CE Marking Changes in the UK: highlights and pointers for MedDev manufacturers
IMed Consultancy Ltd
QA/RA Medical Device & IVD Consultancy UKRP - QMS - MDR - IVDR - ISO 13485 - CE Marking - Global Submissions - UKCA
On the 1st August 2023, the UK Government announced that they intend to continue to recognise CE marking across England, Wales and Scotland, indefinitely, beyond December 2024[1].
This decision has brought relief to many industries, ensuring a smoother transition as the UK moves forward independently. However, amidst the news coverage, confusion has arisen, especially in the MedTech sector, as the announcement does not encompass CE-marked medical devices or In-vitro diagnostic devices (IVDs).
The UK Government has made it clear that different rules apply to certain sectors, including medical devices. This means that the announcement of continuing recognition for the CE marking does not automatically extend to CE-marked medical devices. For clarity, the relevant departments responsible for medical devices have or will communicate their specific plans in due course.
In our latest blog, Jade Fraser , RA consultant, will shed light on the matter and provide clarity on transitional timelines and requirements.
Discover more about CE marking changes for MedDev manufacturers here and make sure to follow us to keep up with regulatory changes and continue delivering safe and innovative medical devices to patients and healthcare professionals alike.