Free-sale certificates for medical products certify Unfortunately this specification of service has not yet been completely translated.

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

Required documents: CE certificate for the product Certificate of quality assurance (except for Class I products = low-risk products)


The application shall be made informally.

Preconditions
The products to be exported must be active medical devices (= energy-supplied medical devices) that are subject to medical device law.
You submit an application and, if your submitted documents are tested positive, you will receive the export certificate. Submit a request Authority examines the documents Authority may request documents Authority issues the certificate