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.
Please note: This course does not cover Medical Devices under the Medical Devices regulation (MDR EU2017/745). We offer an equivalent training course for the Requirements of the Medical Device Regulation for CE Marking.
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:
1. Requirements of the In Vitro Diagnostic Regulation (IVDR) Training Course - € 845,-
2. Implementation of the In Vitro Diagnostic Regulation (IVDR) Training Course - € 2.150,-
| Price | Discount | |
| 1. Requirements of the IVDR training course | € 845 | |
| 2. Implementation of the IVDR training course | € 2.150 | |
| Total | € 2.995 | |
| Combination training courses 1 + 2 | € 2.895 | € 100 |
In-house training courses
For more information about this course and/or the possibilities of an in-house training for your organization, please contact our Training Advisors on 0031 (0)20 346 0780 or send an email to training.se@bsigroup.com.
Who should attend?
Manufacturers of In Vitro Diagnostic devices, in particular those who have not yet placed an IVD on the market in the EU, especially: Regulatory Affairs, Design and Development, Clinical Affairs Specialists, Quality Management, Quality Assurance personnel, and other Economic Operators including manufacturers, importers, distributors and authorised representatives who are new to, or have little familiarity with, the EU IVD market.
Delegates will be able to define the:
- 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)
- Recognise 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
Practical information
- It's a 1-day course
- The training and materials will be provided in English
- This course will focus on the overall new legal framework 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.
