Training Courses

Medical Device Regulation (MDR) Training Courses

Gain a thorough understanding of the European Union (EU) MDR 2017/745 for obtaining and maintaining the CE marking for medical device products.

Medical Device Regulation (MDR) Training Courses

Level Multiple levels

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

Private training

Request a Training Quote

Become adept in the EU Medical Device Regulation (MDR) and CE marking

Our training will help you and your organization learn the key requirements, concepts, and processes to comply with the EU MDR 2017/745 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.

Get 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 MDR 2017/745. Discover our MDR dedicated training portfolio developed to help you navigate the requirements, implementation, and conformance.

The Medical Device Regulation (MDR) replaced the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) and entered into force on May 25, 2017 with May 26, 2021 as date of application.

Popular Medical Device Regulation (MDR) 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 MDR 2017/245. Get vital insights for regulatory affairs roles across various sectors, facilitating smoother relationships between stakeholders, obtaining compliance with MDR requirements, and enhancing market access within the EU.

See more details and enroll.
This is designed to guide you through MDR implementation. Find out best practices to implement a compliant QMS and prepare a thorough technical documentation package to obtain CE mark for your medical device. Focus on device safety and performance, emphasizing pre-market requirements, conformity assessment, quality management aspects, post-market-surveillance (PMS), transparency and traceability.

See more details and enroll.
Gain insights on how notified bodies may perform a MDR QMS compliance audit, using the topics of a typical MDR audit agenda as the basis. This will enable you to optimize your auditing skills and knowledge to boost your audit capabilities, gain confidence in planning,and performing an effective EU MDR QMS audit, as well as continued compliance to the EU MDR 2017/245.

See more details and enroll.
Get an understanding of the key requirements for medical device technical documentation for the EU MDR 2017/745. Learn how to create documentation that demonstrates compliance to the MDR and meets notified body expectations, avoiding unnecessary delays to the certification process.

See more details and enroll.
Learn to 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 ensuring compliance.

See more details and enroll.
Learn the key requirements, concepts, and overall process for CE marking under the EU MDR 2017/245 on own schedule and pace. Get vital insights for regulatory affairs roles across various sectors, facilitating smoother relationships between stakeholders, obtaining compliance with MDR requirements, and enhancing market access within the EU.

See more details and enroll.
Understand the Risk Classification Requirements as per the EU MDR (2017/745). Discover the reasoning behind classification, the importance of clearly defining the intended purpose, and the crucial role it plays in employing appropriate conformity assessment procedures.

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