How to Navigate the UK's Medtech Sector - Key Developments to Watch
As the UK medtech strategy acknowledges multiple times, the sector is complex. Here are a few key developments to be aware of.
The UK's Medical Device Reforms
The main EU reforms happened just after the Brexit transition period, and Great Britain now has an important job in undertaking its own reforms, the major changes of which are expected to start in July 2025. See the Government's response to the related consultation for more information.
The Innovative Device Access Pathway (IDAP)
IDAP is a UK-wide initiative to help with the uptake of medical technology in the NHS. The MHRA and the UK health technology assessment bodies will run and assess a pilot in 2023. IDAP is specifically referred to in the strategy and described as an end-to-end pathway.
MHRA-HRA Combined Reviews
The MHRA and HRA have recently announced that businesses seeking MHRA approval and a Research Ethics Committee opinion can benefit from streamlined coordinated assessment. This applies to those conducting a clinical investigation of a medical device, although note that some studies are not eligible.
Health Data Protection
The UK's Data Protection and Digital Information (No 2) Bill is passing through the legislative process. In the EU, the Data Act will soon finish the EU legislative process (although it will not apply for almost two years), and the law setting up the European Health Data Space is also going through the motions. Research-use of health data is sure to remain a hot topic for many years to come, particularly as the benefits of combining big datasets are being realised. This is an important area for medtech businesses to understand: innovation is expected to be data-driven, and devices are often points in a complex flow of sensitive health data.
Notified Bodies
Notified bodies (EU) and approved bodies (UK) are in short supply. The EU Medical Devices Coordination Group (MDCG) published a position paper on the issues in late 2022, and, in the UK, there are still only four approved bodies.
The deadlines for various changes brought about by the transition to the new EU medical devices regulations, made additionally complex in the UK due to Brexit, seem to frequently change to give the industry a bit more time to catch up. Know these dates, but prepare early for the changes. If you haven't already, appoint a notified body and an approved body, and plan any required assessment long in advance.
Not Medical Doesn't Mean Not Regulated
Traditionally, we think of regulated medical devices as those that have a medical purpose. This limitation in scope avoids the regulations being cast too wide, but it has been relaxed recently. Is your product within the listed types that are covered by Annex XVI of the Medical Devices Regulation (745/2017)despite having no medical purpose?
What's in a Medical Device?
There has been recent focus on the materials used in medical devices. In particular, check the relevant regulatory guidance relating to:
The UK medical device reforms are expected to include certain sustainability concepts, so now is a good time to assess the greenness of your product throughout its entire lifecycle.
Be Vigilant
In both the UK and EU, regulators have published guidance on post-market vigilance efforts expected of device manufacturers. Ensure your vigilance system is designed with the most recent guidance in mind. As a general recommendation, do not do anything until you have read the report and later update of the IMMDS review and the Government's response.
Many product liability claims in the UK relate to defective medical devices. Therefore, preventing safety issues means preventing claims and should be a high-priority item in your strategy.
Measures Designed to Mitigate Shortages
If your device becomes standard issue for healthcare, particularly critical care, then it may become subject to state shortage prevention measures. In the EU, the EMA has a role in preventing shortages, and the Medical Devices Shortages Steering Group has been established to provide guidance on the topic. Post-COVID-19, governments are keen to secure robust supply chains for critical medical devices during public health emergencies.
Harmonisation
Post-Brexit, the UK Government has an important task in positioning the UK in the global medtech sector (remember that the Government is aiming to be a science and technology superpower). In other international arrangements, nations agree on mutual recognition, creating speedy routes to market based on the regulatory status of products in other territories. The Government has indicated that it might consider recognising the regulatory approvals of trusted foreign jurisdictions like the US. Watch these developments carefully as they might influence your launch strategy.
Is Your Medical Device Actually Something Else?
The borderlines between product types, and the regulation that applies as a consequence of borderline determinations, continue to give medtech businesses grief and lawyers work to do. A recent case in Germany involved the German courts and the European Courts of Justice assessing whether nasal drops marketed as medical devices were instead medicinal products due to the way in which they were presented.
When you embark on your business journey, get an opinion, ideally multiple opinions, or even advice from the regulator itself, on what exactly your product is in legal terms. And get the opinion updated if your product changes. Finding out about an alternative assessment of your product at a late stage of your commercialisation plans is going to cause delays, great expense and potential legal problems.
AI and Software as a Medical Device
Using AI or machine learning in some part of your business is likely to become the norm. You might be incorporating AI technology into your medical device or developing some stand-alone software that is designed to fulfil some medical purpose. Soon, clinicians will rely to some degree on the output of an algorithm, and regulators are publishing detailed guidance on the area in which AI and regulated medical devices meet. If you are developing stand-alone software, then the first place to go is the new MHRA suite (Software and Artificial Intelligence (AI) as a Medical Device). Also, check the NHS's new guidance on AI and digital regulations, and watch out for separate AI regulation that is due to apply in the EU and is being discussed fervently in the UK.
For more information on the strategy, see The UK's New Medtech Strategy, Explained. Are you navigating the medtech space? Have a chat with Harry Hamilton Jennings, in our Pharmaceuticals and Life Sciences team on 07789 533 122, or complete the form below.