Why is the Commission proposing a targeted simplification of the Medical Devices Regulations?
Medical Devices and in vitro diagnostic medical devices range from sticking plasters, influenza and pregnancy tests to advanced imaging equipment, implants such as hip replacements, brain implants, pacemakers and, diagnostic software. They play a key role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention and treatment of diseases. With more than 930,000 people employed in over 38,000 companies (of which 90% are small and medium-sized), the EU medical devices sector is a global leader and a major employer in Europe.
The Medical Devices and In vitro Diagnostics Regulations are a set of rules governing the development, production, and distribution of medical devices and in vitro diagnostics within the EU. The rules of those regulations aimed at establishing a modernised and more robust EU legislative framework to ensure better protection of public health and patient safety. However, an evaluation of the legislation identified shortcomings having a negative impact on competitiveness, innovation and patient care. For example, at present, coordination mechanisms are inefficient, there is a divergent application of legal requirements by notified bodies and competent bodies and some procedures are overly complex and costly.
The targeted revision proposed today will simplify the rules for medical devices and in vitro diagnostics to make them easier, faster and more effective – while keeping the highest safety standards for medical device regulation globally. It will make the sector more competitive in the internal market and globally by supporting innovation.
What are the main objectives of the simplification and what is changing from the existing rules?
Key actions of the reform include:
- Reduced administrative burden and enhanced coordination among regulatory actors through more efficient reporting obligations, simpler rules and 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.
As part of the reform, the Commission has launched a set of actions with immediate effect to improve the predictability and efficiency of the certification process for medical devices. Through three acts, the Commission is proposing to:
- Set maximum timelines for the completion of conformity assessment activities to optimise the process for notified bodies and ensure safe and continuous supply of medical devices.
- Support breakthrough medical technologies and their timely certification, and availability.
- Reduce unnecessary regulatory burden for devices based on long-standing, well-understood and established technologies.
What are the main benefits for patients and healthcare professionals?
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.
Most importantly, today’s revision 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. EMA will be monitoring shortages of medical devices and facilitate decisions by national authorities and the Commission on measures to avoid shortages. A dedicated IT portal for manufacturers will be set up to report about interruption or discontinuation of supply and a list of critical devices will be created.
How will small and medium-sized enterprises in the medical device sector benefit from the simplified rules?
There are more than 38,000 medical technology companies in Europe. Of them, small and medium-sized enterprises make up around 90%, the majority of which employ fewer than 50 people. Altogether, the medical technology industry employs more than 930,000 people in Europe. Given their particular importance in this sector, the new rules will give special focus to the needs of these small companies.
Streamlined regulatory procedures for determining the status and classification of devices will reduce entry barriers and provide legal certainty and facilitate market access for smaller operators. To support small and medium-sized companies implementing the rules, dedicated support will be provided by the European Medicines Agency to give advice and guidance on regulatory processes.
How will the revision promote innovation and the competitiveness of the EU medical device sector?
The European market of medical devices is estimated at €170 billion in 2024, being the second largest in the world, according to MedTech Europe. The European medical device sector is a very diverse and innovative sector that has demonstrated steady growth since 2017.
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.
Overall, more efficient and predictable processes will make the relevant EU sectors more attractive to investors, both domestic and foreign, which could lead to increased investment and growth in the sector. At most conservative estimates, the simplification will bring about €3-5 billion in cost-savings per year.
How will the proposed changes affect the coordination and cooperation between national authorities, the Commission, and the EMA?
By making stronger 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.