The European Medicines Agency (EMA), in collaboration with the European Commission (EC), has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice on their planned clinical development strategy and proposals for clinical investigation.
Under the new initiative, manufacturers of Class III devices and Class IIb active medical devices intended to administer or remove medicines can now submit scientific advice requests via a portal and consult with medical device expert panels at different stages of the clinical development of their device.
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The initiative follows a pilot that was launched by the EMA in February 2023. To help establish the initiative’s relevant processes, the year-long pilot involved expert panels providing free advice to 10 applicants on their clinical development strategy and proposals surrounding their clinical investigation.
The EMA plans to publish a report on the pilot in the coming weeks.
The agency said its overall hope for the advisory portal is that it can foster innovation among medical device manufacturers and promote faster patient access to safer and more effective devices.
The EMA is currently inviting manufacturers of high-risk medical devices and Notified Bodies to apply for its pilot programme to support orphan medical devices. The pilot programme is for the provision of free advice on a possible orphan device status and on the clinical evaluation of orphan medical devices.
Running until the end of 2025, the EMA stated that the pilot will help new orphan medical devices and legacy medical devices, which are transitioning under rules outlined in the European’s Union’s Medical Device Regulation (EU MDR).
