Implementation of the IVDR for CE Marking  

BSI will tell about 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.

Course objective and outcome
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.
 
Content

  • 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

 Who should attend

  • 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

Trainer
Marco Rost, BSI Tutor
 

 

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Kontakt

mp@medicoindustrien.dks billede
Morten Petersen
Uddannelseskonsulent
49184703