BfArM - Federal Institute for Drugs and Medical Devices
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If you use the services of this provider, it is possible that usage data will be collected and, if necessary, stored in server logs.The BfArM has no influence on the type and scope of the transmitted or stored data. Go to LinkedIn
If you use the services of this provider, it is possible that usage data will be collected and, if necessary, stored in server logs.The BfArM has no influence on the type and scope of the transmitted or stored data. Go to LinkedIn
Notification of Medical Devices and In vitro Diagnostics
Notifications on the placing of medical devices on the market and on the person responsible for regulatory compliance (PRRC), pursuant to § 96 MPDG and §§ 25 and 30 MPG, are to be reported using the online registration system.
The German Medical Devices Information and Database System (Deutsches Medizinprodukte-Informations- und Datenbanksystem, DMIDS) enables the reporting person to enter the data directly. Check routines support the accurate data input and therewith guarantee for a high degree of data quality. After the data are being forwarded, the competent authority is automatically informed by e-mail, the notification is processed and transferred to the database. An automatic e-mail is sent to the reporting person confirming that the competent authority has released the data into the database.
Please note that the entire information system is in German language!
Functionality of EUDAMED
The European Commission published the notice of functionality of the first four EUDAMED modules (Actors, UDI/Devices, NB/Certificates and Market Surveillance): Commission Decision (EU) 2025/2371.
The publication of the notice of functionality will trigger the mandatory use of the four modules as of 28 May 2026.
Until that time, the use of DMIDS remains mandatory.
The person reporting has to request access authorisation (user code) for the information system. You will find a detailed guidance on the following site: Operating the system.
Specific guidances on the process of submitting notifications on products and addresses are available for download at Portals - DMIDS. You can also find them directly in the system with the "Servicelinks" at the bottom underneath the form.
When the person reporting accesses the system for the first time and has filled out the initial notification address (Erstanzeige Adresse), the assigned user code will be linked with a special "Anzeigender-Code" (notifier code). This automatic linking of user code and notifier code ensures that the person reporting is only able to access and edit their own notifications.
A standard nomenclature for medical devices is required to support the regulatory exchange of information. Since MDR and IVDR are effective, the European nomenclature EMDN is to be used. EMDN is implemented in EUDAMED but not selectable in DMIDS; though it can be inserted in a free text field.
When will devices have to be registered in EUDAMED / when will the use of EUDAMED become mandatory?
Products must continue to be registered in DMIDS until EUDAMED becomes mandatory on 28 May 2026. This will be followed by a six-month transition period, after which all MDR and IVDR products and legacy devices (still on the market on the date of mandatory use) must be registered in EUDAMED. Automatic data transfer from DMIDS to EUDAMED is not possible.
Are there general registration obligations for distributors (e.g. pharmacies)?
In a European context, the MDR and IVDR allow the member states to adopt national rules for the registration of distributors (including pharmacies). In a national context, the German Medical Device Law Implementation Act (MPDG) authorises the Federal Ministry of Health to adopt corresponding rules in an ordinance (Section 88 (1) no. 9 MPDG). Such an ordinance has not yet been published (as of August 2024).
Please note that the BfArM is not responsible for legal matters and therefore cannot provide guidance on this topic.
Do importers have to register with DMIDS?
Please refer to Article 13 of Regulation (EU) 2017/745 and Article 13 of Regulation (EU) 2017/746 for the general obligations of importers under the MDR and IVDR (effective date 26 May 2021 and 26 May 2022):
German importers are only required to register in the European database EUDAMED. Further information on the registration can be found on the website of the EU Commission: EUDAMED information centre
In a national context, there is no legal basis and no obligation for importers to register in DMIDS. The role of "importer" refers exclusively to the responsibility described in § 5 MPG and is no longer valid under the current legal situation.
