Freiverkaufszertifikate für Exportzwecke von Medizinprodukten Ausstellung Für Medizinprodukte exkl. In-Vitro-Diagnostika - aktiv
Nordrhein-Westfalen
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99050178012001, 99050178012001
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Typ 3
Inhalt
Certificates of free sale for export purposes of medical devices Exhibition For medical devices excl. in-vitro diagnostics - active
Begriffe im Kontext
nicht vorhanden
- Feststellung der geltenden Normen, technischen Spezifikationen und Zertifizierung der Produkte
Fachlich freigegeben am
02.11.2023
Fachlich freigegeben durch
Ministry of Labor, Health and Social Affairs of the State of North Rhine-Westphalia
Medical Device Law Implementation Act (MPDG)
Article 60 Medical Device Regulation (MDR) - Regulation (EU) 2017/745
REGULATION (EU) 2017/745 Article 11 for EU authorized representatives
As a manufacturer of medical devices or its authorized representative, you can apply for the issue of a certificate of free sale for export purposes. The certificate of free sale confirms that the manufacturer or authorized representative has its registered place of business in Germany and that the product in question can be traded within the Union.
Are you responsible for placing a medical device on the market in accordance with Article 5 and Article 10 of Regulation (EU) 2017/745 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.
- Declaration of conformity
- Certificate(s) of the Notified Body(ies)
- Product list
- Product must be placed on the market in accordance with Article 5 and Article 10 of Regulation (EU) 2017/745 of a medical device
- Only manufacturers and authorized representatives based in Germany can submit an application for a certificate of free sale for medical devices here
The costs are based on the General Administrative Fee Regulations for the State of North Rhine-Westphalia (Allgemeine Verwaltungsgebührenordnung NRW - AVwGebO NRW).
Tariff item 12.1.6.2.9
- You submit your application
- The competent authority checks the documents
- The competent authority requests additional documents if necessary
- The competent authority issues the certificate
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.
Objection under the VwVfG against the rejection of an application and the charging of fees
- Certificates of free sale for export purposes of medical devices Exhibition For medical devices excl. in vitro diagnostics - active
- Certificates of free sale are issued exclusively for medical devices and in-vitro diagnostics.
- A certificate of free sale 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.
- CE-marked medical devices and in-vitro diagnostics can be marketed within the EU and the associated contracting states without official confirmation. This means that no certificate of free sale is issued.
- Fee-based service