The draft regulations, “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023,” serve as an amendment to the existing UK MDR Part 4A post market surveillance requirements, and are currently with the World trade Organisation (WTO) for member comments.
The UK is an appealing market for MedTech businesses, but there are some important issues that companies will need to be familiar with to ensure they fully understand the UK regulatory landscape. The role of the UK Responsible Person is one of the most important.
This article highlights what manufacturers should prioritize and areas in which new information may still emerge, along with providing a starting point for businesses that need to familiarize themselves with the UK Conformity Assessed marking requirements.
Uncertainty caused by Britain’s EU departure creates opportunity for its neighbor.