Requirements of IVDR course - International

Niveau Exigences Durée 1 journée de formation

Disponible pour réserver: Salle de classe virtuelle 1190€ + TVA Book your place

Learn about the key requirements of the new In Vitro Diagnostic Regulation (IVDR EU 2017/746), published in Spring 2017 with a five-year transition period.

To CE mark an IVD in Europe it will soon be mandatory to conform to this Regulation. The Regulation will affect all In Vitro Diagnostic device manufacturers, importers, distributors, and EU Representatives.

Prerequisites

There are no formal prerequisites for this course.

Pedagogical objectives

Identify the key requirements of the In Vitro Diagnostic Regulation
Interpret and communicate the key requirements and expectations of the IVDR to your organization
Identify the next steps in planning of product realization and commercialization in conformity with the IVDR

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 the course, delegates will be able to:
- 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)
- Recognise 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
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Assessment specifics
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
Course materials including:
- Introduction to the training, detailed program and security assignments
- Course presentation, theory and activities/ role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the
  activities
- Attendance sheet to be signed
This guide will give you all the necessary information.
Download our training guide: Requirements of IVDR
* These training modules are eligible to the subsidizing by the public institutions in France (OPCO).

**Each delegate receives a training convention after enrollment.

***Please note that for the public sessions, you have until 48h before the start of the course to confirm your enrollment. For the in-house sessions, the deadline would be of two weeks prior to the start of the course.

****Should you be in a disabled situation, please contact us and indicate what details should be taken into account.

You can contact us on training.france@bsigroup.com or 01 89 79 00 40.

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