An extensive round-up of medical device regulatory news from November 2024 includes new and updated guidance documents, Q&As, and directives from Europe and the US, including the new EU Product Liability Directive for AI and Smart Products.

The resolution represents a non-binding legal intention to consider further changes.

Scientific innovations and technology applications to transform medical devices or pharmaceutical products in the future

Pure Global is proud to announce its inclusion in the China Business Service Providers (BSP) directory on the International Trade Administration website.

This week in medical device regulatory news, Thailand has introduced new refer and transfer guidelines, Europe released an updated Q&A on IVDR and MDR vigilance terms, and Romania has new rules for Economic Operators.

This week, we bring you medical device regulatory update coverage from around the world, including new registration Q&A resources in Taiwan and Japan, UK relaunches ILAP pathway, Mexico will apply a new acquisition model, and more.

Key deadlines and questions in vitro diagnostic manufacturers need to consider to comply with IVDR Amendment EU 2024/1860.

This week in medical device regulatory news, EU parliament moves toward a revision of the EU MDR, the UK enhances post-market surveillance requirements, US FDA prioritizes guidance revisions for 2025, and more.

A necessary evil of a medical device company’s post-market responsibilities.