Current Medical Device Regulatory Processes

Understand how medical device regulation shapes product development, clinical evidence, quality management, and innovation in healthcare. This module focuses on the European regulatory framework, including the Medical Device Regulation (MDR), the In Vitro Diagnostic Regulation (IVDR), and the AI Act, while also introducing international perspectives such as the U.S. FDA framework.

Key Facts

Qualification

5 ECTS credits 
upon successful completion of the module exam

Course start

1 October 2026

Duration

tba

Course location

Online

Course format

Hybrid: synchronous and asynchronous study

Credit points

5 ECTS

Language

English

Course fee

€1,668

This module is designed for professionals who want to understand how regulatory frameworks influence the development, evaluation, approval, and use of medical devices.

It is particularly suitable for:

• Professionals in medical technology, digital health, diagnostics, software as a medical device, and AI-enabled healthcare technologies
• Specialists working in regulatory affairs, quality management, clinical evaluation, product development, or risk management
• Managers, project leads, and experts who need to align technology and business strategies with regulatory requirements
• Professionals interested in MDR, IVDR, the AI Act, and international regulatory frameworks
• Startups and innovators who want to better understand regulatory barriers, approval pathways, and market entry requirements

The module is especially relevant for those who want to assess regulation not only as a compliance requirement, but also as a strategic factor in product development, innovation, competitiveness, and healthcare transformation.

The module provides participants with a clear and applied understanding of the regulatory frameworks governing the development, evaluation, and use of medical devices. Students examine the European regulatory framework, including the Medical Device Regulation (MDR), the In Vitro Diagnostic Regulation (IVDR), and the AI Act.

Further topics include regulatory strategy, documentation requirements, software life-cycle processes, benefit–risk analysis, in-house development, complex high-risk technologies, and international comparison with regulatory systems such as the U.S. FDA framework.

Curriculum at a Glance

EU Regulatory Frameworks: MDR, IVDR, AI Act, guidance documents, standards, and regulatory requirements
Regulatory Affairs in Practice: classification, conformity assessment, clinical evaluation, evidence generation, and documentation
Quality & Risk Management: quality management systems, risk-assessment methodologies, benefit–risk analysis, and software life-cycle processes
Innovation & Market Access: regulatory strategy, product development, reimbursement context, competitiveness, and barriers to innovation
International Comparison: U.S. FDA framework, global regulatory policy, harmonization, reliance efforts, and international standards

Content

The module covers current medical device regulatory processes, with a primary focus on the European Union. Students learn how MDR, IVDR, and the AI Act are structured, what they require, and how they affect medical technology development and innovation.

A further component is the connection between regulatory science and practical regulatory affairs. Students examine how regulatory affairs and quality management departments are structured in companies and how regulatory strategies are linked to product development, clinical evidence generation, quality management, and risk management.

The module also addresses challenges and limitations of current regulatory frameworks. These include administrative and documentation burden, pressure on EU competitiveness, barriers to digitalization and AI-enabled innovation, and specific considerations for in-house development and complex high-risk technologies.

Qualifications

Participants who successfully complete the module will be awarded 5 ECTS points. The credit points are awarded after passing the module examination.

The general admission requirements set out in the examination regulations must be met. In preparation for face-to-face events, literature recommendations may be provided. The content of this literature may be assumed as prior knowledge or should be acquired during the module.