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.
This course aims to offer guidance on implementation of the requirements stipulated in the IVDR into your business.
Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.
Combination discount
Attending several medical device courses is associated with special discount.
| Price | Discount | |
| 1. Transition or Requirements IVD - IVDR | € 845 | |
| 2. Implementing CE Marking IVDR | € 2.150 | |
| Total | € 2.995 | |
| Combination training courses 1 + 2 | € 2.895 | € 100 |
In-house training courses
For more information about combination of courses or in-house training courses, please contact our Training Advisors via +31 20 346 0780 or send an email to training.se@bsigroup.com
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
Prerequisites:
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.
We also offer an equivalent training course for implementation of the Medical Device Regulation for CE Marking.
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
Practical information
- It's a 3-day course
- The training and materials will be provided in English
- This course will focus on the overall implementation of the IVDR, and not on specific devices
- Lunch and drinks are included
For further information regarding reduced rates at the hotel where the training is being conducted please contact training.se@bsigroup.com or 0031-(0)20-346 0780.
