The In Vitro Diagnostic Regulation details the requirements which manufacturers have to meet to sell In Vitro Diagnostic devices in the European Union. It replaces the In Vitro Diagnostic Directive.
This 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.
The course explores 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.
Please note: This course does not cover Medical Devices under the Medical Devices regulation (MDR EU2017/745).
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
2. Implementation of the In Vitro Diagnostic Regulation (IVDR) Training Course
| 1. Requirements of the IVDR training course |
| 2. Implementation of the IVDR training course |
| Total |
| Combination training courses 1 + 2 |
In-house training courses
For more information about combination of courses or in-house training courses, please contact our specialists via +31 20 346 0780 or send an email to training.nl@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 authorized 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)
- 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
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 the classroom training
For further information regarding reduced rates at the hotel where the training is being conducted please contact training.nl@bsigroup.com or 0031-(0)20-346 0780.
