Mhra Clinical Investigation Medical Device

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Notify the MHRA about a clinical investigation for a …

https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device

The MHRA is working with the Health Research Authority (HRA) to develop a new coordinated assessment pathway which will streamline the review of clinical investigations involving medical devices. During this phase of testing the MHRA Medical Devices review and the Research Ethics Committee (REC) revie… See more

Medicines, medical devices and blood regulation and …

https://www.gov.uk/topic/medicines-medical-devices-blood/clinical-trials-investigations

MHRA phase I accreditation scheme; Medical devices. Notify the MHRA about a clinical investigation for a medical device; Payments and fees. Make a payment to MHRA; …

Clinical investigations of medical devices – guidance for …

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1097798/Information_for_clinical_investigators_-_May_2021.pdf

All proposed changes to the clinical investigation whether relating to the device, aspects of the clinical investigation plan, investigators or investigating institutions must be …

Clinical investigations of medical devices – compiling a …

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1097797/Guidance_for_mfrs_-_compiling_a_submission_to_MHRA_-_May_2021.pdf

Clinical investigations of medical devices 4/16 Submitting a clinical investigation for MHRA assessment It is important to note that the rules for notifying the MHRA of a …

Guidance on applying human factors to medical devices

https://www.gov.uk/government/publications/guidance-on-applying-human-factors-to-medical-devices

MHRA has published guidance on the importance of applying human factors to medical devices, ... Medical devices clinical investigations during the coronavirus …

Chapter 7: Clinical Investigation / Performance Studies

https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom/chapter-7-clinical-investigation-performance-studies

The MHRA considers that the UK medical devices regulations could be amended to require the MHRA to inspect, at an appropriate level, clinical investigation …

In-house manufacture of medical devices in Great Britain

https://www.gov.uk/government/publications/in-house-manufacture-of-medical-devices/in-house-manufacture-of-medical-devices

You must notify the MHRA before you carry out a clinical investigation of a medical device if you are manufacturing it within your healthcare establishment and are selling it …

Medical devices clinical investigations during the …

https://www.gov.uk/guidance/medical-devices-clinical-investigations-during-the-coronavirus-covid-19-outbreak

Investigators and sponsors should keep us updated on how COVID-19 is impacting their studies. The first priority is the safety of participants of clinical …

Medical devices: guidance for manufacturers on vigilance

https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance

The MHRA is responsible for the UK medical device market. Once a medical device has been placed on the UK market, the manufacturer must submit …

Medical devices regulations: compliance and enforcement

https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process

This guidance includes: contact details to report a non-compliant medical device. information on MHRA’s enforcement duties after receiving a complaint. MHRA’s …

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