IVD Directive to IVD Regulation (IVDR) Transition training course

Course overview

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

 

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.

For further information regarding reduced rates at the hotel where the training is being conducted please contact training.nl@bsigroup.com or 0031-(0)20-3460780

In-company

We can deliver this training course to your team in-house. Training in-company allows you to save on each individual delegate and also cut out travel and accommodation expenses, which can be significant.With our in-company training, not only can you meet your business needs, but you can also:

  • Refresh your team’s skills and boost their confidence
  • Give your team an overview of your management system(s)
  • Train a group of auditors to the same level, using the same consistent techniques

For more information about the in-company training or to request a quote, please contact Mark Leenaers via +31 (0)20 346 07 83 or send an email to mark.leenaers@bsigroup.com.