Freiverkaufszertifikate für Exportzwecke von Medizinprodukten Ausstellung
Hamburg
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99050178012000
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Typ 3
Inhalt
<div lang="en-x-mtfrom-de">Free sale certificates for export purposes of medical devices issuance</div>
<div lang="en-x-mtfrom-de">Apply for free sale certificates for medical devices</div>
Begriffe im Kontext
<div lang="en-x-mtfrom-de">Export certificate</div> (Synonym), <div lang="en-x-mtfrom-de">certification</div> (Synonym), <div lang="en-x-mtfrom-de">MDR</div> (Synonym), <div lang="en-x-mtfrom-de">Export certificates for medical devices</div> (Synonym), <div lang="en-x-mtfrom-de">Marketability of medical devices</div> (Synonym), <div lang="en-x-mtfrom-de">Export of medical products</div> (Synonym), <div lang="en-x-mtfrom-de">FSC</div> (Synonym), <div lang="en-x-mtfrom-de">Free Sales Certificate</div> (Synonym), <div lang="en-x-mtfrom-de">Free Sale Certificate</div> (Synonym), <div lang="en-x-mtfrom-de">Certificate § 10 MPDG</div> (Synonym), <div lang="en-x-mtfrom-de">apostille</div> (Synonym), <div lang="en-x-mtfrom-de">legalization</div> (Synonym), <div lang="en-x-mtfrom-de">IVDR</div> (Synonym)
Fachlich freigegeben am
21.07.2023
Fachlich freigegeben durch
nicht vorhanden
As a manufacturer of medical devices and in-vitro diagnostics or its authorized representative, you can apply for the issuance of a free sale certificate for export purposes.
Are you responsible for placing a medical device on the market according to Article 5 and Article 10 of Regulation (EU) 2017/745 or Article 5 and Article 10 of Regulation (EU) 2017/746 of an in-vitro diagnostic device and would like to export it outside the Union? Then the competent authority will issue a certificate according to § 10 MPDG upon your application. This certificate certifies that the product can be traded in the Union.
- Declaration of Conformity(s)
- Certificate(s) from the notified body(s)
- product list
- The product must be placed on the market according to Article 5 and Article 10 of Regulation (EU) 2017/745 for a medical device or Article 5 and Article 10 of Regulation (EU) 2017/746 for an in-vitro diagnostic device
- Only manufacturers and authorized representatives based in Hamburg can apply for a free sale certificate for medical devices or in-vitro diagnostics here
Medical product law is federal law and is enforced under the sovereignty of the respective federal states. Therefore, the respective cost or fee schedule of the federal state must be applied. In the Free and Hanseatic City of Hamburg, this is the schedule of fees for public consumer protection.
- You submit your application
- The competent authority checks the documents
- The competent authority may request additional documents
- The competent authority issues the certificate
The certificate of marketability according to § 10 MPDG does not contain any limitations. It confirms the status as of the date of issue. Each recipient country decides for itself how long the certificate is valid.
Objection according to VwVfG against rejection of an application or the charging of fees
- Free sale certificates are only issued for medical devices and in-vitro diagnostics.
- A free sale certificate can only be applied for by the manufacturer or the European authorized representative based in the Federal Republic of Germany.
- The medical devices and in-vitro diagnostics applied for must meet the legal requirements and be CE marked.
- Within the EU and the associated contracting states, CE-marked medical products can be marketed without official confirmation. Ie no free sale certificate will be issued.
- Paid service