Requirements and Implementation of the In vitro Diagnostic Regulation for CE Marking training course
Learn about the key requirements of the new In Vitro Diagnostic Regulation (IVDR EU 2017/746), published in Spring 2017 with a five year transition period. To CE mark an IVD in Europe it will soon be mandatory to conform to this Regulation. The Regulation will affect all In Vitro Diagnostic device manufacturers, importers, distributors and EU Representatives.
This first day of the course introduces you to the key requirements of the IVDR. IVDs will now be classified according to their risk using a new rule-based system. The majority of IVDs will be subjected to independent assessment of their conformity to the Regulation by a Notified Body and will require third-party certification for the first time.
You will explore the four risk classifications and the conformity assessment routes for IVDs. It defines the Technical Documentation required, and the product safety and performance expectations, including requirements on clinical evidence, Post-Market Clinical Follow-up (PMCF) and Post-Market Surveillance (PMS). Traceability of devices through the supply chain and product labelling will be reviewed during the course.
The rest of the course aims to offer guidance on implementation of the requirements stipulated in the IVDR into your business. 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.
Please note: This course does not cover Medical Devices under the Medical Devices regulation (MDR EU2017/745).
Who should attend?
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
We also offer an equivalent training course for requirements and implementation of the Medical Device Regulation for CE Marking.
What will I learn?
By the end of the course delegates will be able to:
- Identify devices that are within scope of the Regulation
- Understand the roles and responsibilities of the different Economic Operators identified by the Regulation
- Identify other key players and their obligations under the Regulation
- Identify key requirements concerning the following steps for conformity assessment:
- Determine the risk class of IVD
- Select conformity assessment procedure
- Identify applicable General Safety and Performance Requirements (GSPRs)
- Recognize key elements of Technical Documentation
- Appreciate the importance of product claims, labelling, Unique Device Identification (UDI) and EUDAMED (The European Database on Medical Devices)
- Identify requirements of clinical evidence
- Post-Market Surveillance and updates
- 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-markin
How will I benefit?
This course will allow you to:
- Identify the key requirements of the In Vitro Diagnostic Regulation
- Interpret and communicate the key requirements and expectations of the IVDR to your organization
- Identify the next steps in planning of product realization and commercialization in conformity with the IVDR
- 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
- You will gain 8 CPD points on completing the course
- Training course notes