UK Medical Device Regulations Delayed for 1 Year

The Medicines and Healthcare products Regulatory Agency (MHRA), the first new body approved in the UK since Brexit, circulated a letter late last week that it intends to extend the current standstill period by 12 months from July 2023 to July 2024. This means that valid CE marks will continue to be accepted in Great Britain and the requirement to obtain a UK Conformity Assessed (UKCA) mark has been delayed until July 2024. MHRA said it intends to introduce the new medical device regulations in July 2024.