Joseph Burt, Head of Diagnostics and General Medical Devices at the MHRA, speaking at a recent industry forum in Manchester.
I hope you are enjoying the lovely early summer sunshine we’re experiencing across the UK and taking a break to enjoy it. I took some time over the Easter period to take a short break as well. Easter seems like long ago and I hope you were able to enjoy some time with family, friends and loved ones. The break gave me an opportunity to rest and time to reflect on the opportunities to speak with many of you. When I mean you, I really mean you reading this blog now - my colleagues and our partners and in other regulatory organisations, approved bodies, academia, innovators, manufacturers, developers, clinicians, patients and the general public. Thank you so much for your continued support and trust with the work of the MHRA in medical devices and particularly on the MedTech Regulatory Reform programme.
16 June 2025. Do you remember the importance of this date? I may sound like a parrot repeating this date over and over again but it’s a very important date. The Post Market Surveillance regulations come into force on this date, and I want to use this opportunity to remind you to be prepared with the upcoming regulations. The regulations are a significant introduction of Post-Market Surveillance (PMS) and Vigilance requirements into UK regulations. It’s such an important piece of regulation that enhances patient safety and ensures that medical devices maintain high standards throughout their use. These regulations support this government’s priority for improving patient safety.
Vigilance is well understood by many manufacturers and is a pivotal part in medical devices lifecycle management. But more than this, post-market surveillance involves the ongoing proactive monitoring of devices after they have been released into the market to ensure continued compliance with safety and performance requirements. This continuous monitoring helps detect potential adverse effects, identify opportunities for improvement and maintain public trust in medical devices and IVD devices. These regulations enable the MHRA to look at pragmatic and flexible pre-market approaches such as reliance and early access, which in turn supports innovation and growth.
I want to highlight a few important points about the PMS regulations. There are enhanced reporting requirements where manufacturers will be required to submit detailed and timely reports on the performance and safety of their devices. The regulations will require a proactive approach to risk management where manufacturers must identify and mitigate potential risks during the product's lifecycle, ensuring swift action to address any emerging issues. The MHRA will require greater transparency in reporting and communication and manufacturers will need to provide information to healthcare professionals and the public. All manufacturers will be required to implement robust surveillance systems capable of capturing a wide range of data related to product performance and safety. It also encourages closer collaboration between manufacturers, healthcare professionals and users. This partnership aims to improve the collection and analysis of real-world data, ultimately enhancing the quality of post-market surveillance. Healthcare professionals and users’ cooperation in reporting safety concerns and providing feedback on product performance will be essential in maintaining the high standards. Moreover, it will encourage innovation and continuous improvement of existing products and has the potential for driving growth.
I understand the difficulties of translating legal text into practice. Therefore, earlier this year, we published guidance to support the implementation and adoption of the PMS regulations. The guidance has been created with you in mind, and I must sincerely thank everyone that has contributed to drafting, refining and making the guidance clear and pragmatic. Your feedback on the guidance has been so helpful and we will continue to update it as part of ongoing improvements to support all who refer to them. The Manufacturers Online Reporting Environment (MORE) has been updated as well with guidance to support manufacturers implementing these changes published last week. Refreshed guidance for the submission of incident reports and field safety corrective actions will be provided in due course. Please take a few minutes to read the new MORE guidance and I hope you find them useful. Tell us if you have ideas for any improvements as well – that’s always welcomed. These regulations usher in an era of sharper focus on active surveillance and vigilance, ensuring that patient safety remains at the forefront of healthcare innovation and access. and access.
I’m also really excited about the progress being made on the MedTech Regulatory Reform programme. The guidance working groups are well underway. As one working group concludes and the second working group currently in full swing, the third working group is ramping up around implantable devices, equivalence and international reliance. I really appreciate the feedback and inputs to our draft guidance documents, and I hope you will find them helpful once published. Earlier in May, Parliament agreed the adoption to remove the sunset date of 25 and 26 May for 4 pieces of assimilated EU law and so these 4 pieces will continue. Take a few minutes to read more about the continuation of the 4 pieces of assimilated EU law.
In addition to preparing the new regulations, a small MHRA delegation visited the Guy’s and St Thomas’ NHS Foundation Trust in central London to meet with the amazing clinical engineering and medical physics teams working on medical devices deployed within the Trust. These innovations were terrific to see in how they are important in patient treatments, but it also gave us the opportunity to observe and learn about devices that are made available to patients of the Trust. I can’t wait to visit Trusts and Boards in Scotland and Wales to see what is done by their teams to provide innovative devices for the benefit of their patients too. We are interested in devices that are provided by many organisations in healthcare and to inform the future policy around in house manufactured devices.
I started this blog with time to reflect on the progress to date. I now want to share my hope and vision for the coming months. The pre-market statutory instrument (SI) will come into sharper focus over the coming months, and I’ll be really thrilled when we’re able to publish the draft legal text. A business survey will accompany the publication to understand what the provisions in the pre-market SI will mean for you. I’m also looking forward to the publications around the IVD roadmap, the refined policy and guidance on in house manufactured devices for medical devices and IVD devices and policy intent for early access and innovation. There’s so much more beyond regulations, like supporting MedTech sector growth initiatives across the UK, preparing for future regulatory science through research in the CERSIs and supporting innovators to launch their technologies for use with patients. I could write more about the other exciting initiatives on the go in this blog but that will have to wait for another blog coming soon – please look out for that. For now, remember 16 June 2025 and be prepared for the PMS regulations.