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Digital Health - The New Regulation of Medical Software and Apps

European Union, United Kingdom - December 13 2018 The new Medical Devices Regulation 2017/745 (“MDR”), which comes into force in May 2020, represents a huge overhaul of the regulatory framework…

Sarah Hanson, Shuna Mason.

Shire v EMA: Clarification on orphan designation for products with the same active substance

European Union - April 24 2018 On 22 March 2018 the EU General Court handed down its judgment in Case T-80/16 Shire Pharmaceuticals Ireland Ltd v European Medicines Agency (EMA)…

Dr. Gareth Morgan.

New MHRA guidance on Brexit implementation period and the lifesciences sector

United Kingdom - August 15 2018 On 6 August 2018, the MHRA released new guidance on what the Brexit implementation period means for the lifesciences sector, as well as an update on…

Chris Bates, Shuna Mason.

MDR - Agreements with third party contract manufacturers

European Union, United Kingdom - March 6 2020 The EU Medical Device Regulation, which comes into force on 26 May 2020, will lead not only to big changes in how medical devices are regulated, but…

Chris Bates, Hannah Curtis, Shuna Mason.

ASA Adjudications Snapshot - January 2016

United Kingdom - February 25 2016 An ad for Dylon headed “14 Laundry fails We’ve All Experienced” was seen on the entertainment and news website Buzzfeed and as such was styled as a…

Stuart Helmer, Susan Barty, Tom Scourfield.