Coronavirus/COVID-19

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.

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

Many answers to regulatory questions can be found at Coronavirus SARS-CoV-2 (in German language).

We also publish a list of tests that were firstly placed on the German market and registered according to § 25 MPG (German Medical Devices Law): Corona-Tests (in German language).
In addition, BfArM provides a list of antigen tests for direct pathogen detection based on the German regulation "Coronavirus-Testverordnung – TestV".

Medical Devices Information System

Extensive information is required for the market surveillance of medical devices in Germany. BfArM has set up an information system for medical devices according to § 33 Medical Devices Act (MPG), which enables internet-based data entry and editing by persons reporting, sponsors and the competent authorities.

The manuals for persons reporting and sponsors (in German) are publicly available on our site.

The manuals for competent institutions are available within the Medical Devices Information System, where other documents such as the training materials are also uploaded. For this you need to be logged in with your username and password.

General Information Medical Devices Information System

Please note, that the entire Medical Devices Information System is in German language.
The following information gives you an overview of the system's structure and operating controls.

Notifications of Medical Devices and In Vitro Diagnostics

The first placing on the market of MD and IVD as well as information regarding the safety officer must be notified with the Medical Devices Information System.

Clinical Investigations and Performance Evaluations

Starting from March 21, 2010, CI and PE must be approved by the competent authority (BfArM or PEI) and approvingly evaluated by an Ethics Committee before they may commence. The application forms for this purpose can be submitted online through the Medical Devices Information System.

Notification on Incidents and SAE with Medical Devices

Incidents and serious adverse events (SAE) in clinical trials with medical devices must be notified with the BfArM and/or the PEI according to MPSV Directive. An incident is a malfunction, failure or a modification of the features or performance or an inaccurate label or instruction manual for a medical device, which directly or indirectly caused, may have caused in the past, or may cause in the future, death or a serious aggravation of the state of health of a patient, a user or another person (MPSV § 2 (1)).

According to the directive of the Ordinance on Medical Devices Vigilance (Medizinprodukte-Sicherheitsplanverordnung, MPSV), those responsible for the first placing on the market of medical devices are obligated to report incidents that occur in Germany as well as product recalls taking place in Germany to the Federal Institute for Drugs and Medical Devices (BfArM) and/or to the Paul-Ehrlich-Institute (PEI) according to its jurisdiction.

Sponsors and investigators are required to report serious adverse events (SAE) in clinical trials or performance evaluations to the competent authority (BfArM or PEI), according to § 3 (5) of the Ordinance on Medical Devices Vigilance (MPSV).

The report forms recommended in the "Bekanntmachung zur Sicherheitsplanverordnung (MPSV)" must be used to report incidents and serious adverse events (SAE) in clinical trials.

Certificates for Medical Devices

The notified bodies certify the manufacturers that a medical device conforms to both the EU and German legal requirements. Since January 1st 2004, the German notified bodies enter the notifications on issued, restricted, suspended, withdrawn or refused certificates (according to § 18 Medical Devices Act, MPG) in the Medical Devices Information System.

The content of the certificates database is based on Annex 3 of the DIMDI-Verordnung. Only the competent notified bodies and competent authorities currently have access to this database.

The addresses, identification numbers and scope of the notified bodies in Germany and the EEA member countries as well as the notifying authorities can be found under:

Classification and Demarcation of Medical Devices

Medical devices other than In vitro diagnostics and active implantable medical devices are classified. The classification is based on the classification rules in Appendix IX of Directive 93/42/EEC. In vitro diagnostics are assigned according to a list from Appendix II of Directive 98/79/EC, or are devices for self-testing or other devices.

When there are differences of opinion between the manufacturer and the notified body, the competent authority decides on the classification of medical devices or the assignment of an IVD. BfArM is responsible for decisions on the classification of medical devices (according to § 13 Medical Devices Act, MPG) while PEI is responsible for certain In vitro diagnostics.

The competent authorities enter the notifications in the Medical Devices Information System for the classification of medical devices or demarcation as non-medical devices. The contents of the MD classification/demarcation database are based on Annex 5 of the DIMDI-Verordnung. Only the competent authorities currently have access to this database.

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