Implementation of IVDR for CE Marking - International Training

Niveau Mise en œuvre Durée 3 journées de formation

Disponible pour réserver: Salle de classe virtuelle 2410€ + TVA View dates and book your training

The In Vitro Diagnostic Devices Regulation (IVDR 2017/746) is the legislation detailing the requirements which manufacturers have to meet to place in vitro diagnostic devices on the market in the European Union.

The Regulation contains detailed requirements that need to be implemented, and will affect all IVD manufacturers, importers, distributors and EU Representatives.

The IVDR focusses on devices to be safe and effective, emphasizing pre-market requirements, conformity assessment, post-market-surveillance (PMS), and traceability.

This course aims to offer guidance on implementation of the requirements stipulated in the IVDR into your business.

Prerequisites

Participants must have an understanding of the requirements in the IVDR, for example conveyed through our IVDD to IVDR transition course, or the 1 day Requirements of the IVDR training course.

Participants would benefit from an understanding of European In Vitro Diagnostic Device legislation, or some experience in pre-or post-market activities within the EU.

Pedagogical objectives

Take the necessary steps for your organization to meet the IVDR requirement
Implement the requirements of the European In Vitro Diagnostics Devices Regulation
Execute robust and compliant performance evaluation and post market follow up studies
Guide and support other people and partner organisations affected by IVDR

- RA, QM, and QA professionals who will be implementing the IVDR within their organisations
- Personnel concerned with certification or active in projects for CE-marking, including R&D scientists, production personnel, project management.
- Staff in contact with IVD Device manufacturers at companies which are partners to manufacturer, e.g. as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, auditee
By the end of the course delegates will be able to:
- Develop a strategy for regulatory compliance as stipulated by IVDR
- Recognise the roles and responsibilities of Economic Operators (legal manufacturer, Authorised representative, Importer and Distributor) and other Key Players (Notified Body, Competent Authority, significant subcontractors) under the IVDR
- Explore the role of the Notified Body
- Implement requirements concerning the following steps for Placing on the Market:
  
  Scope and applicability of IVDR
  
  EU risk classification criteria for IVDs to determine “Risk Class”
  
  General Safety and Performance Requirements as the basis for CE Marking, including the use of standards and Common Specifications
  
  Risk Management and related planning
  
  Technical documentation
  
  Labelling and UDI
  
  Conformity assessment routes and their application based on risk-class
  
  Self-certification, CE-certification by Notified bodies
  
  Other key Regulations and Directives
  
  EUDAMED and registration
- Plan post-market activities required by IVDR with respect to:
  
  Post-Market Surveillance and post-market Follow-Up
  
  Periodic reports, Vigilance, ad-hoc Reporting
  
  Risk management throughout the product lifecycle
  
  Involvement of authorities, scrutiny
  
  Notification of significant changes
- Impart knowledge concerning IVDR requirements into your organization, e.g. in projects for CE-marking
- 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 programme 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: Implementation of IVDR for CE Marking
* 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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