Dive Brief:

• The European Medicines Agency (EMA) said Monday it has established a way for manufacturers of certain high-risk medical devices to request scientific advice.
• Manufacturers of class III devices and class IIb active devices intended to administer or remove medicines can use a portal to request advice on their intended clinical development strategy and proposals for clinical investigation.
• The EMA, which is not currently charging for the advice, said the portal will enable consultations with medical device expert panels that can promote faster access to new technologies. 

Dive Insight:

The EMA established the scientific advice procedure after reviewing the findings of a pilot project. When the EMA began the pilot project in February 2023, the agency intended to provide free scientific advice to 10 companies. The EMA plans to publish a report on the pilot in the coming weeks but has already made the procedure a permanent part of its offering.

The portal is open to manufacturers of class III devices and class IIb active devices intended to administer or remove medicines that have questions about clinical matters. The questions can only cover clinical investigations that are yet to start, the EMA said in its guide to the procedure. 

The EMA has created a form for companies to express interest in receiving advice. After filing the form, companies will provide more information at an exploratory meeting, in a briefing document and through a brief presentation. The expert panel will provide a list of questions for each applicant. The exchanges lead up to the delivery of written advice from the expert panel to the applicant. 

Under the Medical Device Regulation, companies must give “due consideration to the views expressed by the expert panel,” according to the guidance document. The requirement means manufacturers may need to take “additional actions” after receiving advice through the new procedure, the EMA said. 

In the pilot, the EMA prioritized devices for unmet medical needs and novel devices with a possible major clinical or health impact. Going forward, the agency said it will only use those criteria to prioritize requests “should the number of submissions for a given time slot exceed the capacity of the expert panels.” 

The pilot also prioritized devices for use against rare diseases. However, the EMA subsequently started a separate pilot focused on orphan devices for rare diseases. The agency is encouraging manufacturers of orphan devices to consider seeking advice via the rare disease pilot, which it plans to run until the end of 2025.