German Medical Devices Information and Documentation System (DMIDS) (BfArM)

Overview and Purpose

The Deutsche Medizinprodukte-Informations- und Dokumentationssystem (DMIDS) is the central electronic portal managed by BfArM for handling notifications, registrations, and documentation requirements for medical devices in Germany. It serves as the national interface for economic operators, competent authorities, and other stakeholders to fulfill obligations under the EU Medical Device Regulation (MDR) and national implementing legislation (MPDG). DMIDS supports efficient data exchange, vigilance reporting, and market surveillance while facilitating integration with the European EUDAMED database. DMIDS - BfArM

Key Functions and Modules

DMIDS provides several core functionalities:

• Operator Registration: Manufacturers, authorised representatives, importers, and distributors register to obtain a Single Registration Number (SRN) or German-specific identifiers where applicable.
• Device Notifications: Submission of device data, including UDI-DI and core datasets for certain products (especially during EUDAMED transition phases).
• Vigilance Reporting: Electronic reporting of serious incidents, field safety corrective actions (FSCA), and field safety notices (FSN) to BfArM as the national competent authority.
• Clinical Investigations: Notifications and data exchange for clinical investigations of medical devices under MDR Article 62.
• Market Surveillance: Tools for competent authorities to coordinate inspections, enforcement actions, and information sharing.

Transition to EUDAMED and National Role

While EUDAMED is the primary EU database under MDR, DMIDS continues to serve as the national fallback and complementary system during phased EUDAMED rollout:

• Certain obligations (e.g., vigilance reports, operator registration) are routed through DMIDS until full EUDAMED modules are mandatory.
• BfArM uses DMIDS data to fulfill national responsibilities and feed information into EUDAMED where required.
• Full integration ensures seamless data flow between national and EU levels.

Access and Usage

• Access is granted via secure authentication (ELSTER certificate or equivalent).
• Manufacturers and operators must use DMIDS for submissions unless directly via EUDAMED (once fully operational).
• BfArM provides user guides, FAQs, training materials, and support contacts for registration and submission processes.

Benefits and Compliance Support

DMIDS enhances transparency, traceability, and rapid response to safety issues in the German medical devices market. It supports manufacturers in meeting regulatory obligations and enables BfArM to perform effective oversight. Regular updates and guidance ensure alignment with evolving MDR requirements and EUDAMED progress.

This national system remains a key pillar of medical device regulation in Germany, bridging national needs with EU harmonization. DMIDS - BfArM