This month, an amendment to the Medical Devices Regulations in the UK has come into effect. What does that mean? 

“The government has put in place legislation in Spring 2023 to extend the acceptance of CE marked medical devices on the Great Britain market. This will support the ongoing safe supply of medical devices to Great Britain and ease the transition to the future regulatory framework for medical devices.”

Basically, the most important amendment is that certain CE marked medical devices can continue in the British market for longer. The government has also said it intends to introduce further legislation later in the year to bring into force “strengthened post-market surveillance requirements ahead of the wider future regulatory regime.”

If this affects your product, it’s huge news!