On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the anticipated regulation of medical devices in the UK, should the UK leave the EU without a deal (Guidance). This Guidance will apply from ‘exit day’ (expected to be 11 p.m. 29 March 2019) subject to … Continue Reading
In February 2014, the MHRA published new guidance on borderline medical devices. The guidance considers only medical devices within the terms of the Medical Device Directive and not the Active Implantable Medical Devices Directive or In Vitro Medical Devices Directive. Purpose and mode of action The MHRA makes clear that borderline determinations “will be based on the stated intended purpose of … Continue Reading
