responsibility finder
Schleswig-Holstein

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

Source: Zuständigkeitsfinder Schleswig-Holstein (Linie6PLus)

Service Description

Manufacturers of in-vitro diagnostics can apply for the issue of a certificate of free sale for export purposes. The certificate of free sale confirms that the manufacturer is established in Germany and that the product can be traded within the EU.

Are you responsible for placing an in vitro diagnostic medical device on the market in accordance with Article 5 and Article 10 of Regulation (EU) 2017/746 and would like to export it outside the Union? Then the relevant competent authority will issue a certificate in accordance with Section 10 MPDG at your request.

This certificate certifies that the product may be traded in the Union.


Process flow
  1. You submit your application
  2. The competent authority checks the documents
  3. The competent authority requests additional documents if necessary
  4. The competent authority issues the certificate
Who should I contact?

State Office for Social Services of the State of Schleswig-Holstein

Requirements
  • Product must be placed on the market in accordance with Article 5 Article 10 of Regulation (EU) 2017/746 of an in vitro diagnostic medical device
  • Only manufacturers and authorized representatives based in Germany can submit an application for a certificate of free sale for in vitro diagnostic medical devices here
Which documents are required?
  • Declaration of conformity
  • Certificate(s) of the Notified Body(ies)
  • Product list
What are the fees?

Cost type: variable

Description of costs: Fee

Note: Medical device law is federal law and enforcement is the responsibility of the respective federal states. Therefore, the respective cost or fee regulations of the federal state must be applied.

What deadlines do I have to pay attention to?

Note: The certificate of marketability according to § 10 MPDG does not contain any time limits. It confirms the status as of the date of issue. Each recipient country decides on the period of validity of the certificate itself.

Processing duration

Duration: 1 week to 3 weeks

In Schleswig-Holstein, processing times of up to 6 weeks may occur in exceptional cases.

Legal basis
Appeal

Objection under the VwVfG against the rejection of an application and the charging of fees

What else should I know?

In Schleswig-Holstein, no distinction is made between active and non-active medical devices as well as active and non-active in vitro diagnostic medical devices.

Author

The text was automatically translated based on the German content.

Technically approved by

Hessian Ministry for Social Affairs and Integration (HMSI)

Professionally released on

08.02.2023

Teaser

Manufacturers of in-vitro diagnostics can apply for the issue of a certificate of free sale for export purposes. The certificate of free sale confirms that the manufacturer is established in Germany and that the product can be traded within the EU.

Process flow

  1. You submit your application
  2. The competent authority checks the documents
  3. The competent authority requests additional documents if necessary
  4. The competent authority issues the certificate

Who should I contact?

State Office for Social Services of the State of Schleswig-Holstein

Requirements

  • Product must be placed on the market in accordance with Article 5 Article 10 of Regulation (EU) 2017/746 of an in vitro diagnostic medical device
  • Only manufacturers and authorized representatives based in Germany can submit an application for a certificate of free sale for in vitro diagnostic medical devices here

Which documents are required?

  • Declaration of conformity
  • Certificate(s) of the Notified Body(ies)
  • Product list

What are the fees?

Cost type: variable

Description of costs: Fee

Note: Medical device law is federal law and enforcement is the responsibility of the respective federal states. Therefore, the respective cost or fee regulations of the federal state must be applied.

What deadlines do I have to pay attention to?

Note: The certificate of marketability according to § 10 MPDG does not contain any time limits. It confirms the status as of the date of issue. Each recipient country decides on the period of validity of the certificate itself.

Processing duration

Duration: 1 week to 3 weeks

In Schleswig-Holstein, processing times of up to 6 weeks may occur in exceptional cases.

Legal basis

Appeal

Objection under the VwVfG against the rejection of an application and the charging of fees

What else should I know?

In Schleswig-Holstein, no distinction is made between active and non-active medical devices as well as active and non-active in vitro diagnostic medical devices.

Author

The text was automatically translated based on the German content.

Technically approved by

Hessian Ministry for Social Affairs and Integration (HMSI)

Professionally released on

08.02.2023

Further information and offers