Module 17 2024

05/12/2024

Chapter 8: Post Market Surveillance & Vigilance

f. feedback and complaints from users and economic operators. g. information regarding similar medical devices h. patient and public involvement. The plan must outline how this information is to be collected and assessed. The plan should cover the methods used to collect, process, and assess data, the protocols in place to identify statistically significant increases in certain events, and the methods used to take corrective measures.

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In September 2024 the government announced that draft regulations for post-market surveillance of medical devices are set to be laid before Parliament by the end of this year. These regulations will introduce more robust reporting requirements for manufacturers in the event of incidents, with higher-risk devices subject to additional surveillance measures. The expectation is that these regulations will further improve patient safety by ensuring faster identification and response to safety incidents. It is also anticipated that this framework will bring the UK more closely in line with other international jurisdictions. Chapter 8: Post Market Surveillance & Vigilance

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