The answer seems to be in the direction of a US FDA Style review process for some higher class devices (Class IIb & III) which means longer time to market and more hurdles to get past for these types of
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On 9 Jan 2013 the UK MHRA (The Medicines and Healthcare products Regulatory Agency) released a Guidance on EU Commission Regulation 207/2012 on electronic labeling of medical devices. This regualtion came into force on 1 March 2013 so you can
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