Clinical investigations of medical devices – guidance for manufacturers
MHRA Revised Guidance – Clinical investigations of medical devices – guidance for manufacturers
Published in Clinical Investigation, Clinical Trial and Medicines and Healthcare Products Regulatory Agency - MHRA
More from Clinical InvestigationMore posts in Clinical Investigation »
- EU – MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
- EU – MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0
- US – FDA issues “Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic”
- BR – Plano de Ação de Pesquisa Clínica no Brasil (in Portuguese)
- FDIS of ISO 14155:2020 (edition 3)
More from Clinical TrialMore posts in Clinical Trial »
- US – FDA issues “Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic”
- BR – Plano de Ação de Pesquisa Clínica no Brasil (in Portuguese)
- FDIS of ISO 14155:2020 (edition 3)
- IMDRF Final Documents – Clinical Evidence, Clinical Evaluation and Clinical Investigation
- Grey literature and medical devices
More from Medicines and Healthcare Products Regulatory Agency - MHRAMore posts in Medicines and Healthcare Products Regulatory Agency - MHRA »
- UK – Independent Medicines and Medical Devices Safety Review report and MHRA response
- UK – MHRA – Effective field safety notices (FSNs): guidance for manufacturers of medical devices
- UK – Medicines and Medical Devices Bill: overarching documents
- UK – MHRA revised guidance – Guidance Notified bodies for medical devices
- MHRA guidance – Assistive technology: definition and safe use
Be First to Comment