In the last month, both the European Data Protection Board (“EDPB”) and the Court of Justice of the European Union (“CJEU”) provided their interpretation of key data protection concepts that are crucial for ensuring compliance with Regulation (EU) 2016/679 (“GDPR”). In Opinion 22/2024, the EDPB…

The European Commission has opened the floor for a discussion on whether the EU medical devices legislation is effective, efficient, relevant, coherent and valuable. The Commission aims to assess the performance of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics…

The European Commission (‘Commission’) has published a Questions & Answers (‘Q&A’*) document on the new obligation to notify interruptions or discontinuations of the supply of medical devices under the Medical Devices Regulation (Regulation (EU) 2017/745, ‘MDR’) and the In Vitro Diagnostic Medical Devices Regulation (Regulation (EU)…

The European Union has for the first time introduced measures to facilitate the development of medical devices for rare conditions, and has recently published the Medical Devices Coordination Guidance on the clinical evaluation of orphan devices (the MDCG Guidance). Key aspects of the document…

On 23 October 2024, the European Parliament adopted a resolution on the urgent need to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). This resolution acknowledges that the MDR and IVDR were adopted to strengthen the regulatory framework for medical…