IVD Directive (IVDD) to IVD Regulation (IVDR) Transition Training Course

There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC), and will impose new requirements on manufacturers and other Economic Operators.

This long awaited text brings a number of significant changes to the regulatory requirements for IVD manufacturers, addressing the challenges posed by the IVD Directive. The changes include a new rule-based classification system, increased scrutiny of technical documentation, and improved traceability of devices through the supply chain.

Our one day training course has been designed to introduce IVD manufacturers and other Economic Operators in the supply chain to the key changes to requirements for CE marking following the publication of the new IVD Regulation (IVDR).

Who should attend?

  • Medical device manufacturers, especially if your role is in:

• Regulatory Affairs
• Design and Development
• Clinical Affairs Specialists
• Quality Management
• Quality Assurance

  • Authorized Representatives
  • Economic Operators, including importers and distributors
  • Consultants

Pre-requisites: 

You will benefit from having a basic understanding of the IVD Regulation.

The course is aimed at delegates who already have a good knowledge of the existing IVD Directive.

What will I learn?

By the end of this course you will be able to:

  • Explain the background to the IVD Regulation and why the IVD Directive is being replaced
  • Recognize increased responsibilities of economic operators
  • Differentiate between the requirements of the IVD Directive and Regulation, including the classification rules under the new IVD Regulation
  • Recognize conformity assessment routes available under the new Regulation in order to CE mark your products
  • Identify new requirements for clinical evidence and post-market performance follow-up
  • Explain the importance of technical documentation for compliance with the new Regulation

How will I benefit?

This course will help you:

  • Identify the requirements of the new IVD Regulation and how this will impact your organization and other operators
  • Understand the significant changes that are being introduced by the new legislation
  • Learn what needs to be revised in your current arrangements to meet compliance
  • Take steps to ensure that existing products CE marked under the IVD Directive comply with the new regulation
  • Create a plan for your organization to transition to the new regulation for new IVD product development

What's included?

  • Training course notes
  • Lunch 
  • Refreshments

 

In-house training

If you have a group of people to train and a single location that is practical, an expert tutor can deliver training at your premises. Want to know more?

 

Request an in-house training quote >

Course resources

Download course guide (PDF)


COVID-19: Important information on classroom-based training courses

BSI is closely monitoring UK Government Advice regarding the safety of classroom-based training courses. We’ve been working with all our venues to ensure that COVID secure measures are in place and a member of our team has visited each venue to personally check things over. Enhanced cleaning procedures have been implemented, food and beverage offers adapted, and meeting room layouts have been modified to enable socially distanced events – with anti-bacterial gel and wipes readily available.

If you have any questions regarding your booking of a classroom-based training course, please contact training@bsigroup.com or call +44 345 086 9000.


Save on your learning journey with the BSI Training Academy*

With BSI training online, you can unlock discounts when booking your learning pathway, helping you shape your next few weeks, months or years of development – whilst saving in the process.

Make the most of your training budget by booking your next 2 or more courses with BSI before 27 November 2020 and you’ll save:

  • 15% off your next course

  • 20% off your second course

  • 25% off your third course

Contact our training team today to find out more and book your place. Call +44 345 086 9000 or email training@bsigroup.com.

*Terms and Conditions: Applies to all public BSI UK training courses, booked before 27 November 2020 and delivered within 12 months, via Connected Learning Live (online training) only. Call our training team on +44 345 086 9000 or email training@bsigroup.com for more information. Discounts applicable when booking 2 or more courses. Moves, changes and cancellations are not permitted. Payment required or invoice issued at the time of bookings. This offer does not apply to BSI re-sellers or Cybersecurity and BRCGS courses. This offer does not apply to BIM qualifications, where existing course packages are available. Offer is valid for new BSI UK training bookings only. Offer is not to be used in conjunction with any other offer. Offer subject to availability of training courses. Bookings are non-transferable. All other terms and conditions for training courses apply.