Module 17 2024

05/12/2024

Chapter 7: Clinical Investigations

Summary of safety and clinical performance (SSCP) The regulations set out the minimum requirements for what should be included in the SSCP. The manufacturer will have to upload the full SSCP to the MHRA registration system and make it publicly available. SSCPs will be required for the following devices: a. Class III medical devices (excluding investigational medical devices) b. Implantable medical devices (excluding investigational medical devices)

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PMS Plan The regulations strengthen the requirement for manufacturers to implement a post market surveillance system in respect of all medical devices they have placed on the UK market. This will be based on the manufacturer’s post-market surveillance plan, which collates and utilizes information from: a. serious incident data b. field safety corrective actions (FSCAs) c. non-serious incident data, trend reporting d. relevant literature, e.g. scientific studies on the medical device or similar devices e. data from registries Chapter 8: Post Market Surveillance & Vigilance

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