Did you know that it’s surprisingly easy to be the manufacturer of a Medical Device without even knowing it?
Yes, it’s true. Why does this matter? Well, in law it’s the manufacturer’s responsibility to CE Mark a product as a Medical Device. And if you haven’t, you might have some difficult questions to answer. So how might this situation come about?
Over-egging the marketing
Even if a digital health product doesn’t functionally fall within the Medical Device Regulation, if you describe it as though it were a Medical Device then, guess what? From a regulatory perspective, it is one. Marketeers love to drive home the life-saving benefits of an app or position the platform as the next revolution in chronic disease management. But be careful – it’s a fine line. A lawyer, court or the MHRA might frame this as a medical claim, which might well bring it in scope of the Regulation and land you in trouble if you’re not CE Marked.
Re-tweeting your customer’s views
Similarly, if you publicly retweet or otherwise endorse something said by a customer or user, this too can be seen to form part of your Intended Use. “My diabetes is finally under control now I’m using this app! #medicalmarvel” – by re-tweeting, you are implicitly validating that the system can be used for diabetes control…and that’s a Medical Device.
White-labelling a Medical Device
Say you take a CE Marked app and rebrand this with your own corporate identifiers. You, not the original supplier, are now the legal manufacturer of the device and take full responsibility for the CE Marking – even though it’s been CE Marked already. Should someone come to harm as a result of using the device, it’s likely that you will be in the dock, not your supplier.
Importing a Medical Device from outside the EU
If you take a Medical Device which is manufactured outside the EU and you bring it to market within the EU then you may become the manufacturer if the original supplier does not have an Authorised Representative (AR). An AR is a person or company who essentially acts on behalf of the supplier in the EU and is responsible for carrying out certain tasks. But, if at any point in time, there isn’t one, then all responsibility for CE Marking may fall to you.
Modifying a Medical Device or changing its Intended Use
If you take another supplier’s Medical Device and modify it in some way, from a regulatory perspective it now becomes your device. Similarly, if you repurpose a Medical Device beyond its Intended Use, then once again, it’s yours. And be careful because you might not even be aware of the original Manufacturer’s Intended Use unless you specifically ask for it. For example, suppose you integrate a CE Marked component into a product which is a patient-facing app but the component was only ever intended to support medical professionals – you’ve changes its Intended Use and you are now its manufacturer.
But even if we were guilty of these sins, how would anyone ever find out – I hear you say? Well, think about it. Is there anyone out there who might have a vested interest in having a quiet word with the MHRA? A competitor perhaps? In practice, it’s how the MHRA finds most manufacturers in breach.
To get an idea of whether a product might be a Medical Device, take a look at our Decision Tree. You simply need access to our free Members Area. But if you’re in any way unsure, then get help. A short conversation to talk through how your product fits into the regulatory framework can save an awful lot of heartache when things go wrong.
Dr Adrian Stavert-Dobson is the Managing Partner of Safehand, independent consultants in DCB 0129/0160 compliance, and the author of Health Information Systems: Managing Clinical Risk.