Let’s throw in some more cliches, there are still many plates spinning, balls in the air and how long is a piece of string? For seven years or so, participants in the medical device market have had to contend with an ever-changing regulatory environment and uncertainty about the long-term future, whether it was the move to Virtual Manufacturing, Brexit, the introduction of EU MDR, updates to the ISO13485 standard or is the upcoming UK legislation. The legislators have tried to help with lengthy transition period but these in themselves keep slipping and changing.
In late July, the UK Government published an update on the ‘Implementation of the Future Regulations’ (updated 27th July 2023). The good news is that this finally confirms the extension of the acceptance of CE marked medical devices on the GB market. The bad news, well there is still no firm date for the publication of the new UK legislation and the WTO have entered the fray. The subject of post- market surveillance is common to discussions relating to EU MDR, the updated ISO13485, etc and the above update outlines the UK government’s intention to introduce strengthened PMS requirements in late 2023, which will be ahead of the wider regulatory update. It also advises that the WTO has published a notification of the draft Post Market Surveillance Statutory Instrument, giving members 60 days to comment. PMS is obviously a vital part of medical device regulation and patient safety but let’s hope all of these different strands come together as a unified whole.