Revising the EU device regulations
The European Commission has proposed revising the Medical Device Regulation and the In Vitro Diagnostic Regulation to speed up the demonstration of conformity without lowering the bar for clinical evidence. For a medical writer, the proposal changes which evidence can be used, how equivalence and well-established technology are justified, how documentation is structured and how often it is updated, while several of its terms remain undefined.
Why the regulations are being revised
The MDR and IVDR significantly strengthened regulatory requirements compared with the directives they replaced, which was a positive step for patient safety. But challenges emerged: only 51 notified bodies were designated under the MDR and 19 under the IVDR, and this created a bottleneck of at least 12 to 18 months' wait for CE marking, against 90 days for the whole process at the FDA. Compliance costs increased dramatically, especially for small and medium-sized enterprises, which make up around 90% of European device manufacturers, and there were concerns about barriers to innovation and potential device shortages.
Device strategy shifted as a result. Before the new regulation, Europe was the first place to develop a medical device, because it was less expensive and less regulated; after 2017, companies increasingly went to the FDA first and might return to Europe once they had FDA approval. Device companies also said they would not place their devices on the European market or would withdraw them from it.
The Commission published its revision proposal in December 2025 to address these problems while maintaining patient safety.
The legislative timeline
Through 2026 the European Parliament reviews, debates and negotiates amendments to the proposal, with a final draft expected by the end of 2026 and adoption expected in mid-2027. Gradual implementation is to start after 2027, with no exact dates given. One experienced writer holds that the 2027 date is too short, given how the European Commission works, and hopes for at least a draft by the end of 2026.
Documentation practice can be adapted now rather than after the final text, since in the same writer's judgement the direction is already clear. Current clinical evaluation reports and performance evaluation reports should be reviewed against the evolving expectations to find gaps early, although that writer may wait for the final draft to see the exact impact on clinical evaluation reports.
The revision's objectives
The revision has five main objectives:
- simplifying procedures, to reduce the complexity of conformity assessment
- reducing administrative burden, especially for SMEs
- supporting innovation, so that Europe is not deprived of important breakthrough devices by companies going to the United States first
- improving regulatory predictability, with clearer expectations from notified bodies
- increasing digitalisation, which the notified bodies are also pushing for
One experienced writer holds that the regulation is in a good place for patient safety and that the complexity of its procedures is its collateral damage. The predictability objective responds to a questionnaire by Team-NB, the group of all the notified bodies, which found that the first part of placing a device on the market alone takes 12 to 18 months.
Clinical evidence requirements are not being weakened. The bar remains high, and what is being accelerated is the process of demonstrating conformity. Strong clinical evidence remains essential, and in one experienced writer's view the proposal does not reduce the writer's work but adds to it, while making it more efficient. Clinical evaluation is not removed: the simplification falls on post-market updates, audit frequency, equivalence and the new pathways.
Clinical evidence and equivalence
Changes to equivalence, the expanded use of non-clinical evidence and the concept of well-established technology are among the main changes, and well-established technology is also a main concern for notified bodies.
A broader evidence base
The revision broadens the acceptable evidence base. Where the sources of clinical evidence were narrowly specified, the proposal opens room for other data, such as bench testing, to be accepted as clinical evidence. That gives the writer more flexibility, and it calls for care in how safety and performance are demonstrated from such data.
Non-clinical evidence gains a general role. Before the revision, such data could not be used except through narrow routes such as Article 61(10) of the MDR. The revision encourages alternative methodologies as part of the evidence base, among them bench testing, laboratory testing, computational modelling and simulation studies. So a writer needs to be comfortable describing non-clinical study designs and results and integrating them into a clinical evaluation report or a performance evaluation report.
Equivalence
Under the MDR, equivalence is shown across clinical, technical and biological characteristics, and a class III device, sometimes a class IIb device, may need a contract with the manufacturer of the equivalent device. The revision proposes relaxing certain conditions, which could allow greater reliance on existing evidence, possibly including removing the contract requirement for class III devices.
This does not make equivalence easy. MDCG guidance still governs how equivalence is demonstrated, similarity across clinical, technical and biological characteristics still has to be shown, and the justification must always be scientifically rigorous.
Well-established technology
Well-established technology is not a new term; it is currently defined mainly in MDCG guidance, and the proposal provides for defining it in MDCG guidance under the new framework. It applies to devices based on technology with a long track record of safe use, and it has three criteria:
- long clinical use: a documented history of use in clinical practice over many years
- an extensive safety history: a well-characterised safety profile with predictable risks
- strong literature support: a robust body of published scientific evidence
A device that meets all three criteria may qualify for proportionate clinical evidence requirements, with a reduced level of compliance and less need for new investigation, but the justification must be solid.
Breakthrough and orphan devices
The revision creates two new pathways for innovation. A breakthrough device, as at the FDA, presents a significant advance over existing alternatives and incorporates new technology not already on the market, and it would receive priority assessment, dedicated notified-body engagement and potentially accelerated timelines. An orphan device serves a rare condition with a small patient population, and it would benefit from adapted clinical evidence requirements, since sample sizes are small and large-scale investigation may not be feasible.
Both pathways require strong scientific justification, which gives medical writers work to do. The writer has to build a compelling narrative for why a device qualifies and why the adapted evidence package is sufficient.
Digital regulatory documentation
The revision promotes a significant move to digital regulatory processes:
- digital declarations of conformity, replacing paper documents
- electronic instructions for use, reducing the need for printed instructions, which has already been adopted
- digital technical documentation that is structured, searchable and version-controlled
- electronic regulatory submission, to speed up interaction with the notified body
For a medical writer this means adapting to structured document formats. One experienced writer reads the direction as making submitted documentation readable by a large language model, so that AI can read it and flag what is and is not coherent.
A writer should learn to work with the new tools, such as electronic quality management systems and platforms for producing a state of the art, or at least understand how such documentation must be structured, so as to be ready when the new framework is in place. The European Commission and the notified bodies are pushing for digitalisation, and a writer who does not understand it risks being replaced by writers who use AI and digital tools.
Certification and post-market cycles
Several proposed changes to certification and surveillance bear directly on notified bodies:
- removal of the fixed certificate validity period, with certificates reviewed on a risk schedule rather than renewed every five years
- greater use of remote audits, to reduce logistical burden
- less frequent surveillance audits, based on the compliance track record
On the post-market side, where many manufacturers struggle, the revision adjusts some obligations. Update frequency may be reduced for lower-risk devices, on the reasoning that a device that is not high risk needs less review, as at the FDA. Incident reporting timelines are adjusted to be more practical, which also reduces post-market updating.
The clinical evaluation report still has to be maintained and updated, even though the period for updates may be reduced. The documentation obligation does not disappear, and the review cycle becomes more risk-appropriate. Post-market clinical follow-up obligations also remain strong, and an active, ongoing PMCF plan is still required.
In vitro diagnostics
The transition to the IVDR has, by one practitioner's observation, faced even greater challenges than the MDR's, partly because IVD manufacturers had less experience of notified-body involvement. The proposal would:
- remove the performance evaluation consultation procedure that the IVDR introduced, simplifying the pathway for high-risk IVDs
- simplify authorisation requirements for certain performance studies
- allow greater flexibility in referencing equivalent IVDs
A writer of performance evaluation reports should watch closely how these changes affect evidence.
The notified bodies' response
In March 2026 Team-NB published a position paper giving the collective view of the European notified bodies on the proposal. They welcomed better data-driven digital technical documentation, earlier regulatory dialogue with manufacturers, and faster post-market access, which could reduce duplicative work given the reduced updates.
Their concerns carry weight because notified bodies are the gatekeepers of CE marking: the manufacturer sends the technical file and documentation to the notified body, whose review decides whether the device can go on the market. Their first concern is reduced regulatory scrutiny. Fewer audits means fewer unannounced audits, which weakens oversight and compliance information, leaves the notified body unable to be sure that technical documentation is up to date, and may mean fewer safety signals are caught during the device's life cycle.
They also dispute the proposal's economics. The Commission's proposal claims a saving of 2.1 billion, and Team-NB holds that this is not realistic, because the total revenue of all notified bodies is 475 million. The proposed changes would reduce many constraints on notified bodies, and with them, by one practitioner's reading, some of their revenue.
One experienced writer expects that, if the proposal is implemented correctly and the red flags raised by notified bodies and consultants are addressed, the result will be an MDR and IVDR that are practical, efficient and safe for patients.
Definitions still to be settled
Several definitions still need clarification, among them well-established technology, the Basic UDI-DI and the equivalence criteria. The uncertainty that remains recalls the early period of the MDR, when writers and device companies lacked a clear view of the future.
The medical writer is the bridge between clinical data, regulatory requirements and clinical evidence, and has to keep adapting to each change and translating the requirements into structured documentation. The regulation keeps changing, so documentation should always be kept adaptable.