Regulatory Expertise for Medical Devices & IVDs

Our Executive Briefings provide a concise overview of strategic issues and help you clarify priorities and next steps. White papers cover regulatory topics in greater detail. Practice overviews make technical concepts easy to understand at a glance. Practice guides offer concrete advice for day-to-day work and collaboration.

Select the document that interests you. You can download our practice overviews directly as PDF files. For executive briefings, white papers, and practice guides, you will first be directed to a page with additional information and a form you can use to request the download.

These resources are primarily intended for decision-makers at medical device and IVD manufacturers—including those in executive management, regulatory affairs, quality management, development, and clinical affairs. Depending on the topic, they support strategic decision-making or specific regulatory tasks. The MDR Practical Guide, developed in collaboration with VDMA HealthTech, is also intended for suppliers to medical device manufacturers.

The Executive Briefings are available in German and English (English: on the English-language resources page). The practical guide “MDR Product Life Cycle Reporting” is in English. The MDR white papers and the practical guide from the VDMA collaboration are currently available only in German. Information regarding the language can be found at the top of this page next to each document. The available English translations can be found on the English-language resources page.