Understand the role of the UK Responsible Person to ensure continued access to the UK market
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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.
90 mins | 10.30am UK
Medical Device Regulations in the UK post Brexit
90 mins | 1pm UK
Brexit and the UK responsible person
Mika Reinikainen has a Master’s degree in Law from the University of Nice and later gained a Master’s in Business Administration from the Wharton School.
He has more than 30 years of experience managing European medical device regulatory affairs in industry, as a healthcare legal counsel and as a regulatory consultant. He has also been involved directly in the development of the Medical Devices Directives and of technical standards since the 1990s.
He founded the medical device consulting company Abnovo Ltd in 2007 to provide a wide variety of networked services to the medical device industry worldwide. He is currently a member of various medical device expert working groups of the European Commission and is Chairman of the European Association of Authorised Representatives (EAAR).
Mika is a founder and current Chairman of the UK Responsible Persons Association (UKRPA) set up following the Brexit transition outcome. He is working closely with the MHRA and is well placed to advise on the latest UK Brexit guidelines.
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This product has multiple variants. The options may be chosen on the product page
This product has multiple variants. The options may be chosen on the product page
This product has multiple variants. The options may be chosen on the product page