The European Medicines Agency (EMA), in collaboration with the European Commission, has introduced a regular procedure for manufacturers of high-risk medical devices to obtain scientific advice on their clinical development strategies. This new framework aims to enhance patient safety, foster innovation, and accelerate access to effective medical devices across Europe.

Key Highlights:
Scope of the Procedure:

• The procedure applies to Class III devices and Class IIb active devices designed to administer or remove medicines.

• Manufacturers can submit requests for advice via a dedicated portal and consult medical device expert panels at different stages of clinical development.

Objective of the Initiative:

• The scientific advice aims to promote faster patient access to safer, more effective devices.

• The procedure encourages early and continuous dialogue between manufacturers and regulatory experts, ensuring compliance with clinical standards.

Background and Pilot Program:

• The regular procedure follows a successful pilot launched in February 2023, which received positive feedback from manufacturers and experts.

• EMA will publish a detailed report on the pilot in the coming weeks.

Fee Structure and Submission Process:

• There are currently no fees associated with submitting requests for scientific advice.

• Detailed submission instructions and monthly deadlines are available on EMA’s website.

Support for Orphan Medical Devices:
Manufacturers of high-risk devices for rare conditions should apply for advice via the ongoing pilot programme supporting orphan medical devices.

Statements from EMA:
“The establishment of this regular scientific advice procedure marks a significant step in promoting innovation in the medical device sector. It ensures manufacturers have the guidance they need to bring safer, more effective devices to patients faster.”The EMA’s new regular procedure for scientific advice is expected to streamline the clinical development of high-risk medical devices, fostering regulatory compliance and innovation. By offering manufacturers early and continuous access to expert guidance, the EMA aims to enhance the safety and effectiveness of medical devices while improving patient outcomes across Europe.