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The Medical Device Coordination Group (“MDCG”) has issued guidance on the safe making available of medical device software (“MDSW”) apps on online platforms (MDCG 2025-4). MDCG 2025-4 outlines the regulatory roles of online...more
The European Union Agency for Cybersecurity (ENISA) has launched the European Vulnerability Database (EUVD), a tool designed to enhance digital security across the EU. The EUVD is available here....more
The EU Cyber Resilience Act (CRA), adopted by the European Parliament in 2024, marks a major milestone in European cybersecurity legislation. As the first EU-wide law focused on the cybersecurity of digital products, it...more
The European Commission published guidelines that clarify the definition of AI systems under the AI Act, analyzing each component of the definition of AI system, providing examples and specifying which systems should be...more
The CRA will affect a broad range of digital products placed on the EU market (including by those based outside the EU), including connected hardware/devices, software and remote data processing solutions. The EU has adopted...more
Bob Dylan famously asked, “How many roads must a man walk down, before you can call him a man?”. The power of the question is that there is no answer – and comparing the tribulations of one person’s journey through life to...more
Dramatic changes to EU product liability rules are expected to drive an increase in litigation....more
On 20 November 2024, the EU Cyber Resilience Act (CRA) was published in the Official Journal of the EU, kicking off the phased implementation of the CRA obligations....more
On October 10, 2024, the EU Cyber Resilience Act ("CRA") was adopted by the Council of the European Union....more
Our webinar explored liability that can be incurred from the creation use or deployment of AI systems and raised some important questions around the current and future regulatory landscape applicable to AI and liability. We...more
Our Privacy, Cyber & Data Strategy Team highlights 11 common questions your company’s senior executives may have about the European Union’s Artificial Intelligence Act and how you can answer them....more
On May 30, 2024, the Benelux Chapter of the Association of Certified eDiscovery Specialists (ACEDS) hosted a highly anticipated event in collaboration with Reveal and Houthoff in Amsterdam. This exclusive gathering brought...more
On September 15, 2022, the European Commission published its Proposal for a Cyber Resilience Act (CRA) which sets out new requirements for hardware and software products in the EU. The CRA applies to hardware and...more
In Part 6 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will govern medical devices software (“MDSW”) in the EU, we turn to the...more
In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed...more