On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and machine learning (“AI/ML”).
Purpose
AI
The Medicines & Healthcare products Regulatory Agency (“MHRA”) has published a “Consultation on the future regulation of medical devices in the United Kingdom” (the “Consultation”), which will run until 25 November 2021. The consultation sets out proposed changes to the UK medical device regulatory framework with the aim to “develop
On 6 May 2021, the European Commission published its “EU Strategy on COVID-19 Therapeutics” (the “Strategy”). With the vaccination programme now under way, the EU is shifting focus towards the development, approval and procurement of COVID-19 therapeutic products. The Commission intends to build on the experience from the EU vaccines strategy. In particular, the aim is to have three new therapeutics available by October 2021 and possibly two further products by the end of the year.
The Strategy touches on a number of key areas for both biotechnology and pharmaceutical companies operating in the space:
Continue Reading European Commission outlines Strategy on COVID-19 Therapeutics
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:
On 23 April 2020, the European Parliament and Council approved the European Commission’s proposal to delay the application date of the Medical Device Regulation 2017/745 (the “MDR”) by one year (from 26 May 2020 to 26 May 2021) by adopting New Regulation (EU) 2020/561 (the “New Regulation“).
Unusually, the New Regulation took effect
The European Commission published today its proposal for the European Parliament and the Council to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) by one year. This publication comes only 9 days after the Commission announced its plans to postpone the MDR (see the InsideEULifeSciences blog post here). The European Parliament
The European Commission has announced today that it is working on a proposal to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) for one year. This proposal is to relieve the pressure on national authorities, notified bodies, manufacturers and other actors so they can focus on responding to the COVID-19 outbreak. According
On 23 March 2020, the Department of Health and Social Care (“DHSC”) issued a plea to technology companies to come up with digital support solutions for COVID-19. The DHSC is making £500,000 available, with funding of up to £25,000 per company. The challenge, named TechForce19, aims to increase community support for the elderly, vulnerable
The Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a specification for a “Rapidly Manufactured Ventilator System” (“RMVS”), setting out the clinical requirements for a ‘minimally acceptable’ ventilator for use in hospitals during the COVID-19 outbreak (the “RMVS Specification”). The purpose of the RMVS Specification is to meet the UK healthcare system’s increased demand
France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of recommendations released by a national regulator in Europe that apply cybersecurity considerations specifically to medical devices. The full ANSM draft guidelines, ‘Cybersécurité des dispositifs médicaux intégrant du logiciel au cours de leur cycle de vie’ (‘Cybersecurity of medical devices integrating software during their life cycle’) published 19 July 2019, is available in French here, and in English here.
The draft guidelines note that while the European regulatory framework (the Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017 /746) has been modified “in line with technological developments” (e.g. “data exchange, monitoring, risk prediction and control software”) to include software within the definition of a medical device, and accompanying security and performance requirements specific to such medical devices incorporating software, the “[medical device and in vitro diagnostic medical device r]egulations do not explicitly refer to or elaborate on the notion of cybersecurity”. For the purposes of the guidelines, ‘cybersecurity’ is described as “the full set of technical or organisational measures set up to ensure the integrity and availability of a [medical device] and the confidentiality of the information held on or output by this [medical device] against the risk of targeted attacks.”
Continue Reading French medicines regulator produces first in Europe medical devices cybersecurity guidelines