EU: Medical devices and in vitro diagnostics – targeted revision of EU rules

 

The EU Commission is conducting a public consultation regarding a revision of EU rules for medical devices and in vitro diagnostics.

Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic devices (IVDR) were adopted in 2017. Their purpose is to establish a strong, transparent, predictable, and sustainable regulatory framework that safeguards health and safety while encouraging innovation (MDR/IVDR Recital 1), and to bring EU rules in line with international standards.

The MDR has applied since 26 May 2021 and the IVDR since 26 May 2022. However, implementation has been difficult. Stricter requirements applying even to existing devices, limited capacity of notified bodies, and insufficient manufacturer preparedness have created risks of device shortages and market withdrawals. As a result, the transitional periods under the MDR and IVDR have been extended multiple times through Regulations (EU) 2022/112, 2023/607 and 2024/1860, with deadlines now stretching to December 2027, 2028, or 2029 depending on device type and risk class. Since 2024, the Commission has been carrying out a targeted evaluation of the Regulations. In parallel, the European Parliament, many Member States, and numerous stakeholders have called for simplification of the framework.

The revision now under consideration seeks to streamline and modernise the rules by reducing bureaucracy, improving predictability and cost-efficiency, and ensuring sustainability, while maintaining a high level of public health protection. Whereas the targeted evaluation and its Call for Evidence focused on identifying shortcomings, the current Call for Evidence aims to collect input on concrete solutions.

Although all actors share the overarching goals of the MDR and IVDR, stakeholders highlight problems such as unpredictable certification timelines, inconsistent practices across Member States, and requirements seen as disproportionate to the actual risks of certain devices. These factors increase costs and burdens, particularly for SMEs, and may discourage the supply or delay the launch of devices, with negative consequences for patients and public health. They may also undermine the global competitiveness of the EU medical device sector.

Without further EU action, these issues are likely to persist and continue affecting both the market and patient care.

The new initiative therefore aims to simplify and adapt the framework without altering its core structure. Its specific objectives are to:

• reduce administrative and reporting burdens;
• increase the predictability and cost-efficiency of notified body certification processes;
• make conformity assessment requirements more proportionate, especially for low- and medium-risk devices and those serving specific patient needs;
• promote further digitalisation;
• streamline governance and procedural rules;
• strengthen international cooperation, including reliance mechanisms where appropriate;
• improve alignment with other relevant EU legislation.

To find out more about compliance for medical devices in the EU, do not hesitate to contact the Product Compliance Institute.