At the start of the year, there were proposed changes to medical device regulations for 2024 and beyond.
Laura Squire, Med Tech Regulatory Reform Lead and Chief Officer Healthcare, Quality and Access states that, “The 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.”
Medical device manufacturers, like BDK, recognise and understand the importance of keeping up to date with the regulations for medical devices for our customers. Let’s explore these proposed changes to medical device regulations 2024 and what it means for you and the healthcare industry.
Future Regulatory for Medical Devices Roadmap
On 9 January 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) published its Roadmap. Although there is currently a regulatory framework for medical devices in the UK, 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.
Post-Market Surveillance
The current existing requirements for manufacturers’ 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.
This includes clearly defining terms such as ‘serious incident’, ‘serious deterioration’ and ‘serious public health threat’ 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.
Future Core Regulations
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 which are responsive to advances in technology we will undoubtedly experience.
Some of these future core regulations include:
- Up-classifying implantable medical devices
- Ensuring devices have a unique device identifier (UDI)
- Strengthening the requirements for quality management systems and technical documentation
- New requirements for exempt in-house manufactured devices and custom-made devices
- Aligning essential requirements for medical devices being placed on the market in Great Britain with those of the EU
Medical device regulation is vital to assure patient safety and comfort and adjusting the framework alongside changing technology and other factors is just as important.
We resonate with these proposed changes as one of our main priorities is patient comfort and safety when it comes to medical device manufacturing. We understand as the medical technology evolves, so do our capabilities and services which is why innovation has always been at our core.
With over 60 years’ experience in the healthcare industry, you can rely on us to keep you up to date with medical device regulations for 2024 and beyond. Get in touch with us today to discuss your next project with us.
