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What do companies supplying IVDs to the UK market need to know about the IVDR?

United Kingdom - May 23 2022 In three days’ time (on May 26, 2022), the EU Regulation on In-vitro-Diagnostic Medical Devices (the “IVDR”) becomes applicable in Europe. But what…

Grant H. Castle, Roderick Dirkzwager

In review: the life sciences regulatory regime in United Kingdom

United Kingdom - February 23 2022 This article reviews the essential regulatory considerations surrounding medicines and medical devices in United Kingdom, including clinical trials and marketing authorisations.

Grant H. Castle

Spotlight: medicine and medical device pricing and reimbursement in United Kingdom

United Kingdom - February 23 2022 An examination of the key legal and practical issues surrounding the pricing and reimbursement of medicinal products and medical devices in United Kingdom.

Grant H. Castle

U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices

Canada, United Kingdom, USA - October 29 2021 On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products…

Olivia Dworkin, Ellie Handy

Consultation on the Future Regulation of Medical Devices in the UK, including Work Programme for Software and AI Medical Devices

United Kingdom - September 20 2021 The Medicines & Healthcare products Regulatory Agency (“MHRA”) has published a “Consultation on the future regulation of medical devices in the United…

Ellie Handy