This online, interactive on-demand course will help you 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.
How will I Benefit?
- 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
What will I learn?
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
Who should attend?
This 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
What will I gain?
On completion, you’ll be awarded an internationally recognized BSI Training certificate.
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.
This course will focus on the overall implementation of the IVDR, and not on specific devices.
Benefits of On-Demand for the individual
Convenient - courses are available 24/7 and you can learn at any time and from any place that suits you – you just need an internet connection
Learning pace - You can learn as fast or as slowly as you want to. You can also take breaks at any time in the course and pick up where you left off when you are ready to continue
Information retention - During the access period, you can go back and repeat parts or all the course to refresh and reinforce what you have learned
High-quality materials - Developed by top subject matter experts, course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning
Requirements of the IVDR
IVD Directive to IVD Regulation Transition
Technical files and design dossiers for In Vitro Diagnostics (IVDs)
Performance evaluation and clinical evidence for In Vitro Diagnostics (IVDs)
Risk Management for medical devices
- Module 1: Introduction and scope of the IVD regulation
- Module 2: Responsibilities of economic operators and other stakeholders
- Module 3: Placing on the market
- Module 4: Risk-based classification
- Module 5: Conformity assessment
- Module 6: Certification
- Module 7: Notified bodies and scrutiny
- Module 8: General safety and performance requirements
- Module 9: Risk management
- Module 10: Performance evaluation
- Module 11: Understanding clinical evidence
- Module 12: Post-marketing surveillance
- Module 13: Vigilance reporting
- Module 14: Technical documentation
- Module 15: Product claims and labelling
- Module 16: EUDAMED and registration
- Module 17: Significant changes to a certified device
- Module 18: EU directives and regulations relevant to the IVD industry
- Module 19: Course review and summary