Requirements of the In Vitro Diagnostic Regulation training course

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Requirements of the In Vitro Diagnostic Regulation training course

BSI Group
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Beschrijving

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 saf…

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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. 

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

Combination discount

Attending several medical device courses is associated with special discount:

1. Requirements of the IVDR training course € 800

2. Implementation of the IVDR training course € 2.150

Combination training courses 1 + 2 =€ 2.950 - € 100 discount= € 2.850

In-house training courses

For more information about combination of courses or in-house training courses, please contact our specialists.

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 our Training Advisors.

BSI biedt een grote diversiteit aan praktijkgerichte trainingen. Door onze centrale rol in de commissies waarin de normen tot stand komen, kennen wij de inhoud van een norm tot in detail en zijn wij in staat om u informatie uit de eerste hand te leveren.

Daarnaast weten wij als wereldwijde certificatie-instelling precies hoe organisaties met de normen in hun eigen organisatie om kunnen gaan. Het onderscheidend vermogen van de trainingen wordt o.a. gekenmerkt door de focus op praktijkgericht en effectief leren middels interactieve opdrachten.

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