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).
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
How will I learn?
This is an online, interactive on-demand course.
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.
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
During the access period, you can go back and repeat parts or all the course to refresh and reinforce what you have learned.
The course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning.
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.
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
What is included?
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
Contact Us
If you have any enquiries, let us know how can we help you.
Call: +91 80815 80815
Email us: info.in@bsigroup.com
Notes:
Please Note: This training fee is applicable only for residents of India and the Indian subcontinent.
