Clinical Investigations for Medical Devices in the UK

1. Notification Requirements and Legal Framework In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) must be notified by manufacturers or sponsors intending to conduct a clinical investigation of a medical device. This is a statutory requirement under the UK Medical Devices Regulations 2002 to ensure the device does not compromise the safety or health of users and patients. Source: Notify MHRA about a clinical investigation for a medical device (GOV.UK)

2. Scope of Investigations A notification is required for devices that are not UKCA or CE marked for the purpose intended in the investigation. If a device already carries a valid mark but is being investigated for a new intended purpose, or if it has been significantly modified, a new notification to the MHRA is mandatory. Source: Notify MHRA about a clinical investigation for a medical device (GOV.UK)

3. The Application and Assessment Process The notification process is managed through the Integrated Research Application System (IRAS). Once a valid application is received, the MHRA conducts a safety assessment.

3.1 Statutory assessment timelines The MHRA has a 60-day period to review the notification. If the MHRA does not raise any grounds for objection within this timeframe, the investigation may begin, provided that a favorable opinion from a Research Ethics Committee (REC) has also been obtained. Source: Notify MHRA about a clinical investigation for a medical device (GOV.UK)

4. Documentation Requirements Applicants must submit a comprehensive technical file, which includes:

The Clinical Investigation Plan (CIP) and Investigator's Brochure (IB).

A detailed risk analysis and evidence of preclinical testing.

Informed consent documents and patient information sheets.

Manufacturing information and confirmation of biological safety where relevant. Source: Notify MHRA about a clinical investigation for a medical device (GOV.UK)

5. Amendments and Reporting Obligations Sponsors are required to maintain continuous communication with the MHRA throughout the duration of the clinical investigation.

5.1 Notification of significant amendments If any significant changes are made to the clinical investigation plan or the device itself during the study, the MHRA must be notified. These amendments are assessed within a 35-day period to ensure patient safety is maintained. Source: Notify MHRA about a clinical investigation for a medical device (GOV.UK)

5.2 Adverse events and end of study notification Sponsors must report all serious adverse events (SAEs) that occur during the study to the MHRA. Furthermore, the MHRA must be notified within 90 days of the end of the investigation (or 15 days if the study is terminated early), and a final report must be submitted within one year of completion. Source: Notify MHRA about a clinical investigation for a medical device (GOV.UK)