This guidance has been updated by the Australian Government and can be found here.
Ben KempJuly 10, 2025
A reminder for members that applications for the second round of the MHRA AI Airlock programme close on 14 July 2025. The first round saw four breakthrough AI technologies, including software that could help doctors create personalised cancer treatment plans, and a tool to help hospitals, AI developers, and regulators monitor AI performance in real time, tested in a regulatory…
Ben KempJuly 8, 2025
Corrigendum to Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) View article...
Ben KempJuly 4, 2025
Release note v 2.15.0 Jun 26, 2025 The new version of EUDAMED 2.15.0 has been deployed. The Information Centre – EUDAMED (Production) provides the full release note document here: EUDAMED Release Note (v2.15) and the full documentation on the release is available as follows: Welcome to the EUDAMED Information Centre. DTX: The XSD schema for this release has the following version: 3.0.16. The release affects the…
Ben KempJuly 4, 2025
Dear members, this could potentially impact some manufacturers regarding some very specific raw materials derived from animals. I’m aware of at least one material derived from sharks that could be impacted. Council Decision (EU) 2025/1314 of 23 June 2025 on the submission, on behalf of the European Union, of proposals for amendments to the appendices to the Convention on International…
Ben KempJuly 4, 2025
This is an additional legislation regarding relaxation of tariff codes, which relaxes tariffs, except for Russia and Belarus, but again does not to mixtures, components or products. Council Regulation (EU) 2025/1303 of 23 June 2025 amending Regulation (EU) 2021/2278 suspending the Common Customs Tariff duties referred to in Article 56(2), point (c), of Regulation (EU) No 952/2013 on certain agricultural…
Ben KempJuly 4, 2025
Are you looking for a concise yet comprehensive overview of the most impactful state-level data protection laws affecting US businesses right now? The advancement of technology has amplified the need for robust data protection, and with 144 countries already having national privacy laws, the US states are rapidly catching up. We've developed a crucial resource to help you…
Ben KempJuly 4, 2025
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
You can find the document here.
Ben KempJuly 4, 2025