Medizinprodukte: Gewerblichen Umgang anzeigen

Any person responsible within the meaning of § 5 sentences 1 and 2 of the Medical Devices Act (MPG) who is based in Germany and places medical devices on the market for the first time must notify the competent authority of this before commencing activities, stating his or her address.

Any person responsible within the meaning of Section 5 sentences 1 and 2 of the German Medical Devices Act (MPG) who is domiciled in Germany and places medical devices on the market for the first time must notify the competent authority, stating their address, before commencing their activities.

The first placing of medical devices on the German market requires notification to the competent authority. Notifications are made centrally via an internet-based registration system at the German Institute for Medical Documentation and Information.

Depending on the risk class of the product in question, the certificate of conformity of a notified body must be submitted.

No fees are charged for the processing of a proper, complete notification . For official actions in connection with the notification, which are carried out in the interest of or at the instigation of the fee debtor, the cost range is EUR 60 - 2,200.

• Notification to the competent authority via the DIMDI
• Plausibility check by the State Office for Health and Social Affairs (LAGuS), completion if necessary
• Release of the notification

Before placing on the market

At the request of a manufacturer or authorized representative, the competent authority for export issues a certificate of marketability of the medical device in Germany (Section 34 (1) of the Medical Devices Act).

• Anyone placing medical devices on the market for the first time must notify the competent authority, stating their address, before commencing their activities.
• The first placing of medical devices on the German market requires notification to the competent authority.
• Notifications are made centrally via an internet-based registration system at the German Institute for Medical Documentation and Information.

State Office for Health and Social Affairs (LAGuS) Mecklenburg-Western Pomerania