Many answers to regulatory questions can be found at BfArM.
The most frequent questions and answers in connection with the coronavirus have been summarized by the European Commission: Guidance on medical devices [...] in the COVID-19 context
Medical devices that are already registered inside the EEA through a European authorized representative do not need an additional registration at MPI and can be sold in Germany! Please, also see § 5 and § 25 MPG (German Medical Devices Act).
For information on how to check the validity of certificates or registrations please visit Service.
Notifications of Medical Devices and In vitro Diagnostics
Notifications on the first placing medical devices on the market and on the safety officers, pursuant to §§ 25 and 30 section 2 MPG, are to be reported using the internet-based registration system.
The Medical Devices Information System enables the reporting person to enter the data directly. Checking routines support the accurate notification input and therewith guarantee for a high degree of data quality. After the data is forwarded by the person reporting, the competent authority is automatically informed by e-mail, the notification processed and released to the database. An automatic e-mail is sent to the person obligated to notify confirming that the data has been released to the database by the competent authority.
Please note, that the entire Medical Devices Information System is in German language.
Access to the Medical Devices Information System
The person reporting has to request access authorisation (user code) for the Medical Devices Information System. Click on the right on the link "apply for a user code". You will find a detailed guidance on the following site: User code application.
When the person reporting accesses the system for the first time and has filled out the initial notification address (Erstanzeige Adresse), the user code assigned will be linked with a special "Anzeigenden-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.
Data entry by the Person obligated to notify
The entire Medical Devices Information System is divided into different individual areas. There are separate areas specific to the notification of medical devices and in vitro diagnostics (according to § 25 Medical Devices Act, MPG). Each area consists of three components.
- Neue Anzeige (new notification)
After selecting the option "Neue Anzeige" (new notification), the type of notification is set and then the data can be entered. These will then be verified within the system for completeness and formal correctness. A notification can only be saved or forwarded once the person obligated to notify have carried out all the corrections suggested by the system. The competent authority can only view and process the data once it has been forwarded by the reporting person. The person obligated to notify have exclusive write access in all the fields they have to fill out.
- In Bearbeitung (in progress)
The "In Bearbeitung" (in progress) option provides the reporting person with the possibility to research, edit or even delete their own stored but not yet forwarded notifications. Furthermore, stored or registered initial notifications for products can be used as a template. By verifying the access rights, it is ensured that the competent authority cannot access notifications that are still being processed by the reporting person. The competent authority can only view the data after it has been forwarded to them.
- Datenbestand (database)
The "Datenbestand" (database) option allows the person reporting to research their notifications that are registered by the competent authority and provides support with the preparation of notifications of change or withdrawal. The data from a researched notification are then adopted in the new form for the preparation of a notification of change. This ensures the automatic allocation of the initial and notification of change.
Another option can be selected at any time through the navigation bar. After the reporting person has entered and forwarded the data, the system automatically informs the competent authority of the corresponding notification per e-mail.
Further Handling by the Competent Authority
After examining the notifications the authority's predetermined mandatory fields (e.g. registration no. and date of registration) are to be completed. The data sets are released individually and are available online for the circle of users named in § 5 DIMDIV after the daily database update has been carried out. An automatic e-mail is sent to the person obligated to notify confirming that the data has been released by the competent authority. The competent authority only has write access to its own specified data fields.
Nomenclatures for Medical Devices
A standard nomenclature for medical devices is required to support the regulatory exchange of information within the framework of the Medical Device Act (MPG). Currently, the German version of the Universal Medical Device Nomenclature System (UMDNS) is to be used for medical devices, and for in vitro diagnostics, the English classification from the European Diagnostic Manufacturers Association (EDMA). These nomenclatures are integrated into the Medical Devices Information System by means of a search function, but can also be downloaded free of charge as individual files.