Yesterdays newsletter from the Association of British Healthcare Industries gave an Overview of Coming Changes under Directive 2007/47/EC as follows:
Modifications have been made to a number of the articles and relevant annexes. These concern clinical data and its evaluation and there are a number of references to clinical data in the provisions of the Directive; this includes the definition of clinical data and there is provision for data to be included in the European databank.
A key change is that manufacturers will have to justify the lack of clinical data if none is available and they will also have to justify why a clinical investigation has not been undertaken for high risk devices. If a manufacturer chooses to follow the literature route, he must be able to provide evidence of equivalence between his device and that covered in the cited literature. Finally, where post-market clinical follow up on a device is not judged to be needed, this needs to be justified.
Another major change concerns the definition of stand-alone software. The new definition states that software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes is now regarded as a medical device in its own right.
MHRA has identified a number of examples of the types of devices which will fall into this category:
- The NHS software algorithm to screen for swine flu infection
- Software providing a cognitive training/stimulation programme for patients with specific conditions or impairments in order to cause improvements
- A system which detects specific changes in patients using an algorithm acting on data from a number of inputs (e.g. movements, voice analysis etc) in order to propose clinical interventions, medication, hospital referrals etc.
- Software facilitating remote, large-scale, on-line patient screening, for example to identify ophthalmic conditions diagnosed by qualified hospital ophthalmologists
- Software that carries out complex analysis/trending of measured physiological parameters which the clinician relies upon when making a diagnosis