{"id":18565,"date":"2024-06-04T13:41:27","date_gmt":"2024-06-04T12:41:27","guid":{"rendered":"https:\/\/www.bdk.uk.com\/?p=18565"},"modified":"2024-06-04T13:41:27","modified_gmt":"2024-06-04T12:41:27","slug":"what-new-medical-device-regulations-are-being-released-in-2024","status":"publish","type":"post","link":"https:\/\/www.bdk.uk.com\/2024\/06\/what-new-medical-device-regulations-are-being-released-in-2024\/","title":{"rendered":"What New Medical Device Regulations Are Being Released in 2024?"},"content":{"rendered":"

At the start of the year, there were proposed changes to medical device regulations for 2024 and beyond.<\/p>\n

Laura Squire<\/a>, Med Tech Regulatory Reform Lead and Chief Officer Healthcare, Quality and Access states that, \u201cThe aim of this work is to create a framework which is responsive to the needs of new technologies, strengthens patient safety and provides the certainty and clarity that manufacturers need to bring their products to the UK market.\u201d<\/p>\n

Medical device manufacturers<\/a>, like BDK, recognise and understand the importance of keeping up to date with the regulations for medical devices for our customers. Let\u2019s explore these proposed changes to medical device regulations 2024 and what it means for you and the healthcare industry<\/a>.<\/p>\n

Future Regulatory for Medical Devices Roadmap<\/h2>\n

On 9 January 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) published its\u00a0Roadmap<\/a>.<\/strong> Although there is currently a regulatory framework for medical devices in the UK<\/a>, these proposed changes will update them. Over time, these changes will be delivered through 4 statutory instruments, with post-market surveillance being first priority in 2024.<\/p>\n

Post-Market Surveillance<\/h3>\n

The current existing requirements for manufacturers\u2019 post-market surveillance system are laid out in guidance. The proposed changes for medical device regulations 2024 will set these requirements out more clearly and make it mandatory for the manufacturer to summarise and report their post-market findings to the MHRA.<\/p>\n

This includes clearly defining terms such as \u2018serious incident\u2019, \u2018serious deterioration\u2019 and \u2018serious public health threat\u2019 in line with the EU regulations. In doing so, patient safety will be significantly improved as both the manufacturer and the MHRA will identify issues and take appropriate action much more efficiently.<\/p>\n

Future Core Regulations<\/h3>\n

Future core elements of the new framework are expected to be put into place in 2025. Although they will still focus on patient safety like the improvements to the post-market surveillance system, they will also encourage greater international collaboration and practices. Additionally, there will be more proportionate requirements for medical devices<\/a> which are responsive to advances in technology we will undoubtedly experience.<\/p>\n

Some of these future core regulations include:<\/p>\n