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The New EU Regulation on Medical Devices Aims at Enhanced Product Safety and Further Harmonization

On May 5, 2017, the new Regulation on Medical Devices (MDR) and the new Regulation on In Vitro Diagnostics (IVDR) have been published in the European Official Journal. The Regulations will become effective 20 days after...more

The New EU Clinical Trials Regulation Aims at Harmonization and Transparency

On June 16, 2014, Reg. (EU) No. 536/2014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes applicable, the Regulation will provide a comprehensive legal framework for...more

New EU Regulation on Cosmetic Products Enters Into Force

On 11 July 2013 Regulation (EC) No 1223/2009 (Regulation) will replace the Cosmetics Directive of 1976 that used to rule cosmetic products in the European Union. Major aims of the Regulation are health protection, animal...more

EC Introduces Major Changes to Medical Device Regulation

The European Commission has issued two proposals that, if approved, will fundamentally amend EU law on medical devices and in vitro diagnostics. The proposed legislation will significantly broaden the scope of medical device...more

12/19/2012  /  EU , European Commission , Medical Devices
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