In a pre-Christmas gift, the European Commission has adopted a proposal to simplify Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR): Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices. The key elements of the revisions are summarized in a factsheet and in a questions and answers document.
The proposal aims to streamline and future-proof the regulatory framework. Its main objective is to simplify the applicable rules, reduce the administrative burden on manufacturers, and enhance the predictability and cost-effectiveness of the certification procedure. At the same time, the proposal seeks to preserve a high level of public health.
The proposal and additional recent announcements are important changes for the industry and institutions and could significantly reduce the administrative—and cost—burden for both companies and authorities.
Background
The implementation of the MDR and IVDR has been problematic, as all stakeholders have found it difficult to adapt to the new legal requirements, and timelines have been tight. Despite extensions to the timelines, delays in companies obtaining CE marks continue and there are criticisms that the rules are stifling innovation and concerns about the impact on patients as devices are withdrawn from the market.
In October 2024, the European Parliament called on the European Commission to amend the legislation to address these criticisms. While this did not have binding legal force, in 2025, the European Commission conducted a consultation and a call for evidence to better understand how the regulations should be amended.
After analyzing the responses and comments received, on December 16, 2025, the Commission proposed a package of amendments to the legislation to address some of the concerns raised.
Key provisions
Some of the key proposals include:
Simplified Conformity Assessment Procedures
- Validity of certificates: The five-year validity of certificates would be removed. Instead, notified bodies will carry out periodic risk-based reviews.
- Clinical evidence: There will be more flexible conditions for relying on clinical data from an equivalent device and expansion of the possibility to demonstrate safety and performance based on non-clinical data.
- Well established technologies: A definition of “well-established technology device” is introduced, and these devices will be subject to more proportionate requirements. These are devices that belong to a generic device group, that have a simple, common and stable design, are not associated with safety issues, have well-known clinical performance characteristics, and a long history of use in the European Union.
- Classification: Some classification rules are adapted, which should result in the possibility of lower risk classes for some devices, including software.
These changes aim to reduce the burden on both notified bodies and manufacturers and reflect a more risk-based approach to the conformity assessment procedure.
Relationship with Notified Bodies
- Structured dialogue: A legal basis for notified bodies and manufacturers to conduct a structured dialogue will be introduced.
- Fees: There will be fee reductions for micro and small manufacturers and for orphan devices.
- Coordination: The authority responsible for notified bodies will have an “ombudsperson” role in case of disputes between manufacturers and notified bodies.
- Audits: There will be greater use of remote audits, less frequent surveillance audits, and unannounced audits limited to “for-cause”.
These will be welcome changes for companies. The proposal on structured dialogue in particular seeks to address a common area of complaint, as under the current provisions, notified bodies have not been able to provide advice to companies when questions have arisen. This proposal could therefore provide an important avenue for companies to engage with notified bodies.
Although not released as part of this proposal, there was also a new Implementing Act on Notified Body Procedure released for consultation on December 15: Uniform application of the requirements for notified bodies. This sets out standard information on costs and maximum timelines for conformity assessments, which seek to standardize the assessment process between notified bodies.
Reduced Administrative Burden
- Reduced reports: The proposal reduces the scope of devices for which the manufacturer must provide a summary of safety and clinical performance, reduces frequency of periodic safety update reports (PSURs), and provides longer reporting timelines for serious incidents.
- Changes after certification: Notified bodies must distinguish between changes regarding the quality management system or the device that manufacturers can implement without prior notification, without prior approval or only after approval by the notified body. Where appropriate, the notified body and manufacturer can agree on a predetermined change control plan.
- PRRC: The proposal removes the detailed qualification requirements for the person responsible for regulatory compliance (PRRC).
Again, these provisions will be welcomed by companies and should lead to less administrative requirements once the device is on the market, and ultimately, less costs.
Provisions for Specific Devices
- Breakthrough and orphan devices: Criteria for breakthrough devices and orphan devices will be introduced, which will be subject to priority and rolling review. In addition, new Guidance on Breakthrough Devices was published on December 15: MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746. “Breakthrough Devices” are those that introduce a high degree of novelty and that are expected to provide a significant positive clinical impact for a life-threatening or irreversibly debilitating disease, either by offering a significant positive clinical impact or fulfilling an unmet medical need. “Orphan devices” are those intended for the treatment, diagnosis, or prevention of a disease in no more than 12,000 individuals in the EU per year, and where there are insufficient available alternatives, or the device is expected to provide a clinical benefit compared to available alternatives.
- AI devices: Amendments to the Artificial Intelligence Act (Regulation (EU) 2024/1689) will mean that requirements for high-risk AI systems are streamlined for device manufacturers.
- In-house exemption: The conditions for the manufacture and use of IVDs within health institutions are made more flexible, including permitting transfer between institutions if this is in the public interest. Further, the proposal will bring central laboratories manufacturing and conducting tests exclusively for clinical trials within scope of the in-house exemption.
- Clinical trials: For combined studies involving devices and medicinal products, the sponsor may submit a single application, triggering a coordinated assessment.
Use of IVDs within clinical trials has been a major administrative burden for medicines trials, not least because, at present, separate applications must be made for the medicines and device/IVD elements, leading to delays and a lack of harmonization. The proposals on combined device/IVD and medicinal products trials are likely to receive broad support, as this was a key area of complaint raised during the Commission consultations.
Next Steps
The proposal will now enter the legislative process and be considered by the European Parliament and Council before (hopefully) agreement and adoption, although the details are likely to be amended during this process. It is unclear how long this will take, but there is pressure from all sides to implement changes quickly to address some of the difficulties with the implementation of MDR and IVDR.