MHRA Updates Guidance on Clinical Investigations for Devices
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31 January 2020
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Posted by: inetika
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Category:
GLOBAL NEWS
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance titled ‘Notify MHRA about a clinical investigation for a medical device‘ for study sponsors on notifying the agency about clinical investigations to support a CE Mark.
The guidance covers the following topics:
- How to notify MHRA of your clinical investigation
- In Vitro Diagnostic Medical Devices (IVDs)
- Special circumstances for healthcare establishments
- Heath Research Authority (HRA) approval
- More information