Anzeige des gewerblichen Umgangs mit Medizinprodukten

If you

• place medical devices or in vitro diagnostic medical devices on the market for the first time,
• process medical devices that are used as intended to be low-germ or sterile exclusively for others,
• Assembling or sterilizing systems or dental units as well as medical devices

you must notify the competent authority of this.

• the appropriate information on reagents, medical devices with reagents and calibrators and control materials relating to common technological characteristics and analytes, and for other in vitro diagnostic medical devices;
• in the case of in vitro diagnostic medical devices listed in Annex II to Directive 98/79/EC and in vitro diagnostic medical devices for self-testing, all information enabling those in vitro diagnostic medical devices to be identified, the analytical and, where applicable, diagnostic performance data referred to in point 3 of Section A of Annex I to Directive 98/79/EC, the results of the performance evaluation and information on certificates;
• in the case of a "new in vitro diagnostic medical device" within the meaning of the word, an additional indication that it is a "new in vitro diagnostic medical device"

Fees may apply. Please contact the relevant authority.

The notification must be made before the start of the activity.

The responsibility lies with the Federal Institute for Drugs and Medical Devices.