Implementation IVDR CE Marking On-demand Training

Implementation Vitro Diagnostic Device Regulation CE Marking On-demand Training

Implementation IVDR CE Marking On-demand Training

Level Implementation Duration 10 hours

Available to book: On-demand elearning 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.

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.

BSI’s on-demand courses are market-leading and available 24/7. Developed by top subject matter experts, they contain the same high-quality content you will find in our tutor-led training, but with the added benefit of being able to learn at your own pace and at any time.

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 organizations 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
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
If you have any enquiries, let us know how can we help you.
Call: +91 80815 80815
Email us: info.in@bsigroup.com
This is an online, interactive eLearning course, You’ll have access to the course for 12 months.

Please Note: This training fee is applicable only for residents of India and the Indian subcontinent.

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