Brexit continues to add complexity to the Medical Device and IVD industry as manufacturers and importers get to grips with the latest regulations. For those in the EU, it is important to understand the latest requirements, specifically on the UK Responsible Person (mandatory since 1.1.2021) and product registration (to be completed in 2021) to ensure your products remain compliant.
This short training course examines the latest Brexit device regulations and guidelines to ensure your product is compliant on the UK market. You will examine the UK conformity Assessment and the UKCA mark, comparing it the CE mark. Once completed, you will have also a comprehensive understanding of the UK responsible Person and the product registration requirements so you can plan your regulatory strategy.
You are encouraged to complete the pre-course assessment which gives you the opportunity to submit your Brexit concern. We will look to cover this during the course.