Applying for certificates of free sale for non-active in-vitro diagnostics

1. You submit your application.
2. The competent authority checks the documents.
3. The competent authority requests additional documents if necessary.
4. If all requirements are met, the competent authority issues the certificate of free sale.

Please contact the Landesamt für Soziales, Jugend und Versorgung (LSJV) - Abteilung 5 - Referat 54 - Medizinprodukte.

• Your establishment is located in the area of responsibility of the relevant authority and you are registered in Eudamed.
• Your medical devices concerned are registered in DMIDS.
• There are no known concerns on the part of the authority.
• Current documentation of the medical devices concerned is available.
• It is a non-active in-vitro diagnostic device.

• Declaration of conformity of the medical device concerned
• Certificate(s) of the Notified Body(ies) of the medical device concerned
• Certification of the manufacturer's quality management by a notified body
• Product list in accordance with the IVDR

There are no deadlines for the application.

The duration of processing depends on the time required to check the products.

• Medical Devices Implementation Act (MPDG)
• In-vitro Diagnostics Regulation (IVDR) - Regulation (EU) 2017/746

Objection under the Administrative Procedure Act (VwvVfG) against the charging of fees

Forms available: No

Written form required: Yes

Informal application possible: Yes

Personal appearance necessary: No

Online services available: Yes

30.01.2023