Certifying free sale certificates for medical devices

Your company wants to export medical devices outside the EU? Then you need to apply for a certificate.

Companies that want to export medical devices to countries outside the European Union require an official certificate.

Required documents:

  • CE certificate about the product
  • Quality assurance certificate (except for Class I products = low-risk products)

The application is made informally.

Preconditions

The products to be exported must be active non-implantable medical devices (= dependent on a power source or other energy source) or an In-Vito diagnostic (= products intended for analysis of samples from the human body) and must be subject to medical device law.

Hints

All medical devices must be displayed in advance in the Database of the BfArM (in DIMDI).

§ 34 Abs. 1 of the Medical Devices Act (MPG) (still valid until 25.05.2022)

Related Links

  • Article 60 Regulation (EU) 2017/745
  • Article 16(1a) of Regulation (EU) 2017/745
  • Article 22 Regulation (EU) 2017/745
  • Article 120(3) and (4) of Regulation (EU) 2017/745
  • § 10 Medical Device Law - Implementing Act (MPDG)

You submit an application and receive the export certificate if your submitted documents are checked positively.

  1. Submit application
  2. Authority examines the documents
  3. Authority may request documents for
  4. Authority issues the certificate

Responsible for the content
MWG

Last update or date of publication
04.11.2021