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EMA Med.Dev Guidance: Guide to Requesting Advice from Expert Panels for Orphan Medical Devices
The guidance Guide to manufacturers and notified bodies on the procedure for requesting advice from expert panels for orphan medical devices was published on 31 March 2026 , outlining the procedural framework and expectations for applicants seeking scientific and regulatory advice. Orphan medical devices are those intended for the diagnosis, prevention, or treatment of rare conditions, where limited patient populations create challenges in generating extensive clinical evi
Sharan Murugan
17 hours ago3 min read
EC MDCG: Guidance on Clinical Evaluation of Orphan Medical Devices
The European Commission Medical Device Coordination Group (MDCG) has issued a new guidance "Clinical Evaluation of Orphan Medical...
Sharan Murugan
Jun 29, 20242 min read