[The German Medical Devices Information System containing over 100,000 documents].

Area of Science:

• Medical Device Regulation
• Health Informatics
• Public Health Surveillance

Context:

• Legal framework for medical devices in Germany.
• Establishment and structure of a national information system.
• Implementation of electronic reporting for device certification.

Purpose:

• To present the legal basis, objectives, and setup of the German Medical Devices Information System.
• To demonstrate the online registration system's functionality using MPG Section 18.
• To explain information flow via an email-based messaging system.

Summary:

• Details the legal foundations and setup of the German Medical Devices Information System.
• Illustrates the online registration process for medical device certification (MPG Section 18).
• Highlights the system's high performance in managing extensive medical device data.

Impact:

• Ensures compliance and transparency in the medical device sector.
• Facilitates efficient data management and information exchange.
• Provides a foundation for future national and European system developments.