EP could ask tighter controls on clinical evidence, equivalence, niche devices and post-market surveillance.

Brussels, 9 August 2026 — The European Union’s attempt to repair its medical devices framework is entering a more political phase. Last December 2025, the Commission proposed a targeted revision of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation to simplify certification, reduce administrative burden and improve predictability.

Now the European Parliament’s rapporteur, Oliver Schenk, has put forward a draft report that broadly accepts the direction of simplification — but tries to add safeguards where deregulation could become too risky. The Schenk draft does more than add safety brakes. In some areas, it also appears to tighten the calendar.

Compared with the Commission’s more flexible approach, the rapporteur would require an initial PSUR for certain devices within a defined period and would cap initial certificates of breakthrough, orphan and niche devices certified on limited clinical data. The message is therefore more nuanced than simple deregulation: fewer unnecessary renewals, but clearer deadlines where evidence and post-market follow-up matter most.

The file matters far beyond legal departments. Europe’s medical technology industry includes more than 38,000 companies, around 90% of them SMEs, employs more than 930,000 people and was estimated by the Commission at around €170 billion in 2024. The Commission says the reform is intended to make the system simpler, more predictable and less costly while preserving public health protection and patient safety.

The Schenk draft is not yet Parliament’s position. The procedure is still awaiting a committee decision, and the text remains subject to amendments, committee vote and later negotiations with the Council. But for manufacturers, notified bodies, hospitals, investors and regulatory consultants, the draft already gives an important signal: Parliament may support simplification, but not a blank cheque.


The Commission’s baseline: simplify, digitalise, reduce repetition

The Commission proposal, COM(2025)1023, is designed to amend the MDR, the IVDR, the EMA crisis regulation and the AI Act’s Annex I list of Union harmonisation legislation. Its stated objective is to simplify and reduce the burden of the rules on medical devices and IVDs.

The proposal targets several known pressure points: certification bottlenecks, notified-body capacity, disproportionate requirements, repeated certificate renewals, burdensome PSUR obligations, classification rules, digitalisation of technical documentation, special pathways for breakthrough and orphan devices, and emergency derogations. The Commission also estimates that the wider package could generate around EUR 3.3 billion in annual cost savings.

The Commission’s proposal would remove the maximum validity period for certificates, unless a notified body considers a limited validity period necessary on justified grounds. During certificate validity, notified bodies would carry out proportionate surveillance and periodic reviews instead of relying on repeated full recertification cycles.

It would also reduce PSUR frequency. Under the proposal, manufacturers of class IIb and class III devices would update the PSUR in the first year after certification and every two years afterwards, while class IIa manufacturers would update the PSUR when necessary.


Software: Parliament appears to keep the Commission’s lighter approach

One of the most sensitive parts of the Commission proposal concerns software. The Commission would rewrite MDR Annex VIII Rule 11 so that software generating an output that confers a clinical benefit would fall into Class I (lowest-risk devices) by default, unless it is used in more serious or critical clinical situations. In critical cases, it could move to Class III (Highest-risk devices); in serious or management-driving cases, to Class IIb (Medium-to-high risk devices) or Class IIa (Low-to-medium risk devices).

Schenk’s draft appears to preserve this architecture rather than reverse it. For software and AI-enabled medical technologies, that is highly significant. It suggests that Parliament’s rapporteur is not challenging the Commission’s basic decision to move away from an overly broad classification of medical software into higher-risk classes.

The practical consequence is clear: some digital health and AI-enabled tools could face a lighter route to market if their output supports clinical benefit without directly treating, diagnosing or driving decisions in serious or critical situations.

But the boundary will remain delicate. For manufacturers, the key question will be how “clinical benefit”, “drive clinical management” and “inform clinical management” are finally defined and applied by notified bodies and competent authorities.


Equivalence: more flexibility, but fewer shortcuts for high-risk implants

The Commission proposal makes the use of equivalent-device data more flexible. It would remove the current requirement for a contract with the manufacturer of the equivalent device granting access to technical documentation, provided the manufacturer can give clear evidence that the original clinical evaluation was performed under MDR-compliant requirements.

The Schenk draft appears to keep the removal of the contract requirement, but with a stricter condition: where a manufacturer relies on another manufacturer’s equivalent device under MDR Article 61(5), the equivalent device would need to have undergone its own clinical investigation. The route would also be closed for class III implantable devices.

This is one of the most important practical differences. The rapporteur is not rejecting the Commission’s attempt to reduce administrative friction, but he appears to draw a harder line for high-risk evidence. The message to industry is that equivalence may become easier procedurally, but not necessarily easier evidentially.

For professional users, this means clinical strategy becomes even more important. Companies relying on equivalence should not assume that the final reform will allow weak evidence packages. For class III implantables, the likely direction is even clearer: direct clinical evidence will remain central.


A new category of “niche devices”

The Commission proposal introduces special arrangements for breakthrough and orphan devices. These devices could receive expert-panel confirmation, priority conformity assessment, rolling review and advice on clinical or performance evidence. The Commission’s orphan-device definition is linked to conditions affecting not more than 12,000 individuals in the Union per year.

The Schenk draft appears to add a third category: “niche devices”. These would cover low-volume devices for a specific clinical use where no suitable alternative exists, or where losing access to the device would harm patient care.

This addition is politically and commercially important. It recognises that availability problems do not affect only rare-disease devices. Some devices may serve small but clinically significant patient groups, highly specialised procedures, paediatric uses, hospital-specific needs or low-volume applications where the economics of repeated certification are weak.

But it also creates a risk of complexity. The EU system may end up with breakthrough devices, orphan devices, niche devices, well-established technology devices and emergency or derogation routes. That could help address specific problems, but it could also create a crowded landscape of special categories that manufacturers, hospitals and notified bodies will need to interpret carefully.


PSURs: Parliament may recalibrate the Commission’s burden reduction

The Commission proposal reduces PSUR (Periodic Safety Update Report) frequency and moves notified-body review into surveillance activities. This is one of the clearest burden-reduction measures in the package.

Schenk’s draft appears to stagger that loosening. Two-yearly PSURs would apply mainly to implantable class IIb and class III devices. Class IIa and non-implantable class IIb devices would receive a lighter regime, but for class IIa the rapporteur appears stricter than the Commission by requiring a first PSUR within two years of certification.

This is a technically narrow but operationally important difference. It shows the draft trying to avoid both extremes: annual reporting for too many devices, but also a system where lower-risk devices disappear too far from structured post-market evidence.

For companies, the impact will depend on portfolio composition. Manufacturers with many class IIa products may face a more predictable initial PSUR obligation than under the Commission proposal. Manufacturers of higher-risk devices may still benefit from reduced frequency, but the surveillance link will remain important.


Certificates: no fixed validity, but safeguards for limited-data approvals

The Commission wants to remove the fixed maximum validity period of certificates. The logic is to avoid unnecessary renewals where continuing surveillance is sufficient. Notified bodies would still be able to impose conditions or limit validity in exceptional cases.

The Schenk draft appears to accept this reform, but with additional safeguards for breakthrough, orphan and niche devices certified on limited clinical data. In such cases, the initial certificate could be capped at five years, and renewal would depend on whether the manufacturer has delivered the required post-market follow-up.

This may become one of the central political compromises in the file. It allows earlier access for devices addressing unmet needs, but links that access to enforceable post-market evidence. The approach is closer to “conditional trust” than deregulation: reach the market sooner, but prove the device in real use.


What this means for the sector

The Schenk draft does not look like a frontal challenge to the Commission. It is better read as a managed-simplification text. It keeps the main competitiveness message: reduce unnecessary bureaucracy, make notified-body work more proportionate, support innovation and avoid losing clinically useful devices from the European market.

But it also adds caution where patient safety and evidence quality are most exposed. The most obvious areas are equivalence, special categories of devices, post-market evidence and conditional certification.

For manufacturers, the immediate task is not to wait passively for the final regulation. Companies should already map products against the possible new categories: software under Rule 11, class IIa and IIb PSUR obligations, devices relying on equivalence, orphan or low-volume products, and certificates that may become subject to conditions rather than repeated full renewal.

For notified bodies, the reform may reduce repetitive work but increase judgement calls. They may have more discretion, but also more responsibility to justify surveillance intensity, certificate conditions, use of equivalence and treatment of limited clinical data.

For hospitals and health systems, the potential benefit is earlier or continued access to devices that might otherwise disappear from the EU market. The risk is that special pathways become difficult to understand unless the final text is matched with clear MDCG guidance.

The political direction is therefore becoming clearer. The MDR and IVDR will not be dismantled. But the EU is trying to turn them from a rigid certification machine into a more risk-based, surveillance-driven and innovation-sensitive framework.

The decisive question now is whether Parliament and Council can simplify the system without creating another layer of complexity.
For Europe’s medical technology sector, that balance will determine whether the reform becomes a real competitiveness tool — or just another compliance exercise.