Course Aim: 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.
Course Description: 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.
How will I 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
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
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:
o Scope and applicability of IVDR
o EU risk classification criteria for IVDs to determine “Risk Class”
o General Safety and Performance Requirements as the basis for CE Marking, including the use of standards and Common Specifications
o Risk Management and related planning
o Technical documentation
o Labelling and UDI
o Conformity assessment routes and their application based on risk-class
o Self-certification, CE-certification by Notified bodies
o Other key Regulations and Directives
o EUDAMED and registration
- Plan post-market activities required by IVDR with respect to:
o Post-Market Surveillance and post-market Follow-Up
o Periodic reports, Vigilance, ad-hoc Reporting
o Risk management throughout the product lifecycle
o Involvement of authorities, scrutiny
o Notification of significant changes
- Impart knowledge concerning IVDR requirements into your organization, e.g. in projects for CE-marking
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
- This training content will be delivered via BSI’s Connected Learning Live Platform as a virtual classroom with the BSI tutor. This will provide the delegate with the flexibility of attending it from the convenience of home or office, without travelling to BSI facility. A stable internet connection, headset with USB connection, a quiet and suitable work area. In advance of the training a ‘testing room’ will be provided for delegates to confirm their hardware works and that they can fully participate in the training.
- Examination will be conducted online via an e-assessment platform 'Questionmark'. Invigilation will be done through delegate’s webcam and microphone.
Please Note: This training fee is applicable only for residents of India and the Indian subcontinent.