The UK medical devices regulator has announced a consultation on a pre-market statutory instrument to be completed by the end of 2024.
Hot on the heels of the UK government’s announcement that the medical devices post-market surveillance statutory instrument (SI) will be laid in parliament by the end of this year, the regulator has put another major piece of structural work on the table: a consultation on the core regulations as laid out in January in the regulatory roadmap.
This key set of regulations, now referred to by the Medicines and Healthcare products Regulatory Agency (MHRA) as the “pre-market...
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
