The Medicines and Healthcare products Regulatory Agency (MHRA) has published detailed guidance "Clinical Investigations" on notifying and conducting clinical investigations for medical devices in the UK. This guidance outlines the regulatory requirements, submission process, and expectations for clinical investigations involving medical devices and about the information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Below is a comprehensive summary of the key sections and subsections.
A clinical investigation involves the systematic assessment of a medical device on human subjects to evaluate its safety, performance, and intended purpose. These investigations are crucial for generating clinical evidence required for regulatory approvals and CE marking. You must notify the MHRA about your clinical investigation if:
Your study involves a medical device intended for CE marking.
Your device does not yet conform to the requirements of the UK Medical Devices Regulations 2002 (as amended).
To notify the MHRA, you must provide detailed information about the investigation, the device, and its intended use.
Download the Notification Form: The clinical investigation application form is available on the MHRA website.
Compile Supporting Documents: This includes the clinical investigation plan (CIP), investigator brochure, risk assessment, and informed consent documents.
Submit via Email: Send your completed form and supporting documents to the MHRA via the designated email address.
A fee is applicable for each submission, and the amount varies based on the type of device and investigation complexity. Payment details and timelines are provided on the MHRA website.
The MHRA reviews clinical investigation submissions within the following timeframes:
30 days: Standard timeline for review of submitted applications.
Notification of Decision: MHRA may request additional information during this period or approve/deny the application.
Sponsors and investigators are responsible for ensuring compliance with the applicable regulations during the conduct of clinical investigations. Key responsibilities include:
Device Accountability: Tracking the use of devices during the trial.
Monitoring and Reporting: Ensuring safety and efficacy data are monitored throughout the study.
Adverse Event Reporting: Reporting serious adverse events to the MHRA as per the guidelines.
If you need to make changes to the investigation (e.g., design or protocol), you must notify the MHRA. Major changes require prior approval, while minor changes may only need notification. After the investigation, sponsors must submit:
Final Clinical Investigation Report: Summarizing the outcomes, safety findings, and performance data.
Adverse Event Reports: Detailing any adverse events that occurred during the trial.
By following this guidance, sponsors and investigators can align with regulatory expectations, paving the way for CE marking and patient access to innovative medical technologies.
For further details, refer to the full guidance on the MHRA website.
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