The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published Guidance on the regulation of medical devices from 1 January 2021 (the “Guidance”). It discusses the regulatory requirements that apply to medical devices after the end of the Brexit transitional period under the EU-UK Withdrawal Agreement. In summary: From 1 January 2021, different rules … Continue Reading
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
