Implementation of the In Vitro Diagnostic Device Regulation

for CE Marking Training Course

Implementation of the In Vitro Diagnostic Device Regulation

Level Implementation Duration 3 day

Available to book: Instructor led training £2965 + VAT View dates and book now

To help implement the requirements of the European In Vitro Diagnostic Device Regulation (IVDR 2017/746) to obtain and maintain the CE mark for your product. Gain confidence with the IVD classification rules and the conformity assessment routes. Learn the importance of the General Safety and Performance Requirements in product development, and of scientifically robust performance evaluation and clinical evidence.

Explore the role of risk management during product development and in post market follow up. Develop an understanding of the interface and interaction with Notified Bodies, economic operators (importers, distributors, EU Representatives) and subcontractors/suppliers, according to their obligations under the IVDR.

How will you benefit?

This course will help you:

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

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
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
- You will gain 8 CPD points on completing the course
- Training course notes

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