A European Perspective #1
In December 2025, the European Commission published a proposal to amend the EU Medical Device Regulation (EU) 2017/745 (MDR) and In-Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). The proposal represents one of the most significant planned reforms of the EU medical device regulatory framework since the regulations entered into force. It introduces a broad range of measures aimed at strengthening the competitiveness of the EU market (including through a reduced regulatory burden), promoting innovation, and improving device availability for patients.
The broad scope of the proposed changes requires a detailed analysis of their business impact. While TaylorWessing’s article here provides a more comprehensive overview of the proposals, this executive summary highlights selected key changes from the perspective of medical device manufacturers:
- Overhaul of certificate validity: Under the current framework, conformity certificates are issued for a maximum of 5 years. The proposal would remove this time limit, introducing certificates with no fixed expiry, unless in exceptional cases where the notified body considers it necessary on duly justified grounds. Instead, notified bodies would conduct appropriate risk-based surveillance activities and periodic reviews. This represents a significant regulatory shift aimed at reducing the recertification burden on manufacturers and addressing certification bottlenecks and supply shortages.
- Streamlined clinical evidence requirements: The proposal introduces significant changes to the current clinical evidence framework. This includes, in particular, the introduction of a new category of “well-established technology devices”, covering long-established technologies with well-known safety and performance profiles. Such devices would be exempt from certain obligations, such as the requirement to prepare a summary of safety and clinical performance, and would benefit from simplified conformity assessment procedures and regulatory derogations (e.g. assessment of technical documentation for one representative device per generic device group). The proposal also allows for broader reliance on equivalence to demonstrate conformity and broader recognition of additional clinical evidence sources (such as in silico testing).
- Regulatory relief for manufacturers: The proposal includes several measures aimed at reducing compliance burdens. These include changes to the framework for the person responsible of regulatory compliance (PRRC), notably removing detailed qualification requirements and allowing outsourcing for micro and small enterprises. It also introduces a new, proportionality-based framework for quality management systems (QMS), replacing current prescriptive requirements. In addition, the proposal provides for significant simplifications in post-market surveillance (including relaxed PSUR requirements) and incident reporting.
- New classification rules for medical device software (new Rule 11): The proposed amendments introduce a revised Rule 11 under which software intended to generate outputs conferring a clinical benefit and used for diagnosis, treatment, prevention, monitoring, prediction, prognosis, compensation or alleviation of a disease or condition would be classified as Class I by default, with escalation to higher classes depending on the severity of the clinical situation addressed. While the escalation criteria may raise practical challenges, this change could significantly broaden the scope for self-declared conformity for software
- New rules for single-use devices and reprocessing: The current reprocessing framework is to be replaced by a revised regime that effectively reverses the regulatory logic. Manufacturers would be required to justify single-use claims and provide adequate information on reprocessing for devices not intended to be single-use. Full refurbishment of single-use devices may also become possible, with the entity performing such refurbishment being considered the manufacturer.
- Breakthrough and orphan device pathways; regulatory sandboxes for innovative devices: The proposal also introduces brand new sections, aimed at promoting innovation and availability. These include dedicated pathways for breakthrough devices (offering significant clinical advantages in critical areas) and orphan devices (addressing rare conditions), as well as the possibility to establish regulatory sandboxes, i.e. controlled environments in which certain MDR requirements may be temporarily adapted or waived for innovative devices.
The proposal is currently at an early level of the legislative process (preparatory phase in the European Parliament). This means that significant changes are possible, and that formal adoption is unlikely before 2027.
Key Takeaways
Medical device companies should closely monitor legislative developments and consider initiating internal gap assessments against the proposed framework. Given the scale of the proposed changes, a comprehensive legal analysis tailored to the specific product portfolio will be required.
Such analysis should include a review of the current portfolio and an assessment of risks and opportunities, particularly in the light of changes to the certification and classification regimes, including identification of devices that may benefit from simplified clinical and post-market requirements.
Particular attention should be paid to specific product categories, such as single-use devices or medical device software, where the proposed changes are likely to have the most significant impact. Companies should also assess whether new pathways and innovation-focused mechanisms may be applicable.
