EU Commission Proposes Reform of the Medical and In Vitro Device Regulations

Following the identification of several key challenges in the application of the Medical Device Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR), the EU Commission has now published its proposal setting out various targeted revisions to both frameworks. In this article, our Life Sciences Regulatory team provides an overview of the proposed amendments.

What you need to know

• The EU Commission’s proposal to simplify the rules for medical devices and IVDs forms part of a package of measures to improve the health of EU citizens, while ensuring the long-term resilience and competitiveness of the health sector.
• The proposal introduces reforms that seek to simplify regulatory requirements, reduce costs and the administrative burden, and promote innovation and digitalisation in the medical device sector.
• The proposed amendments will now be submitted to the European Parliament and Council for consideration and may be revised further in advance of adoption.

The EU Commission published a proposal for a targeted revision of the MDR and IVDR on 16 December 2025. The proposal follows a call for evidence launched earlier this year seeking feedback from industry stakeholders regarding the key issues faced under the current regulations. This feedback identified unpredictable certification timelines, disproportionate conformity assessment requirements and unnecessarily high costs and burdens as core areas for improvement. In light of this feedback, the proposal aims to streamline and future-proof these EU regulatory frameworks by simplifying the applicable rules, easing the administrative burden on manufacturers and improving the predictability and cost efficiency of the certification process by notified bodies.

The main features of the proposal are arranged under a number of topic headings, with important proposed measures including:

Simplification and proportionality

• The removal of the maximum 5-year validity period for device certificates, with notified bodies empowered to carry out periodic reviews that are proportionate to the risk posed by the device, while the certificate remains valid.
• Updates to device classification rules, potentially resulting in lower classifications, and more proportionate regulatory requirements for certain devices. The proposal offers examples of reusable surgical instruments and accessories for active implantable devices as devices that would benefit from this reclassification under the revised text, and possible updates to classification rules applicable to software devices should be monitored closely by digital health stakeholders.
• The concept of the ‘well-established technology device’ to be placed on a legislative footing using a formal MDR definition. Under the proposal, medical devices falling within this category would be subject to more proportionate requirements.

Reduction of administrative burden

• A reduced scope for devices requiring a summary of safety and clinical performance (SS(C)P), and a less frequent obligation to update the periodic safety update report (PSUR) of a device.
• Streamlined change notification procedures with notified bodies.
• An extension of the period for the reporting of serious incidents from 15 to 30 days where these do not relate to any threat to public health, death or the serious deterioration of health.

Innovation and availability of devices for special patient groups or situations

• The introduction of criteria for designation as breakthrough devices and orphan devices, with access to expert panel advice and priority/rolling reviews.
• Extended market access for certain orphan devices CE marked under the former Directives, subject to conditions.

Predictability and cost-efficiency of certification

• The introduction of a legal basis for structured dialogues between notified bodies and manufacturers.
• Reduced involvement of notified bodies in the conformity assessment of devices falling into lower and medium-risk classes (device class IIa and IIB and IVD classes B and C) and allows notified bodies to conduct remote audits in place of on-site audits.

Coordination within decentralised system

• Measures to provide for increased coordination among competent authorities regarding the qualification of a product and the classification of a device, such as the codification of the ‘Helsinki procedure’, and an enhanced role for expert panels.
• The composition and role of expert panels to be broadened to allow for increased capabilities to provide scientific, technical, clinical and regulatory advice to the Commission, Member States, the MDCG, notified bodies and where appropriate, manufacturers.

Further digitalisation

• The digitisation of several aspects of compliance. For example, manufacturers would be permitted to draw up their technical documentation in digital form, and the Declaration of Conformity and certain labelling information could also be provided in digital form.

International cooperation

• New provisions recognising the importance of global regulatory harmonisation, and the roles of the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Programme (MDSAP).

Interplay with other EU frameworks

• The overlap with ‘high-risk AI system’ (HRAIS) requirements under the AI Act would be addressed further, with most HRAIS requirements not applying in the case of medical devices.
• Cybersecurity to be expressly referred to in Annex I (General Safety and Performance Requirements) of the MDR and IVDR, and enhanced reporting requirements for ‘serious incidents’ under the EU Cyber Resilience Act.

Comment

These proposed new measures signal the potential for widespread reform of the EU device and IVD regulatory regime in the EU. The EU’s proposal will now be submitted to the European Parliament and the Council for consideration and adoption under the ordinary legislative procedure, so further revisions are possible. Although likely welcomed by industry as a positive if not long awaited step towards a more efficient and proportionate regulatory system, these proposals also require further monitoring by manufacturers, with the planned end result being a set of new requirements that will require further investment to ensure compliance.

For more information and expert advice on the application of the MDR and IVDR, please reach out to a member of our Life Sciences Regulatory team.

The content of this article is provided for information purposes only and does not constitute legal or other advice.