Extensive Proposal to Amend Medical Device Regulations
The European Commission released, just before Christmas (16 December 2025), its long-awaited proposal to amend the regulatory framework for medical devices. This MDR/IVDR amendment package was published alongside the proposal for a new Biotech Act. Earlier in November, the Commission had already published a broad set of amendments to digital legislation, the so-called Digital Omnibus. The MDR/IVDR proposal also includes several unexpectedly significant changes regarding the regulation of medical devices incorporating artificial intelligence.
The amendment package is quite extensive, and specialists will be analysing it well into the spring. Major proposed changes concern, among other things, conformity assessment and clinical investigation applications. In addition, the proposal introduces definitions and special procedures for breakthrough devices and orphan devices. The Commission also proposes addition of so-called regulatory sandboxes, as introduced in the AI Act, into the medical device framework.
Below are selected key elements of the proposal. A more detailed analysis—which will be updated along the winter—is available on our members’ pages. Members will also have the opportunity to hear more about the proposal in our event on 4 February 2025, when we welcome Erik Vollebregt (Axon Lawyers), and Ajda Mihelčič from COCIR, as well as representatives from Fimea and the Ministry of Social Affairs and Health.
Event for members
4.2.2026 EU Medical Device Regulation (MDR and IVDR): Latest Developments and Expert Analysis
Come and hear the latest analysis of the suggested changes in EU regulation, discussion led by Erik Vollebregt and Nelli Karhu.
Conformity Assessment
The proposal would replace fixed term certification with a continuous system featuring periodic, risk-based assessments. If the device’s safety data allows, the audit interval could be extended from one to two years.
Significant changes are proposed to technical file sampling: instead of the current system, the number of technical files subject to review would be substantially reduced for MD class IIa and IIb devices, as well as IVD class B and C devices. For point-of-care IVD tests (near patient testing), the assessment of technical documentation would be aligned with other professional use IVDs, so each individual technical file of B and C-class point-of-care tests would no longer need separate assessment. These changes are expected to bring considerable time and cost savings.
For sterile class A IVD devices, the involvement of a notified body would no longer be required at all. For reusable surgical instruments (Ir-class devices), conformity assessment would be modified so that if the manufacturer has comprehensively and appropriately applied harmonised standards, assessment by a notified body would not be necessary.
Onsite audits could more often be replaced by remote audits, and the number of unannounced audits would be reduced.
Procedures related to change management would be simplified. The notified body and manufacturer could also draw up a predetermined change control plan for certain changes.
Fees
The Commission proposes substantial fee reductions for small and microenterprises. Microenterprises and orphan devices would receive at least a 50% reduction; small enterprises at least 25%. However, financing this model is challenging, given that most of the clients of notified bodies are SMEs. It will be important to ensure that the system does not, for financial reasons, concentrate notified body activity into just a few large entities, which could negatively impact pricing and availability.
Artificial Intelligence and Medical Devices
The Digital Omnibus published in November already included positive changes for AI-enabled medical devices. It clarified the relationship between the AI Act and MDR/IVDR by stating that MDR/IVDR take precedence in case of conflict. It also clarified issues relating to clinical research using AI and proposed delaying compliance deadlines until necessary standards and guidance are available.
However, the MDR/IVDR amendment contains a major surprise: the proposal would move medical devices from Part A to Part B of Annex I of the AI Act. As a result, medical devices would no longer be subject to the full set of high-risk AI system requirements. The Commission would retain the power to define applicable requirements later via secondary legislation.
Breakthrough and Orphan Devices vs. WET
A significant new proposal is to incorporate breakthrough device and orphan device definitions and associated special procedures into the regulatory framework, aiming to accelerate market access and improve patient access to high value innovations.
Manufacturers of devices granted breakthrough, or orphan status would be entitled to expert panel advice on clinical development strategies or on appropriate preclinical or clinical data. Notified bodies would be required to prioritise such devices and consider the special status and panel advice in conformity assessment.
For legacy orphan devices placed on the market under previous Directives, the proposal would allow continued placing on the market beyond current transitional deadlines, provided no significant changes are made.
Well established technologies (WET) could benefit from simplified conformity assessment procedures relative to their risk class. In addition, WET status would remove the requirement to provide an implant card for certain devices.
Single-use and Reprocessing
In the future, single-use status for MDs would have to be justified, and non-single-use devices should be re-processable in accordance with the manufacturer’s instructions.
Clinical Evaluation
The definition of clinical data would be updated and clarified. Various types of in-silico modelling would be more explicitly recognised as acceptable clinical evidence. Requirements for demonstrating equivalence would also be eased.
Clinical Evaluation and Performance Evaluation Consultation Procedure (CECP, PECP)
The CECP under MDR Article 54 would be limited to class III implantable devices, although the Commission could later extend this to other device types via implementing acts.
The proposal would also further limit the use of CECP. For example, CECP would not generally be required for renewal of an MDR certificate, nor in situations where the device is designed on the basis of an equivalent device already on the market and the manufacturer can demonstrate that the benefit–risk ratio has not changed for the worse. Use of harmonised standards or common specifications developed for that device type could also exempt it from CECP.
The corresponding IVD performance evaluation consultation procedure (PECP) would be abolished entirely. However, manufacturers of class C and D IVDs could seek advice from the expert panel.
Clinical Investigations
Article 82 on “other clinical investigations” would be deleted.
Several other changes are proposed, the most significant being the introduction of a joint submission option for combination studies involving medicines, MDs and/or IVDs. If a study involves the investigation of both medicinal products and MD and/or IVD devices, the sponsor should, if they so wish, be able to submit a single joint application.
Procedures for IVD performance studies would be simplified: studies involving only routine blood draws from non-risk groups would no longer require authorisation. Nor would studies using leftover specimens for companion diagnostics require notification. The proposal also clarifies that an application for a performance study should be addressed only to the Member State where samples are collected.
Notified Bodies
The proposal introduces, in addition to the abovementioned certification and audit changes, clarifications to organisational requirements and further measures to harmonise and streamline notified body operations. The aim is to better manage and anticipate the cost and duration of conformity assessments—particularly for SMEs—and to increase predictability and transparency. Structured dialogue between manufacturers and notified bodies would be formalised.
Classification
Several changes are proposed to MDR Annex VIII classification rules (rules 2, 6, 7, 8, and 9). Many of the proposed changes are technical or clarifying—for example updates to references to other legislation such as nanotechnology and SOHO products. Blood bag classification is also clarified.
The largest proposed change affects software: MDR rule 11 would be rewritten to better align with IMDRF recommendations. Although some medical device software (MDSW) might move back to class I, it is emphasised that this is only a proposal and is likely to be further modified during the legislative process. Manufacturers should not change existing compliance plans yet.
No changes are proposed to IVD classification rules, despite requests for better software related provisions.
As previously, Manufacturers would remain responsible for classification, but procedures for resolving complex classification issues would be improved to enable faster and clearer EU level decisions.
Combination Products
Changes are proposed to consultation processes for combination products. Where an MD incorporates an ancillary medicinal substance or a substance of human origin (SOHO), deadlines for medicinal authority consultation would be shortened. In addition, the consultation process under MDR Annex IX section 5.4 would be removed for certain substances (devices, or their products of metabolism, that are systemically absorbed by the human body in order to achieve their intended purpose).
For companion diagnostic IVDs, the consultation process would be clarified, emphasising that medicinal authorities should not duplicate notified body work. This should, hopefully, narrow the process and could hopefully affect (reduce) the respective fees.
For devices combining MD and IVD elements, the scope of the Regulations and the conformity assessment process applicable to such devices would be clarified.
Reporting, Documentation and Digitalisation
Reporting and documentation requirements would be simplified in several ways. Technical documentation and EU declarations of conformity could be provided electronically. Certain labelling requirements could also be met digitally. Instructions for use for point-of-care tests could be provided electronically, similar to other professional use IVDs. The proposal also refers to electronic and digital formats for implant cards.
The requirement for periodic safety update reports (PSURs) would be reduced, and notified bodies could assess PSURs as part of surveillance activities rather than separately. Reporting deadlines for incidents not involving public health threats, death, or serious deterioration of health would be extended from 15 to 30 days.
Where an incident includes a cybersecurity breach, the information would also be forwarded via EUDAMED to relevant cybersecurity authorities. Cybersecurity requirements would be more explicitly included in Annex I general safety and performance requirements. Similarly, the Digital Omnibus also proposes harmonisation of cybersecurity related reporting (“one reporting mechanism”).
SSCPs would be required only for class II devices and class IIb implantable devices. Other implantable device classes would no longer require SSCPs.
For IVDs, SSPs would be required for companion diagnostics, class D devices, and class C self testing devices. SSCPs/SSPs would remain part of the technical documentation submitted to the notified body and uploaded to EUDAMED, but notified bodies would no longer be required to validate them.
Manufacturer Responsibilities – Article 10
Article 10 would undergo major restructuring; however, deleted passages do not automatically indicate removed obligations. Most changes merely remove redundancies where the same requirement appears in multiple sections. However, some real changes are also included—for example, MDR Article 10(16) (IVDR Article 10(15)) would be deleted, though the underlying product liability directive obligations would remain in force.
Person Responsible for Regulatory Compliance (PRRC)
Detailed references to specific qualifications and work experience would be removed. Micro and small enterprises would still need a PRRC (internal or external), but the requirement for the PRRC to be permanently and continuously available would be removed. The PRRC’s name would no longer be published in EUDAMED.
Repackaging and Translations (Article 16)
The requirement for an appropriate quality system for entities performing these activities (e.g. distributors) would remain, but the previous requirement for a notified body certificate and authority notification would be removed.
In-House Manufacturing by Healthcare institutions
Changes are proposed for both MDR and IVDR. The proposals are not identical. According to the proposal, both MD and IVD inhouse devices could, in certain situations, be transferred between healthcare units—for example for public health reasons or crisis situations. However, only for IVDs would the requirement be removed that no equivalent CE marked device is available.
International Dimension
A new requirement is introduced for the Commission to promote international cooperation and global regulatory harmonisation. The Commission could also support third countries in building regulatory capacity. This includes strengthened engagement with IMDRF, the Medical Device Single Audit Program (MDSAP), and other bilateral or multilateral recognition mechanisms.
Short Term Changes and Further Information
The Commission has also published a model for handling breakthrough devices under current legislation (MDCG guidance) and a draft implementing act on notified bodies. These are also worth reading—they are separate from the broader amendment package.
Conclusion
Although analysis of the proposal is still ongoing, it is clear that the Commission has seriously attempted to address many of the challenges raised by the sector while preserving, and even strengthening, important aspects of patient safety.
Despite active discussion and quick initial commentary on social media, the details require careful study. While optimistic timelines exist, the legislative process may still take several years, with debate and opposition likely. We will continue working on the proposal at Healthtech Finland and will provide feedback to the Commission.
Further information
- The “heavy reading” — the amendment proposal itself — can be found here (note: the Articles of the MD and IVD Regulations are in one file, and the Annexes in another):https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en
- For a more concise description of the amendments and the estimated cost savings, the Commission’s shorter summary is here (some details may be missing): https://health.ec.europa.eu/document/download/94299481-f705-4918-9c64-8fd1d2ac2cb5_en?filename=md_swd-2025-1050_en.pdf
- More information and the full package: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en#latest-updates
- Call for feedback on the implementing act concerning Notified Bodies: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14471-Medical-devices-uniform-application-of-the-requirements-for-notified-bodies_en
- Breakthrough guidance: MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746
