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Time to Prepare for New EU Medical Device Regime

United Kingdom, European Union - May 24 2019 On 26 May 2020, Regulation (EU) 2017745 on medical devices (MDR) will become fully active, reflecting an overhaul of the current regulatory framework...

Oliver Mobasser, Christoph W.G. Engeler, Henrietta J. Ditzen, Héctor Armengod, Gail E. Crawford, Robbie McLaren.

MHRA Releases No-Deal Brexit Guidance for Life Sciences Companies

United Kingdom, European Union - April 4 2019 The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a significant volume of guidance documents on various aspects of the...

Oliver Mobasser, Christoph W.G. Engeler, Henrietta J. Ditzen, Héctor Armengod, Gail E. Crawford, Robbie McLaren.

EDPB Clarifies Use of Consent and Other Legal Grounds for Clinical Trials, but Challenges Remain

United Kingdom, European Union - March 25 2019 European regulators are expected to align their processes and guidance to accommodate the EDPB’s recommended approach to processing special categories...

Mihail Krepchev, Gail E. Crawford.

EDPB Clarifies Use of Consent and Other Legal Grounds for Clinical Trials, but Challenges Remain

United Kingdom, European Union - March 22 2019 In January, the European Data Protection Board (EDPB) issued an opinion (Opinion) on the interplay between the General Data Protection Regulation...

Mihail Krepchev, Gail E. Crawford.