EU Commission proposes a targeted revision of the medical devices regulations

On 16 December 2025, the European Commission proposed a targeted simplification of the current rules for medical devices to make them easier, faster and more effective and further promote competitiveness, innovation and a high-level of patient safety in this key sector.

What are the main objectives of the simplification and what is changing from the existing rules?

The main objectives of the simplification include:

Reduced administrative burden and enhanced coordination among regulatory actors through:
- more efficient reporting obligations:
- simpler rules
- more streamlined procedures for all key players, including for small and medium-sized enterprises.
More proportionate and targeted requirements by making the conformity assessment procedures
- more predictable
- focused and
- balanced, especially for low and medium risk devices and those for small patient populations, such as for children and rare diseases patients.
Support for innovation and the development of breakthrough technologies, with targeted support such as early expert advice and regulatory sandboxes.
Enhancing the legal certainty, predictability and cost-efficiency of certification by:
- introducing clearer definitions
- making the classification rules more proportionate and
- facilitating the use of real-world evidence.
Increased digitalisation by
- extending the possibility to provide electronic instructions for use,
- allowing digital labelling of information and
- the digitalisation of tools and conformity assessment procedures.
Improved coordination at EU level through more coordinated and streamlined oversight of notified bodies, and the provision of EU-level scientific, technical, regulatory and administrative support through stronger involvement of experts panels and the European Medicines Agency (EMA).
Reinforcing international cooperation by empowering the Commission to determine EU participation in high-standard international cooperation and information sharing mechanisms with reliable partners and strengthened uptake of international guidance.

What is the revised proposal?

The revised proposal is presented in the form of a regulation to reduce and simplify the rules on medical and in vitro diagnostic devices.

Are there any documents to support the proposal?

Yes, there are two staff working documents support the proposal as follows:

What is the aim of the proposal?

The aim of the proposal is to:

simplify EU rules for medical devices,
support the digitalisation of procedures, and
offer a modern, adaptive framework so that companies can respond to changing market conditions and patient needs.

Where are the key elements of the proposal summarised?

The key elements of the revision are summarised in a factsheet and in a Q&A document.

Who has the proposal been submitted to?

The proposal has been submitted to the European Parliament and the Council.

What has to happen in order for the proposal to become binding Union law?

To become binding Union law, the co-legislators need to adopt the text by ordinary legislative procedure.

An overview of this procedure is available in the European Parliament website.
You can follow the development of the legislative decision-making process on the “Legislative Observatory” of the European Parliament.

What are the main benefits expected for patients and healthcare professionals?

Most importantly, the revised proposal will tackle the structural problems that have led to the risk of shortages and disappearance of critical devices from the EU market, supporting availability of these products across the EU for all patients.
It will ensure that Member State are aware of potential shortages on their market at an early stage and that information is provided to other Member States
For patients, healthcare professionals and health systems the revision will contribute to safeguard the availability of safe devices on the EU market and facilitate the development of innovative devices to secure a high level of patient safety and care throughout the EU.
The simplification will increase patient safety as operators will have more resources to address any safety-related concerns that arise.
The reform will also make sure that there is an adequate level of transparency for these products through the first EU comprehensive database for medical devices (EUDAMED), which ensures clear traceability across the EU and supports faster detection and response to safety issues for all medical devices.

How are the proposed changes expected to promote innovation and the competitiveness of the EU medical device sector?

One of the key goals of the targeted simplification is to further enhance the EU’s competitiveness, make business easier and support research and innovation in medical technology by:

Minimising compliance costs: through streamlined procedures and reduced burden on manufacturers, distributors and notified bodies.
Ensuring greater certainty and predictability: by providing companies and notified bodies with clearer timelines so that they can plan their research and development activities better.
Creating more flexibility for changing market conditions: with more streamlined processes for certification and for control to respond more quickly to changing market conditions and customer needs.
Support for top-notch innovations: the introduction of adaptive pathways for breakthrough innovation and orphan or ‘niche’ devices will increase the attractiveness of the EU regulatory system.
Regulatory sandboxes: providing the possibility for innovative companies to conduct live tests of new products in a controlled environment with regulatory oversight but without immediately facing all the usual regulatory compliance requirements.
Increased digitalisation: digitalising procedures to create a more flexible system for the exchange and transmission of conformity assessment related documents, and the provision of electronic instructions for use.
Creating one regulatory framework for medical devices, that are powered by AI, to erase unnecessary duplications and overlaps.

How are the proposed changes expected to impact the coordination and cooperation between national authorities, the Commission, and the EMA?

By strengthening expertise available at EU level, the revision will assist in implementation across the EU and ensure more consistent, science-based regulatory outcomes across Member States.

A central aim of the proposal is to avoid duplication of efforts. This includes closer and more structured cooperation between national authorities and the Commission, particularly in areas such as market surveillance, vigilance assessments, and decision-making on borderline and classification issues.
Enhanced information exchange mechanisms and more coordinated procedures will support more timely, aligned, and transparent regulatory actions.
The reform will also strengthen the European Medicine Agency’s existing role in facilitating coordination for the medical devices sector, drawing on the specific expertise of medical device expert panels.

Source: EU Commission