sitem-insel AG

M10 - Combination Products

Module leaders: Beat U. Steffen, confinis ag



Date and Credits

Start: 17.01.2022

Duration: 7 Weeks

3 ECTS

Combination products include a combination of a medical device, and/or drug and/or biologic. Module 10 will cover the corresponding regulatory requirements for each component, their similarities and differences. The market launch of a combination product on the market will be discussed.


Learning objectives

  • To know the definition a combination product
  • To understand the types of combination products
  • To be familiar with the regulatory framework for combination products
  • Learn about the consequences of MDR and transition timelines
  • To know how to structure a technical documentation for combination products

Learning content

  • Introduction to combination products
  • The regulation of combination products in the US and EU and changes with the MDR
  • Stakeholders, design controls, and technical documentation
  • General safety and performance requirements for combination products
  • Risk management for combination products
  • Regulatory requirements for devices containing an ancillary medicinal product versus drug delivery devices
  • Human factors and usability engineering for combination products
  • Post-Market Surveillance (Pharmacovigilance vs. Materiovigilance)