Requirements of the In Vitro Diagnostic Regulation (IVDR) Training Course

The In Vitro Diagnostic Regulation details the requirements which manufacturers have to meet to sell In Vitro Diagnostic devices in the European Union.  It replaces the In Vitro Diagnostic Directive. 

This course introduces you to the key requirements of the IVDR. IVDs will now be classified according to their risk using a new rule-based system. The majority of IVDs will be subjected to independent assessment of their conformity to the Regulation by a Notified Body and will require third-party certification for the first time.

The course explores the four risk classifications and the conformity assessment routes for IVDs. It defines the Technical Documentation required, and the product safety and performance expectations, including requirements on clinical evidence, Post-Market Clinical Follow-up (PMCF) and Post-Market Surveillance (PMS). Traceability of devices through the supply chain and product labelling will be reviewed during the course.

Please note: This course does not cover Medical Devices under the Medical Devices regulation (MDR EU2017/745).


Who should attend?

Manufacturers of In Vitro Diagnostic devices, in particular those who have not yet placed an IVD on the market in the EU, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, Quality Assurance personnel, and other Economic Operators including manufacturers, importers, distributors and authorized representatives who are new to, or have little familiarity with, the EU IVD market. 

By the end of this course delegates will be able to define the:

  • Identify devices that are within scope of the Regulation
  • Understand the roles and responsibilities of the different Economic Operators identified by the Regulation
  • Identify other key players and their obligations under the Regulation
  • Identify key requirements concerning the following steps for conformity assessment:
    • Determine the risk class of IVD
    • Select conformity assessment procedure
    • Identify applicable General Safety and Performance Requirements (GSPRs)
    • Recognize key elements of Technical Documentation
    • Appreciate the importance of product claims, labelling, Unique Device Identification (UDI) and EUDAMED (The European Database on Medical Devices)
    • Identify requirements of clinical evidence
    • Post-Market Surveillance and updates

Practical information

  • It's a 1-day course
  • The training and materials will be provided in English
  • This course will focus on the overall new legal framework of the IVDR, and not on specific devices
  • Lunch and drinks are included

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.

Combination discount

Attending several medical device courses is associated with special discount

No.

Training

Price

 

1

 Requirements of the In Vitro   Diagnostic Regulation (IVDR)   Training Course

    € 750

 

2

 Implementation of the In Vitro   Diagnostic Regulation (IVDR)   Training Course

    € 1.950

 

 

 Total

    € 2.700

 

 

 

 

 

 

 

 Investment

 Discount

 

 Combination training 1 + 2 

€ 2.600

€ 100

For more information about combination of courses or in-house training courses, please contact Mark Leenaers via +31 20 346 07 83 or send an email to mark.leenaers@bsigroup.com


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