We have just found out that the deadline for receiving responses to the NICE review we covered before Christmas has been extended to 6pm on 9th January. As we also understand that there have only been two submission so far to the DH expressing concern that NICE’s remit does not include medical apps (or indeed any wearables or point-of-care-testing devices etc.), can we please urge you to put in a response, even if it is only a few lines? Details are here (ignore the deadline on the website – we have been assured by the DH it is extended by a week). In addition, if you want to see the DHACA submission, it’s here.
We have just discovered that responses for an MHRA review also close at 6pm on 9th January as well, although we are hoping for an extension as happened for NICE (watch this space). Details are here. It looks altogether simpler to complete – again I’m happy to share DHACA’s submission (when completed) if anyone wants to see it (email firstname.lastname@example.org). For the MHRA, specifically for medical apps, the key issues you may wish to raise include:
- the relationship with NICE, particularly for evidence gathering (MHRA requires evidence to prove safety, NICE should require evidence to prove efficacy);
- the shortage of available personnel to police the medical apps market and stop the distribution of software that meets the Medical Device definition and that does not have CE certification.
Personally I also worry that the MHRA staff who work on medical devices are not a single team – they are scattered about the Agency.
These reviews happen only every three years, so if you possibly can, do please submit something for both!