Francesca Pisacane

At the international level, the regulatory landscape for medical devices is constantly evolving. For all stakeholders, this means staying informed about new developments and adapting internal processes in a timely manner. On May 7, 2026, the European Commission, the Council, and the European Parliament agreed on a reform of the AI Regulation. In its press...

At the international level, the regulatory landscape for medical devices is constantly changing. For all stakeholders, this means staying informed about new developments and adapting internal processes in a timely manner. With this brief “Update on the Medical Device Regulation,” we would like to summarize some important developments at the EU level. Several EUDAMED systems...

If a manufacturer of personal protective equipment within the meaning of Article 3 of Regulation (EU) 2016/425 (PPE Regulation) engages a testing company as part of the conformity assessment procedure for its products, it must accept responsibility for any fraudulent conduct on the part of that testing company. This has been decided by the ruling...