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Medical Devices: Brexit and the UK Responsible Person
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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

This course is currently not scheduled however it can be delivered for your team. To register your interest, complete the form below

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Register your interest in the course. When we schedule dates, we will be in touch.

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

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.

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

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

Dates TBC

1-Day Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered online.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

 

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.

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