New rules aim to ensure better protection of public health while reducing administrative burden for manufacturers, especially small and medium-sized enterprises (SMEs).
EU, 16 Dec 2025 — The European Commission has proposed a targeted simplification of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations. The move is designed to address identified shortcomings that have negatively impacted competitiveness, innovation, and patient care in the sector.
Medical devices, ranging from simple plasters to advanced brain implants and diagnostic software, play a critical role in healthcare. The sector is a major employer in Europe, with over 930,000 people employed across 38,000 companies. However, an evaluation of the current legislation revealed inefficiencies, including divergent applications of legal requirements and overly complex procedures.
“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,” the Commission stated.
KEY ACTIONS OF THE REFORM : EU COMMISSION PROPOSES SIMPLIFICATION
The reform aims to modernise the legislative framework through several key actions:
- Reduced administrative burden: Enhanced coordination among regulatory actors and simpler rules for all key players, particularly SMEs.
- Proportionate requirements: Conformity assessment procedures will be made more predictable and balanced, especially for low- and medium-risk devices and those for small patient populations.
- Support for innovation: Introduction of “regulatory sandboxes” to allow testing of new products in a controlled environment and adaptive pathways for breakthrough technologies.
- Increased digitalisation: Extending the possibility of electronic instructions for use (eIFU) and allowing digital labelling to create a more flexible system.
- Maximum timelines: Setting capped timelines for conformity assessment activities to optimize processes for notified bodies.
EU MEDICAL DEVICE REGULATIONS SIMPLIFICATION: BOOSTING INNOVATION AND SUPPORTING SMES
Small and medium-sized enterprises, which make up around 90% of the sector, are a primary focus of the new rules. The Commission plans to reduce entry barriers by streamlining procedures for determining the status and classification of devices. Additionally, the European Medicines Agency (EMA) will provide dedicated advice and guidance to support these companies.
To further boost competitiveness, the simplification is expected to bring about €3-5 billion in cost savings per year. The introduction of a dedicated IT portal will also help manufacturers report supply interruptions, ensuring better monitoring of critical device shortages across Member States.
“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,” the Commission added.