Medical Devices

New EU Regulation Extends Financial Penalties to Entities Beyond the Marketing Authorization Holder and Updates the Legal Framework for Medicinal Products for Human Use

By Geneviève Michaux & Luca Salernitano on January 28, 2019

Posted in European Union, Medical Devices

Regulation (EU) 2019/5, which was published a few days ago in the Official Journal of the European Union, amends the EU pharmaceutical legal framework by firstly complementing new Regulation 2019/6 on veterinary products that repeals Directive 2001/82/EC on veterinary medicinal products and incorporating the provisions on veterinary products contained in Regulation 726/2004 (in particular, Articles 30 to 45), thereby …
Continue Reading New EU Regulation Extends Financial Penalties to Entities Beyond the Marketing Authorization Holder and Updates the Legal Framework for Medicinal Products for Human Use

The Medical Devices Regulation – Key Dates and Roadmap for the Implementation of the New Rules

By Dr. Ulrich Worm on February 6, 2018

Posted in European Union, Medical Devices

The Regulation (EU) 2017/745 on Medical Devices (MDR) entered into force in 2017. Although most of the provisions will only apply as of 26 May 2020, the time for impact assessments, such as content-related evaluations of the new legal text and approaches to the implementation of the MDR has begun. On 13 November 2017, the…