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EU in vitro Diagnostic Medical Device Regulation Overview Part 3

European Union - February 7 2017 This publication is the third in a series of three that examines the new European Union (EU) regulations governing Medical Devices and in vitro…

Aline Doussin, Maren Ebner, Joachim Heine, Colleen Hermann, Sarah H. Stec, John E. Wyand

Brexit Implications: Life Sciences

European Union, United Kingdom - July 14 2016 On 24 June 2016, the UK voted to leave the European Union (EU), marking the beginning of a difficult journey towards official exit from a bloc it has…

Aline Doussin, Sarah H. Stec

EU Medical Device and IVD Regulations Overview Series - Part 1

European Union - January 31 2017 Representing one of the largest medical device markets in the world, the European Union (EU) recently underwent a significant regulatory shift. In…

Aline Doussin, Maren Ebner, Joachim Heine, Colleen Hermann, Sarah H. Stec

The Medical Device Regulation, COVID-19 and Brexit

European Union, United Kingdom - February 4 2021 Regulation 2020/561 (Regulation) was passed by the EU in April last year to take account of issues raised by the COVID-19 pandemic and to defer the…

Ian Tully, John E. Wyand

New Rules for Medical Devices and In Vitro Diagnostic Medical Devices in Europe

European Union - June 28 2016 On May 25, 2016, the European Union (EU) agreed on the new rules that will govern the placing on the European market of medical devices and in vitro…

Aline Doussin, Maren Ebner, Joachim Heine, Sarah H. Stec