The Technical & Regulatory Update for July 2024 is now available in the Members Hub of the BDIA website.
This month’s update features Northern Ireland’s 10 year derogation from the EU’s amalgam phase-out, updated MDCG guidance on standardisation, the publication of the EU’s AI Act and US FDA draft guidance on dental composites and curing lights.
UK & EU
- Government secures 10 year derogation from EU amalgam phase-out for Northern Ireland
- Revised MDCG guidance on standardisation for medical devices
- Updates to EU MDR published in Official Journal
- EU Artificial Intelligence Act published
- Recording of EU MDR information session for international regulators.
International
- US FDA guidance on use-related risk analyses for combination products
- US FDA guidance for drug delivery devices
- US FDA guidance addresses medical misinformation
- IMDRF guiding principles for Artificial Intelligence and Machine Learning
- US FDA 510(k) draft guidance for dental products.
