In our September MedTech regulations blog, MHRA Head of Diagnostics and General Medical Devices Joseph Burt seeks stakeholder feedback to two surveys and looks ahead to Autumn updates about the Pre-market statutory instrument, an IVD roadmap and the next IMDRF forum.
Hello again. If you’re anything like me, you’ve probably wondered how the past few months have vanished so quickly! Here at the MHRA, we’ve been busy moving forward on a host of exciting initiatives, and I’m genuinely thrilled to share some highlights with you in this blog. Whether they’re just getting underway or nearing completion, each one is helping to advance safety, access, and innovation in MedTech across the UK—and I couldn’t be prouder of what we’re achieving together.
One of the initiatives is the Health Institution Exemption (HIE) guidance refinements. Many NHS organisations are already using this exemption for medical devices. I want to personally thank everyone who has shared their experiences in Teams meetings and during our visits—your input will help shape our upcoming guidance.
We’ve seen a wide variety of ways the exemption is used, which has broadened our understanding and inspired colleagues with examples of strong governance, patient safety, and high-quality standards for in-house devices. We are now gathering more evidence on how the exemption works in practice. To do this, we published a call for evidence survey to find out how organisations are using the exemption, and there’s still time to give us more feedback before the survey closes on 15 September. All responses will be analysed to help us refine the guidance.
We aim to publish the updated guidance later this year. There is still more we can do, especially in training and education related to parts of the Medical Devices Regulations 2002 that connect with HIE, such as rules for custom-made devices and post-market regulations.
We will also be creating training materials about certain parts of the new pre-market statutory instrument. The draft version of this new statutory instrument is now in its final round of internal reviews. We are preparing a version for World Trade Organization (WTO) notification and, once ready, we will publish the complete legal text of the statutory instrument. This new legislation is an important step to make sure devices are safe before they reach the market. It also encourages innovation and increases access to certain devices with approval from comparable regulators thanks to international reliance routes. We will conduct further engagement on the impact of the statutory instrument through a business survey. Keep an eye out for an upcoming announcement about the WTO notification.
In the broader pre-market requirements, we also need to identify which standards are most important to designate. Designated standards are those officially recognised by UK regulators, including the MHRA, as meeting certain essential safety and performance requirements for devices. These standards are published in an official list.
When a device meets a designated standard, it is presumed to comply with the relevant regulation. The last update to this list was in 2021, and now we want to update it to make sure it’s up to date and useful. We’re asking for your feedback: please let us know which standards your organisation relies on most and tell us if any standards on the list are missing, outdated, or need to be removed or replaced.
We’ll use your responses from our survey to help make these decisions. After gathering input, we’ll publish the updated list so you can easily check which standards may be helpful to use. Moving forward, we’ll put a process in place to keep the list regularly updated when standards change or new ones are added.
I’m excited to share that the in vitro diagnostics (IVD) team has been working on an updated IVD roadmap. We originally planned to publish this in July 2024, but external factors delayed its release. This pause gave us the chance to update and improve the roadmap, bringing together the latest and most innovative work in IVDs across the UK.
IVDs are essential in modern healthcare. They help with diagnosing diseases and monitoring treatments and they will be essential in delivering the government’s 10 Year Health Plan ambitions. The new roadmap will outline our next steps for regulating these devices, taking into account new technologies, the need for strong data integrity, and the ability to respond quickly to emerging health challenges.
This updated roadmap will be an important resource for everyone in the IVD sector. I’m looking forward to hearing your thoughts once it’s published.
Also this Autumn, the MHRA is taking part in the 28th International Medical Device Regulators Forum (IMDRF), which takes place in Sapporo, Japan. Rob Reid will lead the UK delegation and host a session with a panel discussion on Real World Evidence.
Real World Evidence refers to clinical data about how medical devices are used, and their benefits and risks, based on information from real-world sources such as electronic health records, registries, and data provided by patients. This type of evidence is valuable for several reasons: monitoring devices after they reach the market, improving device traceability, conducting evaluations, and understanding how devices are used in everyday healthcare. Through the IMDRF, the UK has an opportunity to help harmonise how real-world data is collected and used around the world, making it easier to share knowledge and best practices internationally.
As medical technology continues to advance, your opinions are important to help shape the future. Please continue to get involved in surveys and feedback opportunities to help the MHRA create a regulatory framework that balances safety with innovation.
By staying engaged and informed, you can help build a future where new medical technologies are both safe and easily accessible, leading to better outcomes for everyone. To stay connected, follow the MHRA on social media, especially LinkedIn, where we share regular updates. Whenever possible, please join us at meetings and events where my colleagues and I share more about the progress of these important initiatives.
I’m excited about the work we’re doing and always welcome the chance for a discussion. So if you see me at an event, please come and say hi. I look forward to meeting you and hearing your perspectives on how we can continue to improve MedTech regulation together.