MDCG 2021-08 Guidance on Clinical Investigation Application and Notification

Regulatory News

The Medical Device Coordination Group (MDCG) has endorsed a document on the topic of clinical investigation application/notification since EUDAMED module for clinical investigations is not yet functional. The sponsor of a clinical investigation is required to submit an application / notification to the Member State(s) in which a clinical investigation is to be conducted, accompanied…

New UDI Requirements in Singapore

Regulatory News

Singapore’s Health Science Authority (HSA) has announced that they will follow many countries example and begin implementing a Unique Device Identifier (UDI) system. UDI is an international system for identifying Medical Devices (MDs) meant to help quickly identify people affected by product recalls, device failures, or serious adverse events. UDI has been adopted by the…