New standard procedure advice for high-risk medical devices

The European Medicines Agency (EMA), in collaboration with the European Commission, has announced the implementation of a new standard procedure for scientific advice for manufacturers of high-risk medical devices.

The measure aims to strengthen the safety and efficacy of these products, ensuring more robust clinical development and accelerating their access to the market.

Specialized Support for High-Risk Devices

Manufacturers of class III devices and active class IIb devices that administer or remove drugs can now submit requests for advice through a digital portal.

During the process, they will have access to panels of experts who will assist them at various stages of clinical development, providing valuable insights into research methodologies and regulatory compliance.

Benefits of the New Procedure

Improved safety and efficacy: Expert advice will help mitigate risks and improve the quality of devices prior to marketing.
Accelerated innovation: Manufacturers will be able to adjust their research strategies according to expert recommendations, reducing regulatory barriers.
Positive impact on public health: Patients will have faster access to innovative and safe devices.

Continuation of previous initiatives

The procedure builds on a pilot project started in February 2023, which received positive feedback from both the manufacturers and the experts involved. The EMA plans to publish a detailed report on the results of this pilot in the coming weeks.

In addition, medical devices targeting rare diseases should follow a specific pilot program for orphan devices, ensuring differentiated support for this critical segment.

An Important Step for Health in Europe

With this initiative, the EMA reinforces its commitment to medical innovation and the protection of European citizens’ health, promoting a more agile and secure regulatory environment for the development of advanced medical technologies.

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