In vitro diagnostic regulation training courses (IVDR)

In vitro diagnostic regulation training courses (IVDR)

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The In Vitro Diagnostic Regulation (IVDR) replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application.

Discover our IVDR dedicated training portfolio developed to help you navigating IVDR transition from requirements to implementation.

Course list

Implementation of the in vitro diagnostic device regulation for CE marking training course >

Designed to guide you through IVDR requirements implementation to obtain and maintain the CE mark for in vitro diagnostic medical devices. Learn more about IVD classification rules and conformity assessment routes. Increase your knowledge on General Safety and Performance Requirements in product development, performance evaluation and clinical evidence.

€3075 IVA

3 day public classroom

Requirements and implementation of in vitro diagnostic regulation (IVDR) for CE marking training course >

This course will guide you through IVDR requirements implementation. Find out best practices to implement a compliant QMS and prepare a thorough Technical Documentation package to obtain CE mark for in vitro diagnostic medical devices.

€3995 IVA

3 day public classroom

Medical device qualification pathways

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Why BSI?

  • Trained 70% of the top 100 medical device companies
  • Medical Device Qualifications
  • Internal expertise
  • Global scale
  • A full scope Notified Body

Not sure what course is right for you?

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