European Parliament Resolution Urges Immediate Reforms to Medical Device Regulations

The European Parliament’s resolution of 23 October 2024 addresses significant challenges in the current MDR and IVDR frameworks. Although these regulations were implemented to enhance patient safety, transparency, and foster innovation, they have in practice also created bottlenecks, especially for small and medium-sized enterprises (SMEs). The complex and lengthy certification processes have resulted in delays, limiting access to crucial medical devices and diagnostic tools for patients across the EU​​.

In response, the Parliament calls for a systematic revision of the MDR and IVDR, focusing on reducing unnecessary regulatory burdens. Key among these is the recommendation to remove the five-year re-certification requirement for products already under robust post-market surveillance, which, according to the European Parliament, will prevent unnecessary delays in the availability of updated medical technologies​.

The resolution also advocates for the establishment of fast-track pathways for innovative devices, particularly those addressing unmet medical needs or linked to health emergencies. This would ensure timely access to breakthrough medical technologies, thereby improving patient outcomes and supporting public health​​.

Furthermore, the Parliament highlights the need for greater transparency in the fee structures of notified bodies. Ensuring predictable and fair fees will allow SMEs to better navigate the certification process and make informed choices, promoting competitiveness in the European medical device sector​.

The European Commission is expected to present legislative proposals by early 2025 to address these challenges and support the competitiveness of European medical companies while ensuring patient access to life-saving medical innovations.

For further details, read the full European Parliament resolution here