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.
General Information Medical Devices Information System
With its barrier-free (according to BITV, German Barrier-free Information Technology Ordinance), graphical user interface the Medical Devices Information System contributes to the market surveillance of medical devices in Germany. Based on the German Medical Devices Act (MPG), persons reporting and sponsors register and edit the required forms via the intuitively operated interface and refer them to their respective competent authority.
User code application
To receive access to the Medical Devices Information System you need an individual access authorisation, consisting of the user code and the password. The process of the application of a user code is explained in the following.
Click the button "apply for a user code" on the right. Fill the form and click on "weiter" (continue). You can choose your own usercode and password. Enter your address data and click on "weiter" (continue). The data you entered appears in a new window for verification. When you have checked the correctness of your data, click on "weiter" (continue). A confirmation will be shown that you have completed the process successfully and you will be sent an e-mail containing further instructions.
Click the button "Medical Devices Information System" and the following access page. Enter your user code and password and click on "Anmelden" (login).
Structure and Operating Controls
The navigation bar at the left edge of the screen enables easy access to the desired areas and through the opening of submenus, it shows the area you are currently in. Possible actions are triggered by clicking on the labelled coloured buttons, e.g. "speichern und weiter" (save and continue), "bearbeiten" (edit) and "Datei hochladen" (upload file).
The entry of information in the data fields takes place in form sections arranged like a register. The mandatory fields, i.e. fields that must be filled out, are indicated with an orange-coloured point (•). In every form section, a plausibility check and storing of the entered data takes place by clicking the "speichern und weiter" (save and continue) button. By clicking the button "Formulareingabe abbrechen" (cancel form entry), the data entered in the current form section are deleted. The entered data remains in those form sections that have previously been stored.
When the mouse pointer touches an information symbol [i] beside the data field name, an additional help text is shown for the corresponding data field.
After clicking the "speichern und weiter" (save and continue) button, formally false or missing entries in the form sections are indicated through yellow highlighting of the respective data field and a specific error prompt text. The next form section follows only once all data have been entered correctly. All of the entered data are shown in the last section of each form, "Kontrolle" (Control). By clicking the "bearbeiten" (edit) button, each respective form section can still be corrected.
In the "Nutzereinstellungen" (user settings) navigation point, you can individually configure different system parameters, e.g. changing the password, time specification for automatic logout when inactive, highlighting of search terms, number of search results displayed.
When you (as a sponsor) access the system for the first time, you have to fill out the "Erstanzeige Adresse" (initial notification address). Your user code assigned by DIMDI will be linked with a special sponsor code (= notifier code). This automatic linking of user code and sponsor code ensures that you are only able to access and edit your own notifications.
Please note, that the entire Medical Devices Information System is in German language.
Login to the MD-information system with your user code and password. When logging in for the first time, you will be automatically forwarded to the "Adresserfassung" (address registration).
The automatically generated form number is shown at the top of form section 1. Grunddaten (basic data). Please make note of this form number for later enquiries. If you only want to submit applications for CI/PE, select the organisation type "Sponsor" under "Anzeigender KL/LP" (notifier CI/PE). The indication of the sponsor refers to all types of sponsors (manufacturer, representative, other). The type of sponsor only needs to be specified in the application form for a concrete clinical study. Then click the "speichern und weiter" (save and continue) button.
In the form section 2. Behörde (authority), select the competent authority(ies) responsible for your investigation(s). The information symbol [i] shows you the jurisdiction of the competent authorities (BfArM and PEI). Then click the "speichern und weiter" (save and continue) button.
For the form section 3. Anzeigender (notifier), the data from your user code application are carried over. Make sure that all mandatory fields are filled out properly. You can correct false entries here. Then click on "speichern und weiter" (save and continue).
The form section 4. Sicherheitsbeauftragter (safety officer) is deactivated, since the information on the safety officer is not required for address registration exclusively for clinical investigations/performance evaluations.
Verify all of the entered data in the form section 5. Kontrolle (control). By clicking the "bearbeiten" (edit) button, every individual form section can still be corrected.
At the end of the control section, confirm that you have entered all information according to the best of your knowledge and belief and enter the date (preset), city and name. Then click the "Anzeige weiterleiten" (submit notification) button.
You will receive a confirmation page and an e-mail confirmation that your address notification has been duly received by DIMDI.
The "Klinische Prüfungen" (clinical investigations) area of the Medical Devices Information System consists of three components:
- Erfassung (Entry)
The option "Erfassung" (Entry) allows the sponsor to enter the data for initial applications for approval or notifications of change. The entered data will be verified within the system for completeness and formal correctness if necessary. An application can only be saved or forwarded by the sponsor once all the corrections suggested by the system have been carried out. The competent authority (BfArM or PEI) and the Ethics Committee can only view and process the data once it has been forwarded by the sponsor. The sponsor has exclusive write access in all the fields he has to fill out. After the sponsor has entered and forwarded the data, the system automatically informs the competent authority (BfArM or PEI) and Ethics Committee of the corresponding application per e-mail.
- In Bearbeitung (in progress)
The "In Bearbeitung" (in progress) option provides the sponsor with the possibility to research, view, edit or delete if necessary their own stored applications/notifications before they have been finally registered by the authorities. After having filled in the form completely, it can be saved only or forwarded to the competent authority (BfArM or PEI). The status of a form can be seen in the overview table. By verifying the access rights, it is ensured that the competent authority and the Ethics Committee cannot access applications/notifications that are still being processed by the sponsor and vice versa. The competent authority and the Ethics Committee can only view the data after it has been forwarded to them. Any form saved can be used as a template.
- Datenbestand (database)
The "Datenbestand" (database) option allows the sponsor to research their applications that are authorised by the competent authority (BfArM or PEI) and the Ethics Committee and provides support with the preparation of e.g. applications of change. The "Datenbestand" view of an application also includes functions to initiate a new form in order to modify the application (amendment, notification of termination etc). Using these functions, the data that were last authorised are copied into the new form.