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 rely on this guidance to help you meet the regulation. The UK MHRA webpage includes the text of their guidance for how to apply the requirements of 207/2012 on electronic labeling of medical devices.
Past posts to refer to includes:
- Electronic IFUs for EU MDD & AIMDD Devices
- EC publishes draft regulation on electronic IFUs of Medical Devices
UK MHRA Guidance on EU Regulation 207/2012 on electronic labeling of med dvcs