Medical Devices Information System

Extensive information is required for the market surveillance of medical devices in Germany. DIMDI 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.

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. more »

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. more »

Certificates

The notified bodies certify that a medical device conforms to both the EU and German legal requirements. The notified bodies collect the notifications concerning the certificates in the Medical Devices Information System. more »

Classification

When there are differences of opinion, the competent authority (BfArM or PEI) decides on the classification of medical devices and enters the notifications in the Medical Devices Information System. more »

Incidents and SAE

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. more »