Tag Archives: MHRA

UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation

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

MHRA creates new expert advisory group on medical devices

On 18 July 2014, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that it will create a new independent Devices Expert Advisory Committee (DEAC) before April 2015. The DEAC will be responsible for providing independent expert advice to help the MHRA regulate medical devices.  The MHRA hopes that the DEAC will help the MHRA … Continue Reading

New UK Guidance on Software as a Medical Device

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on software as a medical device, including apps.  The guidance aims to assist those working in healthcare, and software developers, to determine whether a specific piece of stand-alone software or an app constitutes a medical device.  The MHRA provides illustrative examples of software, … Continue Reading

New MHRA Guidance on Borderline Medical Devices

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 … Continue Reading

Transfer of Responsibility of Certificates of Free Sale for UK Medical Devices Scheme

With effect from 1 April 2014, the UK Government is proposing to transfer responsibility for the Certificates of Free Sale (CFS) for medical devices scheme from the UK Department of Health to the UK Medicines and Healthcare Products Regulatory Agency (MHRA).  The UK Government issued a consultation relating to the proposed transfer, which closed on … Continue Reading

UK NICE Considers Restrictions on Hip Replacement Implants

The UK National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending tightening standards for hip replacement devices.  If adopted, the tougher standards could force the National Health Service (NHS) to stop using a significant number of existing devices, with obvious impacts on manufacturers of these products.… Continue Reading

New UK Tracking System for High-Risk Devices in Development

The Medicines and Healthcare products Regulatory Agency (MHRA) announced on June 7, 2013 that four National Health Service hospitals have agreed to pilot a new tracking system for high-risk medical devices.  The system is one of 11 projects established by the Agency to strengthen the regulation of medical devices following a government review into the problems … Continue Reading
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