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The EU Cyber Resilience Act (CRA) entered into force on 10 December 2024. The CRA is the first legislation of its kind in the world that aims to enhance the cyber security of products or software with a digital component...more
With under six months to go until the European Union Digital Operational Resilience Act (DORA) becomes applicable on 17 January 2025, DORA implementation projects are running full steam ahead. DORA lays down uniform...more
On June 12, 2024, the United States took several hard-hitting sanctions- and export control-related actions intended to intensify pressure on the Russian government and hamper Russia’s ability to continue to support its war...more
On the eve of the 2024 Group of Seven (G7) Leaders’ Summit, the United States imposed new sanctions and export control measures against Russia further targeting sanctions evaders and, for the first time, the Russian...more
On September 15, 2022, the European Commission (EC) published a Proposal for a Cyber Resilience Act (CRA Proposal) that sets out new rules in the European Union (EU) for software and hardware products and their remote data...more
Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more
On 12 March 2021, the "Code for Children's Rights" ("Code voor Kinderrechten") was launched in the Netherlands. The Code was developed by the University of Leiden and the Waag organisation commissioned by the Dutch...more
The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more
On 12 July 2017, the German Federal Government significantly reinforced the barriers for the acquisition of German companies by non-EU companies. The new Regulation for the Amendment of the Foreign Trade and Payments...more