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Medical Devices: Brexit and the UK Responsible Person

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Understand the role of the UK Responsible Person to ensure continued access to the UK market

If you would like training for yourself or a group, complete the form above

Course Overview

 

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.

Learn more about how we deliver live online training.

What is included?
  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Key Learning Objectives

 

  • Examine the latest UK Brexit laws, regulations and guidance documents
  • Review the role of the UK Responsible Person
  • Familiarise yourself with the product registration requirements
  • Understand the role of the MHRA in regulating Medical Device and IVDs
  • Discover the latest timelines for implementation to align your strategies accordingly
  • Examine conformity assessment in the UK and learn more about the UKCA mark
  • Develop a step by step roadmap to implement post training for you products/company

 

Session 1

90 mins | 10.30am UK

Medical Device Regulations in the UK post Brexit

  • Overview of Brexit and Medical Device Regulatory Affairs
  • Review of the source documents including: laws, regulations, guidance documents.
  • Examine the role of the MHRA
  • Review the implementation timeline
  • Examine conformity assessment
    • Conformity assessment bodies
    • UKCA mark and differences with CE marking
    • Safety and performance requirements
Session 2

90 mins | 1pm UK

Brexit and the UK responsible person

  • Product registration
  • Examining the role of the UK Responsible Person
    • Review the definition
    • Responsibilities
    • Comparing it to the EU Responsible Person
  • Analyse the impact on importers
    • Review strategies to minimise disruption
  • Special status of Northern Ireland
  • Develop a next step checklist for you to implement post training

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.

This course is specifically designed for EU device/IVD companies wanting to ensure their device remains compliant in the UK. Job functionalities who may be of interest include: Regulatory Affairs | Management | Device Manufacturers | Device Distributors.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

 

Complete our contact form by following the link. Get in touch.

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• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training
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