MHRA Guidance on Clinical Investigations for Medical Devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an updated guidance for notifying clinical investigations involving medical devices. This comprehensive guide provides essential information for manufacturers on the regulatory process, including requirements for submissions, timelines, and necessary documentation. The goal is to ensure compliance with UK regulations while facilitating the safe and effective development of medical devices. Key updates include detailed steps for submitting notifications, an overview of the assessment process, and links to relevant forms and resources. This new guidance aims to streamline the notification process and enhance the clarity of regulatory expectations for clinical investigations. 

For more information, visit the MHRA guidance page. 

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