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EU General Court clarifies interpretation of “satisfactory method” in the context of orphan medicinal products

European Union, United Kingdom - October 29 2020 In the recent case of Medac Gesellschaft für klinische Spezialpräparate mbH v European Commission, the EU General Court has annulled a decision of…

Dr. Gareth Morgan.

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.

MHRA updates guidance on withdrawal of notified body services (UK)

European Union, United Kingdom - February 7 2020 The Medicines and Healthcare products Regulatory Agency (MHRA) has recently issued guidance for situations where a notified body withdraws all, or…

Chris Bates, Hannah Curtis, Shuna Mason.

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.

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.