24 March 2025
EMA: Establishment of regular procedure for scientific advice on certain high-risk medical devices
The European Medicines Agency (EMA) has established a standard procedure for manufacturers of certain high-risk medical devices in close collaboration with the European Commission. The standard procedure streamlines requests on scientific advice on the manufacturer’s intended clinical development strategy and proposals for clinical investigations. Manufacturers of class III devices and class IIb active devices for administering or removing medicines can now submit requests via a portal and consult expert panels at various stages of the clinical development. Currently, there are no fees for these requests, and detailed submission guidelines are available on the EMA's website.
For more information, see here.
More News
-
-
Swissmedic: New strategic Approach to minimizing Animal Testing in the Development of Medicinal Products
-
European Medicines Agency: New oral GLP-1 Medicine for Weight Management and Type 2 Diabetes
-
Swissmedic: The new Pharmacopoea Helvetica 13
-
FOPH: Capital Income of Health Insurers for Premium Reduction – current voluntary System deemed sufficient
-
Decision C-6534/2024 of 13 October 2026
-
Swissmedic: Haemovigilance Annual Report 2025
-
Swissmedic: GMP Compliance by foreign Manufacturers - Simplifications for Industry and Clarification of unresolved Issues
-
European Medicines Agency: Clinical Trial Applications Advice Pilot becomes permanent
-
European Medicines Agency: Global regulators call for advancing alternatives to animal testing