Training Courses

In Vitro Diagnostic Regulation (IVDR) Training Courses

Gain a thorough understanding of the European Union (EU) IVDR 2017/746 for obtaining and maintaining the CE mark for medical device products.

In Vitro Diagnostic Regulation (IVDR) Training Courses

Level Multiple levels

Enroll on our Learning Marketplace: Public training See all IVDR courses

Private training

Request a Training Quote

Become adept in the EU Medical Device Regulation (IVDR 2017/746)

Our training will help you and your organization learn the key requirements, concepts, and processes to comply with the EU IVDR 2017/746 and the CE marking. Whether in-person or virtual, our live sessions use accelerated learning techniques, securing your thorough comprehension through interactive workshops and lectures. Also see our on-demand e-learnings and free webinars for flexible learning options.

Gain essential knowledge to understand the regulatory affairs of medical devices in the EU and the demands of the suppliers, subcontractors, importers, and distributors, allowing better relationships between them and manufacturers.

Get European market access for medical devices.

All medical devices will need to undergo a conformity assessment procedure in order to be placed on the European Union market. Learn the requirements for CE marking under the IVDR 2017/746. Discover our IVDR dedicated training portfolio developed to help you navigate the requirements, implementation, and conformance.

The In Vitro Diagnostic Regulation (IVDR) replaced the In Vitro Diagnostic Directive (IVDD) and entered into force on May 26, 2017 with May 26, 2022 as the date of application.

Popular In Vitro Diagnostic Regulation (IVDR) training courses

Our most popular courses are listed below with brief descriptions and links to our BSI Learning Marketplace for more details and to enroll.

Learn the key requirements, concepts, and overall process for CE marking under the EU IVDR 2017/246 for getting in vitro diagnostic medical devices in the European market. Explore the four risk classifications and the conformity assessment routes.

See more details and enroll.
Get guidance for IVDR requirements implementation to obtain and maintain the CE mark for in vitro diagnostic medical devices. Learn about IVD classification rules and conformity assessment routes. Increase your knowledge on general safety and performance requirements in product development, performance evaluation, and clinical evidence.

See more details and enroll.
Learn the requirements of the European medical device directives (90/385/EEC, 93/42/EEC, 98/79/EC), standards, and guidance documents to enable effective implementation of a post-market surveillance system. Post-market surveillance, including clinical follow-up, complaints, and vigilance handling, are vital in promoting compliance.

See more details and enroll.
Learn the key requirements, concepts, and overall process for CE marking under the EU IVDR 2017/246 at your own schedule and pace. Understand how to get in vitro diagnostic medical devices into the European market. Explore the four risk classifications and the conformity assessment routes.

See more details and enroll.
Get guidance on your own schedule and pace for IVDR requirements implementation to obtain and maintain the CE mark. Learn about IVD classification rules and conformity assessment routes. Increase your knowledge of general safety and performance requirements in product development, performance evaluation, and clinical evidence.

See more details and enroll.
Get an understanding of what the IVD regulation is, why it’s important, and how you can help your organization comply with this regulation.

See more details and enroll.

Our training programs can help you and your organization inspire growth.

Do you have questions about our courses or enterprise programs? Contact our team at 1-800-217-1390 or submit an inquiry.

Get in touch