Guidance document Archives

Guidance document, Swissmedic

Swissmedic, changes to various guidance documents

Information on changes to the following guidance documents are provided below: Changes to the Guidance document Time limits for authorisation applications The international Project Orbis and Access Consortium procedures have been added to the updated Guidance document Time limits for…

1 June 2024

European Union, Guidance document, Medical Device Coordination Group

MDCG publishes Q & A on the MDR regarding clinical investigation

The Medical Device Coordination Group (MDCG) has published a Q & A on the Medical Devices Regulation (EU) 2017/745/ (MDR) regarding clinical investigation. The document MDCG 2021-6 is entitled ‘Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation’. Who…

28 April 2021