Hello, and welcome to Talking digital health, a podcast by law firm Mills & Reeve, hosted by health and tech lawyers, Sophie Burton-Jones and Charlotte Lewis.
Our aim on this podcast is to discuss key topics of interest to those procuring tech in the NHS and also those selling tech to the NHS.
I'm Sophie Burton-Jones, a partner in the technology team at Mills & Reeve and your host for this episode. I'm delighted to be joined by Stephanie Caird, a partner in the Mills & Reeve life sciences team who specialises in medtech.
Hi, Sophie. Thank you so much for having me today.
Thank you for joining us.
In this episode of Talking digital health, we'll be talking about medical device regulation and what you should be thinking about and when if you're developing a new healthtech product for the NHS market.
So, first of all, how soon do you think developers of healthtech should speak to somebody who's got legal or regulatory background about what they're planning to do in this space?
In typical lawyer fashion, I'd probably say the sooner the better. But generally, I would say when it becomes clear what your intended application or use of the product is. And the reason I say that is because if you're intending to use your tech for a medical purpose, like managing a disease or diagnosis, or you want your tech to be used with an existing medical device, for example, if it's going to be reading out blood values and then analysing that data, you might find themselves straying into regulated territory fairly quickly and therefore it's worth having those conversations early so that you don't get taken a back or off guard when it transpires that you do fall within the medical device regulations. And so, it's fair to say it doesn't only affect the marketing of the final product then.
Yeah, that's right. So, if you're planning to do a clinical investigation with people, ie using patients to try out your device, then you might have to engage with the regulator already, which in the UK is the Medicines and Healthcare Products Regulatory Agency.
And the reason you might have to engage with them is, for example, you have brand new technology and you don't know what it works like at all in clinic, or you have an existing device that is already CE marked or UK CA marked and you want to see if it could be used for something else. So, if you're planning on doing those kind of investigations with people, you will need to notify the MHRA 60 days in advance of undertaking the investigation. And that is to allow them time to assess what you're planning to do, whether you've got the right research ethics approvals in place. etc. So planning that into your pipeline development timelines is really important.
Okay, great. So, once you've gone and done those clinical investigations and got the data, can you then just go ahead and market the product?
It'd be nice if it were that simple, really. But there are generally requirements around you needing to apply a UKCA or CE marking to your product and being registered with the MHRA, both in terms of the product and as a manufacturer before the devices are placed on the market.
Now, depending on what classification your device has, you might be able to self-certify and apply the marking yourself. The riskier the product is, or the more invasive the technology is, you'll need to get a notified body involved to do an assessment of your documentation. If you need to involve a notified body, you'll need to factor that in both from a time and money perspective, because they sometimes have backlog in reviewing paperwork and at one point the backlog was about six to eight months long and you won't be able to submit your registration paperwork to the MHRA until you have that assessment.
Great. And for those of us not up on all the terminology, who's a notified body in this context?
That is a good question actually. So, for medical devices, there are a number of different notified bodies available. Common ones would, for example, be BSI. Internationally, you also have TÜV Rheinland or TÜV SÜD as big, notified bodies. But these are all separate from the regulator, with the idea being that they can provide an independent assessment of the information provided by the manufacturers. But yeah, there's a wide range available. And the MHRA or government keeps a list of UK approved bodies available on its website.
Excellent, thank you.
And so, once you've gone through and you've got all that in place, can you then as a developer go ahead and market your product, or is there more that you still need to do?
So, you can then market your product, but I would mention that there are some potential pitfalls to be aware of when you're making any medical claims about products, and that is whether or not they are medical device. And the reason for that is that there are some restrictions on what claims you can make of a medical nature in relation to products in your advertising. And the Advertising Standards Agency, in light of a flood of the market of information for women's health products, particularly in connection with menopause, has become a lot stricter on enforcement of marketing claims of a medical nature. So if you are going to be marketing your products, just make sure that what claims you make don't fall foul of advertising standards rules.
So another kind of complex or mine-filled area that somebody might need some help navigating through, any top tips?
Yeah, well, it is a fairly complex area, but from my experience, it's all it's all a process. So, if you're following the process, it's actually fairly manageable, and being prepared for following that process is the best thing that you can do. So please don't stick your head in the sand and pretend it's not happening.
I would say speak to a trusted advisor about what your product does and where you want to get to and then work from that backwards, then it's just a case of seeing whether you do it all in one go or whether you might want to do it in stages. So, you could, for example, for software, do a first release that is not a medical device and then start generating income and apply that for a second release that is a medical device but use the money for the regulatory process.
We're, of course, always happy to help have those discussions with you and help you navigate through the regulatory process and the advertising process. And we do also have regulatory consultants who can help you with the paperwork with the MHRA.
Thanks, Stephanie.
I mean, as you say, Mills & Reeve are very happy to discuss any legal queries you might have about healthtech, including on medical device regulation.
If you would like any more detail or to talk about anything with us, then our individual contact details are available on our website at mills-reeve.com.
Thank you for joining us on this episode of Talking digital health by law firm Mills & Reeve.