Implementation of the IVDR for CE Marking Training Course

Niveau Implementatie Duur 3 days

Beschikbaar om te boeken: Virtuele training geleid door instructeur €2650 View dates, locations and prices

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.

Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.

Combination discount

Attending several medical device courses is associated with special discount.

1. Transition or Requirements IVD - IVDR

2. Implementing CE Marking IVDR

Total

Combination training courses 1 + 2

In-house training courses
For more information about combination of courses or in-house training courses, please contact our Training Advisors via +31 20 346 0780 or send an email to training.nl@bsigroup.com

- 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
The course is especially suitable for:
- 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
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.
- It's a 3-day course
- The training and materials will be provided in English
- This course will focus on the overall implementation of the IVDR, and not on specific devices
- Lunch and drinks are included for the classroom training
For further information regarding reduced rates at the hotel where the training is being conducted please contact training.nl@bsigroup.com or 0031-(0)20-346 0780.

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