Combination Products

Combination products include a combination of a medical device, and a drug (and/or biologic – only US). This module aims to provide participants with knowledge of the regulatory requirements for each component of a combination product including their similarities and differences. It will additionally provide participants with an understanding of combination product market launch considerations.  

Learning objectives

• You understand the definitions in the EU and the US and familiarizes with the regulatory frameworks,
• You understand regulatory requirements for each component of a combination product including their similarities and differences,
• You understand use cases of combination products (e.g. diagnostic or therapeutic),
• You understand the types and use cases of Combination Products,
• You understand important standards and guidelines,
• You know how to categorize and distinguish different medical device software (e.g. standalone, embedded, accessory, etc.) familiar with new regulatory developments (e.g., AI Act EU),
• You are sensitized to moral and ethical issues (algorithm bias, representative data, hallucination, etc.),
• You know how to apply transition timelines in EU,
• You know how to structure technical documentation (eCTD vs. MDR Annex II, STED, ToC, etc.)

Scope & duration

3 ECTS points
This is equivalent to roughly 75-90 working hours

Start

The module takes place in spring term each year.

📍On-site events take place at sitem-insel in Bern, Switzerland.

Please feel free to contact the School if you have any more detailed questions.

Fee

This module can be attended as single course at a fee of CHF 3'150.-
👉 Contact the School if you are interested in this module as a single course.