IVD Directive 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

By the end of the course delegates will be able to know the:

  • Requirements and impacts of new IVDR
  • Key aspects of the transition - from Directive to Regulation
  • Changes to responsibilities of Economic Operators
  • Significant changes introduce by the new IVDR
  • Revised scope, risk-based classification, and conformity assessment
  • Revised clinical expectations
  • Managing the transition
  • New expectations for post-market activities
  • Technical documentation for compliance

 

Combination discount

Attending several medical device courses is associated with special combination discount.

  Price Discount
1. Transition or Requirements MDR - IVDR € 800  
2. Implementing CE Marking MDR - IVDR € 2.150  
     
Combination training 1 + 2  € 2.850 € 100

For further information regarding reduced rates at the hotel where the training is being conducted please contact training.nl@bsigroup.com or call +31-(0)20-346 0780.

Online training courses

Do you prefer the convenience of an online training course? BSI offers training courses online via Connected Learning Live. 

Read more about Connected Learning Live

In-house training courses

For more information about combination of courses or in-house training courses, please contact our Training Advisors via +31 20 346 07 80 or send an email to training.nl@bsigroup.com.

Practical information

  • It's a 1-day course.
  • The training and materials will be provided in English
  • Lunch and drinks are included
  • On completion, you'll be awarded an internationally recognized BSI Training Academy certificate.

 

In-house training courses
For more information about this course and/or the possibilities of an in-company training for your organization, please contact our Training Advisors on 0031 (0)20 346 07 80 or send an email to training.nl@bsigroup.com.