgical heart valves, patient monitoring devices, insulin pump therapies, surgical instruments, orthopedics, medical imaging/surgical navigation, in vitro diagnostic devices, and medical device sterilization and disinfection products. He has an extensive knowledge of medical device management systems and medical device regulations worldwide (ISO 13485:2016, ISO 14971:2019, EU MDR/IVDR, MDSAP). He holds a BS in industrial and systems engineering and an MBA in supply chain management from the W.P. Carey School of Business at Arizona State University. Trevino is also a certified Medical Device Master Auditor and Master Auditor in Quality Management Systems by Exemplar Global. He has experience working on Lean Six Sigma Projects and many quality/regulatory affairs initiatives in the U.S. and around the world, including third-party auditing through Notified Bodies, supplier audits, risk management, process validation, and remediation. He can be reached at marcelotrevino@outlook.com or on LinkedIn.