MDR and IVDR Amendments: What actually changes – and Why it matters.

The proposed amendments to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)

The proposed amendments to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) are often described as simplification or deregulation. That description is inaccurate. The proposal is better understood as a targeted correction of structural problems that have distorted regulatory effort, particularly for small and medium-sized manufacturers, without improving patient safety.

The recitals themselves are explicit about where burden has become disproportionate, where scientific progress has not been reflected in the law, and where procedural requirements have become barriers rather than safeguards.

What follows is ordered by practical impact, not by where the changes appear in the regulation.

1. Clinical evidence and equivalence: removal of the technical documentation deadlock

(Recitals 38 and 39; Article 61; Article 2; Annex XIV)

The most consequential change in the proposal concerns clinical evidence and equivalence.

Recitals 38 and 39 explicitly acknowledge that the existing requirement to have access to the technical documentation of an equivalent device has rendered equivalence largely unusable in practice, particularly outside corporate groups. This has prevented scientifically valid clinical data from being used, even where extensive post-market experience and published clinical evidence exist.

The proposal removes this structural barrier. Through amendments to Article 61, supported by changes to Article 2 and Annex XIV, clinical data from equivalent devices may be used without mandatory access to the equivalent manufacturer’s technical documentation, provided that equivalence can be scientifically substantiated using available data sources and state-of-the-art knowledge.

The burden shifts from contractual access to proprietary documentation to methodological robustness, transparent justification and appropriate management of residual uncertainty, including post-market clinical follow-up where necessary.

For SMEs, this is transformative. It allows legitimate use of published literature, real-world evidence and post-market data without requiring commercial leverage over competitors. This does not lower the evidentiary bar; it removes a barrier that was unrelated to safety and strongly correlated with company size.

2. New Approach Methodologies and non-clinical evidence

(Recital 37; Article 61; Article 2; Annex XIV)

Recital 37 explicitly recognises the scientific and regulatory validity of New Approach Methodologies for demonstrating safety and performance. It acknowledges advances in science and technology that enable non-animal, non-clinical methods — including in-vitro, in-silico, computational and mechanistic approaches — consistent with the principles of replacement, reduction and refinement set out in Directive 2010/63/EU.

This recognition is not abstract. It is operationalised directly in Article 61, which expands the circumstances in which safety and performance may be demonstrated on the basis of non-clinical data alone, provided the manufacturer justifies why clinical data are not necessary in the specific context. The scope of clinical data in Article 2 and the structure of clinical evaluation in Annex XIV are aligned accordingly.

The obligation to demonstrate conformity with Annex I remains unchanged. What changes is that manufacturers are no longer forced into traditional clinical investigations by default where scientifically valid non-clinical methodologies provide equivalent or better assurance.

For SMEs, this legitimises evidence strategies that are faster, more controllable and proportionate to the technology, rather than forcing replication of legacy clinical models simply because they are familiar.

3. Risk classification corrections: aligning class with inherent risk

(Recital 29; Annex VIII; Article 1 amendments)

Recital 29 explicitly states that some existing classification rules do not accurately reflect the inherent risk of certain devices and should be adapted to result in a lower risk classification.

The recital gives concrete examples, including reusable surgical instruments and certain accessories for active implantable medical devices, where risk has been overstated through association or reusability rather than inherent characteristics.

This recital is implemented through targeted amendments to Annex VIII via Article 1 of the proposal. These changes result in lower risk classification for specific device categories where justified.

For SMEs, a lower classification can materially change regulatory cost, notified body involvement and time to market. Importantly, this does not alter the General Safety and Performance Requirements in Annex I. It aligns classification with actual risk rather than historical regulatory caution.

4. Removal of automatic clinical evaluation consultation for devices administering or removing medicines

(Recital 28; Article 54)

Recital 28 addresses the disproportionate application of mandatory clinical evaluation consultation for devices that administer or remove medicinal products.

The recital recognises that the consultation procedure has often duplicated assessments already performed for authorised medicinal products and, in many cases, added time and cost without improving safety, particularly for established device–medicine combinations.

This is implemented through amendments to Article 54, which remove the automatic requirement for consultation in all cases. Consultation is retained where the device introduces new or unresolved clinical questions relating to the medicinal product’s safety or performance, but it is no longer a default procedural trigger.

Clinical evaluation obligations remain unchanged. What is removed is duplication that disproportionately affected smaller manufacturers relying on established medicinal products.

5. Certificate validity and lifecycle-based conformity oversight

(Recital 34; Article 56; Annex VII)

Recital 34 recognises that fixed certificate validity periods and repeated renewal cycles have created significant administrative burden without proportionate safety benefit, particularly for stable devices with extensive post-market experience.

The proposal removes the fixed five-year maximum validity period in Article 56. Conformity is maintained through periodic review during certificate validity, with review intensity linked to risk, changes, post-market signals and evolution of the state of the art. Amendments to Annex VII support this risk-based approach.

Notified bodies retain the ability to limit certificate duration and impose conditions where justified. Oversight is maintained, but applied continuously rather than through time-driven reassessment events.

For SMEs, this reduces exposure to repeated, near-full reassessments that can destabilise small organisations even where products are stable and well-performing.

6. Fee reductions for micro and small enterprises

(Recital 27)

Recital 27 explicitly recognises that conformity assessment fees can be disproportionate for micro and small enterprises and may act as a barrier to market access.

The proposal provides for reduced fees for micro and small enterprises, defined in accordance with the EU SME definition based on employee numbers and turnover or balance sheet totals. The reduction applies to notified body fees and does not reduce regulatory obligations or evidentiary requirements.

This establishes proportionality in fee-setting without diluting oversight — a change that matters materially to early-stage and niche manufacturers.

7. Removal of low-value procedural duplication

(Articles 15 and 32; Annexes II and III)

Several amendments remove procedural duplication that consumed notified body and manufacturer capacity without strengthening safety assurance. These include clarification of availability requirements for the person responsible for regulatory compliance, streamlining of Summary of Safety and Clinical Performance validation, simplification of relabelling and repackaging obligations, and integration of PSUR review into notified body surveillance.

Annex I requirements are unaffected. The change is procedural, not substantive.

8. Digital technical documentation

(Recital 19; Article 10; Annexes II and III)

The proposal explicitly allows technical documentation to be submitted electronically, including in structured, machine-readable formats, provided traceability, version control and human readability are maintained.

For SMEs with limited regulatory resources, this reduces friction, rework and dependency on manual documentation processes.

9. Cybersecurity integration into safety surveillance

(Recital 44; Articles 87a MDR and 82a IVDR; Annex I)

Cybersecurity is integrated into the medical device safety framework through new reporting obligations for actively exploited vulnerabilities and severe cybersecurity incidents, routed via EUDAMED to national CSIRTs and ENISA. Cybersecurity is explicitly reinforced within Annex I.

This applies proportionately and does not introduce new classification categories.

What this means overall

(Annex I overarching intent)

The proposal does not lower safety or performance expectations. It corrects specific structural failures, aligns regulatory effort with inherent risk and scientific reality, and removes scale-dependent disadvantages that disproportionately affected small and medium-sized manufacturers.

For SMEs in particular, the changes around equivalence, non-clinical evidence, fee proportionality and procedural duplication are not marginal. They address barriers that had nothing to do with patient safety and everything to do with organisational scale.