Apply for certificates of free sale for 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 State Office for the Environment (LfU) - Department 2 - Division 25.1.

• 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.

• Declaration of conformity of the medical device concerned
• Certificate(s) from 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.

• Medical Devices Implementation Act (MPDG)
• Medical Device Regulation (MDR) - Regulation (EU) 2017/745
• 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