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EU Medical Device Coordination Group Publishes Guidance on the Qualification and Classification of Software under Upcoming Medical Device Regulations

European Union - October 21 2019 The EU’s regulatory rules for medical devices are due to change on 26 May 2020, when the new Medical Device Regulation (“MDR”)1 comes into effect...

Raj Gathani.

Commission relaunch of eHealth Stakeholder Group

USA - August 21 2019 On 13 August 2019, the European Commission opened a call for expression of interest to relaunch the eHealth Stakeholder Group with a view to...

Kate Kinchlea.

The CJEU Rules that Companies Can Seek Orphan Status for a New Product Containing the Same Active Substance as an Existing Orphan Product

European Union - July 30 2019 On July 29, 2019, the Court of Justice of the European Union ("CJEU") issued its judgment in Case C-35918 P, Shire Pharmaceuticals Ireland v. EMA...

Grant H. Castle.

French medicines regulator produces first in Europe medical devices cybersecurity guidelines

European Union, France - July 24 2019 France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released Draft Guidelines...

Harriet Fletcher, Delphine Marchal.

UK’s NICE releases newly updated Digital Health Technologies (DHT) Evidence Standards Framework

United Kingdom - March 19 2019 Following on from the Evidence Standards Framework for DHTs published in December 2018 (the Original Standards, as reported in our previous blog post...

Daniel Pavin, Harriet Fletcher.