Provisions with respect to Regulation (EU) 2017/745 on medical devices

In addition to point 8 in our General Terms and Conditions: Conclusion of contracts with medical supply retailers, doctors, hospitals and other companies, the duties and responsibilities between manufacturer and retailer are regulated as follows:

  1. Role of the Supplier and the Customer
    Within the scope of these Terms and Conditions of Delivery, the Supplier adopts the position of manufacturer in accordance with Art. 2, No. 30 of Regulation (EU) 2017/745 and the Customer adopts the position of distributor in accordance with Art. 2, No. 34 of Regulation (EU) 2017/745.
  2. Distributor’s obligations
    The Customer undertakes to comply with the obligations imposed on it as a distributor in accordance with Art. 14 Regulation (EU) 2017/745.
  3. Traceability
    The Customer and the Supplier shall work together to guarantee the traceability of the goods.The Customer undertakes to ensure that it is able to provide information to the responsible authorities at all times about who provided the goods and/or to whom it sent the goods after it has handed over the last goods for a period of ten (10) years in accordance with Art. 25, Para. 2 Regulation (EU) 2017/745. In this respect, the Customer undertakes to set up a suitable procedure for this provision of information and shall document the procedure in accordance with point 7.5.9 ISO 13485:2016.The Customer undertakes to hand over the suitable documentation for the provision of information to the Supplier after the ten (10) years mentioned have elapsed or to dispose of it properly following a written request from the Supplier.The Customer undertakes to comply with the obligations regulated in 3. even if business operations cease before the ten (10) years mentioned have elapsed or if insolvency proceedings are initiated against it.
  4. Acceptance and Documentation of Experiences, Findings and Other Information about the Goods
    The Customer undertakes to document all experiences and findings about the goods, including trends to be observed and all incoming complaints or reports about suspected incidents in connection with the goods and store this documentation for a period of ten (10) years. In this respect, the Customer undertakes to establish a suitable procedure for the acceptance of such experiences, findings, complaints or reports about the goods, and their documentation and keep this documentation up to date.The Customer undertakes to hand over documentation regarding experiences and findings about the goods, including trends to be observed and incoming complaints or reports to the Supplier after the ten (10) years mentioned have elapsed or to dispose of it properly following a written request from the Supplier.The Customer also undertakes to comply with the obligations regulated in 4. even if business operations cease before the ten (10) years mentioned have elapsed or if insolvency proceedings are initiated against it.
  5. Forwarding of Experiences, Findings and Other Information to the Supplier
    The Customer undertakes to forward all experiences and findings about the goods, including trends to be observed and all incoming complaints or reports about suspected incidents in connection with the goods to the Supplier without delay or to forward it to a person specified by the Supplier. The forwarding is to be carried out in writing to OPED GmbH, Medizinpark 1, 83626 Valley/Oberlaindern, Germany. In the case of suspected serious incidents in accordance with Art. 2, No. 64 Regulation (EU) 2017/745, information shall be passed on in advance by telephone +49 (0)8024 60818 – 210, fax +49 (0)8024 60818 – 299, or e-mail mail@oped.de.
  6. Advertising
    The Supplier shall make all materials for the advertising of the goods (e.g. texts, names, trademarks, illustrations and other symbols) available to the Customer if the Customer is performing the advertising of the goods. The Customer undertakes to exclusively use the materials provided by the Supplier for advertising the goods.

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