The Proposal aims to streamline the existing regulatory framework to address capacity constraints, reduce administrative burdens and enable more proportionate oversight across the lifecycle of medical devices and in vitro diagnostic medical devices. It forms one of three core pillars announced within the Commission’s Health package. (For further background, see our briefing Green light – Health Package & Food and Feed Package adopted by European Commission.) 

Revisions to MDR/IVDR classification rules

The Proposal adjusts multiple classification rules to ensure that there is alignment between risk and regulatory requirements. Some of the key changes proposed include:

• amending the classification rules to downgrade the risk class of particular device groups where the risk profile is deemed to be lower, such as reusable surgical instruments, certain software categories and active implantable devices;
• introducing a definition of “well-established technology devices” for devices with stable designs, a consistent history of safety, well-known clinical performance characteristics and a long history on the Union market; and
• providing that competent authorities shall coordinate when determining whether a specific device, category of device or group of devices should be classified as a medical device. The results of such coordination activities would also be made publicly available.

It is anticipated that these amendments will create a more predictable and less burdensome classification system for manufacturers.

Transition to a lifecycle-based oversight model

A key reform that has been introduced by the Proposal is the move away from a fixed five-year certification cycle for Notified Body certificates. Under the Proposal, these certificates would no longer expire automatically but would instead be maintained through periodic, risk-based reviews carried out by the Notified Body.

Under the Proposal, Article 61 of the EU Medical Devices Regulation 2017/745 (the “MDR”) would also be amended to allow a more proportionate clinical evaluation for “well-established technology devices”.

Modernisation of technical and clinical evidence requirements

The Proposal seeks to broaden the sources of acceptable clinical and non-clinical evidence to reflect scientific advances and to reduce unnecessary burdens. Specifically, the Proposal has suggested that ‘clinical data’ should include data generated through studies that are published in scientific literature, even where such literature is not peer-reviewed, thereby reducing reliance on manufacturer-generated studies.

However, clinical experience published in scientific literature would still have to be peer reviewed in order to qualify as ‘clinical data’. In addition, the Proposal suggests increasing acceptance of non-clinical evidence, such as in silico testing, bench testing and computational modelling. The conditions for demonstrating equivalence would also be eased, including the removal of the requirement for contractual access to another manufacturer’s technical file to claim equivalence.

In practice, this means that manufacturers may need to support an equivalence claim by using publicly available data and comparing it with their device to demonstrate that the devices are equivalent.

Streamlining compliance roles and documentation requirements

The Proposal removes detailed qualification requirements for the Person Responsible for Regulatory Compliance (“PRRC”) and significantly relaxes the availability requirements for SMEs relying on an external PRRC. It also aims to reduce administrative burden for distributors and importers which are engaged in repackaging and relabelling activities by removing the need for notified body certification and the obligation to provide the manufacture and the national competent authority with prior notice of any repackaging or relabelling.

The Proposal also limits the Summary of Safety and Clinical Performance (“SSCP”) obligations to devices subject to notified body technical documentation assessment. The Proposal seeks to enhance data management efficiency by enabling national distributor databases to access device information directly from the European Database on Medical Devices (“EUDAMED”). This enhanced transparency aligns with the EU’s broader efforts to strengthen data accessibility and regulatory coherence in the medical device sector.

Updated notified body and post market oversight processes

The Proposal aims to ease bottlenecks by streamlining notified body audits and post-market obligations. It provides that surveillance audits would occur only once every two years. Currently, on-site audits are required by notified bodies and remote audits have only been permitted on an exceptional, temporary basis during the COVID-19 Pandemic.

The Proposal introduced the possibility for notified bodies to replace on-site audits with remote audits, by allowing the Commission specify the modality of unannounced audits rather than simply the frequency. In addition, the Proposal indicates that for certain device categories notified bodies would move away from reviewing technical documentation at every surveillance cycle and instead review it only when concerns arise, reflecting a more risk-based approach to ongoing surveillance.

The Proposal further introduces adjustments to post-market surveillance requirements. Currently, under the MDR, manufacturers of Class IIb and III devices must update their periodic safety update report (“PSUR”) at least once every year. The Proposal would reduce this frequency by requiring one PSUR update in the first year following certification and then only every two years thereafter, thereby reducing administrative demands. The reporting deadline for certain serious incidents would also be extended from 15 to 30 days.

Collectively, these measures are intended to maintain effective regulatory oversight while alleviating operational pressures on both regulators and industry stakeholders.

Enhanced EMA support functions

The Proposal introduces a targeted amendment to Regulation (EU) 2022/123 to reinforce the European Medicine Agency’s (“EMA”) support for the expert panels on medical devices. This clarification strengthens the EMA’s organisational and scientific support functions for those panels, helping to improve the timeliness and consistency of the advice provided to notified bodies.

This amendment is limited to the EMA’s support function and does not change the regulatory responsibilities established under the MDR/ IVDR.  

List of critical medical devices

Under the Proposal, the EMA, through and with the input of the Executive Steering Group on Shortages of Medical Devices (“MDSSG”) will develop a methodology to identify the devices, or categories of devices, for which an interruption or discontinuation of supply could foreseeably result in serious harm or a risk of serious harm to patients or public health. The EMA, with the input of the MDSSG and with the approval of the Commission, will prepare, publish, and regularly update a list of critical devices.

The Commission or a national competent authority may require manufacturers of devices included on this list to share details about risks and vulnerabilities in their supply chains that could impact the availability of these devices.

What’s next?

The Proposal is now before the European Parliament and Council under the ordinary legislative procedure. While there is no fixed deadline for its adoption, it is anticipated that 2026 will be a key year for legislative progress in this area, given the political priority attached to addressing MDR/ IVDR and the key role that this plays within the broader Health Package. It is also to be expected that this file will come under some focus during the Irish Presidency of the Council of the European Union, during the second half of this year. 

The Proposal should also be read within the context of the recent publication of the Digital Package on Simplification (the “Omnibus Package”).  

On 19 November 2025, the European Commission published the Omnibus Package. This Package aims to streamline and clarify certain aspects of the EU’s data and digital legislation. Some of the key changes are in the GDPR, Regulation (EU) 2024/1689 (the “AI Act”) and the EU data acquis. For more information on the Omnibus Package, read our briefing: Digital Package on Simplification.  

A key change in the Omnibus Package for manufacturers of medical devices and in vitro diagnostic medical devices is the possible extension of the timeframe for compliance with the obligations for high-risk AI systems under the AI Act. The general date of application of AI Act is 2 August 2026. However, the timeline for compliance with obligations for high-risk AI systems is proposed to be extended to align with guidance (to be) provided by the Commission. If this change is adopted, the compliance obligations for those medical devices and in vitro diagnostic medical devices which are considered high-risk AI systems in accordance with Article 6(1) of the AI Act, will apply a maximum 12 months following the adoption of a decision by the Commission that “adequate measures in support of compliance” are available ( i.e. 2 August 2028). 

Viewed together, these structural reforms signal a broader recalibration of the MDR/ IVDR regime, one that will continue to evolve as the legislative process progresses and guidance becomes available.

For more information, please contact our Life Sciences Group.

With thanks to Aoife O’Malley for her contribution to this briefing.