AEO
Since 2013 PROTEC is “Authorized Economic Operator – AEO Type C”. The quality seal confirms that PROTEC occupies the position of a secure, reliable and trustworthy business partner inside the global movement of goods. Behind the creation of the AEO hides a security concept, which aims to certify all international companies participating safely in the cross-border movement of goods. The Secure Supply Chain from manufacturer to end customer should be ensured in this way.
CE
All PROTEC medical devices are CE marked. The CE marking on PROTEC´s medical devices indicates that the products comply with the essential requirements for safety of medical devices according to the EU medical device regulation (MDR 2017/745). For products that still have an MDD certificate (Medical Devices Directive – MDD 93/42/EEC), this certificate is still valid until December 31, 2028. For formal and legal reasons, the validity periods specified on the MDD certificates will no longer be extended. Therefore, when importing a product from the European Union, it may appear that a certificate has already expired, although its legal validity continues. Further information is available at: Updated – Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices (europa.eu)
CE marking on PROTEC´s NDT products indicates that products correspond to EU directives Richtlinien 2006/42/EG, 2014/30/EU und 2014/35/EU. The CE marking was primarily created to ensure safe and reliable products within the European Economic Area.
EN ISO 13485
ISO 9001
PROTEC has introduced a quality management system, which completely fulfills the requirements of the international standards EN ISO 13485 and ISO 9001. PROTEC’s quality management system is certified through the notified body DQS MED. Issued certificates from DQS MED confirm the compliance with the standards and the integrity of the quality management system. For our class IIb medical devices we use DQS MED as a notified body (identification number 0297).
Verkehrsfähigkeit
The Certificate of Marketability according to §10 Medical Devices Implementation Act confirms that all listed PROTEC products are fully marketable in Germany, in the member states of the European Union and in other parties to the agreement on the European Economic Area.
Ermächtigter Ausführer
PROTEC is approved exporter. An approved exporter is authorized to show a declaration of origin in the customs invoice without considering any minimum amount. The declaration of origin in the invoice contains the authorization number of the exhibitor.
