AI ACT for Medical Device and IVD Manufacturers

Course Details

Scheduled Events: Coming soon 2027
Learning Mode: Online
Language: English
(see more details below)

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Learning Objectives

The course aims to achieve the following objectives:

• Identify the regulatory framework applicable to medical devices and in vitro diagnostic devices that include AI-based technologies
• Deepen the concept of High-Risk AI Systems, with a focus on the interplay between MDR/IVDR regulations and the AI Act, including references to MDCG 2025-6
• Provide basic knowledge regarding the concepts of Artificial Intelligence, AI Systems, deployers, and providers in accordance with the AI Act
• Explore general concepts such as Transparency, Data Governance, Record Keeping, Human Oversight, Accuracy, Robustness, and Cybersecurity, and their applicability to medical and in vitro diagnostic devices

Who should attend?

This training is intended for the following target group: Manufacturers of medical devices and in vitro diagnostic devices containing software or stand-alone software that includes AI-based technologies; Quality Management and Regulatory Affairs professionals; software and system designers, interface/usability and requirements designers, and IT service providers for medical devices.

Course Agenda

• Regulatory framework for medical devices and IVDs with AI technologies.
• High-risk AI systems: definition according to the AI Act and classification criteria.
• Basic concepts of the AI Act: definition of AI, AI systems, roles, and responsibilities of operators.
• Horizontal principles and requirements of the AI Act.
• During the course day, practical examples and exercises will be carried out to apply the illustrated principles.
• Final exam is scheduled at the end of the course.

Prerequisites

A solid understanding of European regulatory requirements in the field of medical devices and in vitro diagnostic devices is recommended (Regulations (EU) 2017/745 and (EU) 2017/746).

Suggested readings include:

• MDCG 2019-11 guideline: “Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR”
• The position paper “Questionnaire: Artificial Intelligence in medical devices”, published by Team NB in collaboration with the German Notified Bodies Alliance for Medical Devices

Course Materials

• Handout, containing the slides projected during the course, in case of online courses it will be provided in electronic format;
• Notebook for didactic use (where applicable), containing a copy of the standards necessary for the training course, to be returned at the end of the course. In order to respect copyright, all the standards of online courses can be provided for consultation only through access to a dedicated portal. For a higher quality of teaching and preparation for exams (where applicable) it is advisable that participants purchase the reference standard directly from the official ISO store https://www.iso.org/home.html or request a copy within their own organisation.

Learning Assessments

• Certificate of competence, in case of successful completion of final exam
• Certificate of attendance, in case of non successful completion of final exam or no exam.

Duration

8 hours.

Scheduled Events

• The course sessions will be scheduled for 2027.

Price

950,00 € (per participant, taxation excl.).

Learning Mode

Online, Instructor-Led

Language

Training in English Language