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Terms and Conditions

Terms and conditions for online sales of OxMed International GmbH

1. These terms and conditions apply to orders from customers in the Web Shop, as well as to agreements arising therefrom between customers and OxMed International GmbH (hereinafter: OxMed).

2. Prior to the online sales contract, the text of these terms and conditions is offered to the customer as a download.

3. The offer includes a complete and as exact as possible description of the products offered. The description is sufficiently detailed for an adequate judgement by the customer. Obvious mistakes or clerical errors in the offer are not binding on OxMed.

4. Each offer contains clear information about the rights and obligations of the customer associated with the acceptance of the offer. This concerns in particular:

  • The price including VAT;
  • Delivery costs;
  • The form of the conclusion of the contract and which actions are required for this;
  • Whether, and if so, in what way, the return of goods can take place;
  • The terms of payment, delivery and execution of the contract;
  • The period within which the offer must be accepted or the period within which OxMed guarantees the price.

5. If the customer has accepted the offer online, OxMed immediately confirms the acceptance of the offer online. As long as the receipt of this acceptance of the offer has not been confirmed, the customer can revoke the contract.

6. OxMed takes necessary technical and organizational measures to ensure the security of electronic data transmission and guarantees a secure web environment.

7. In case of electronic payment, OxMed will also take necessary security measures.

8. OxMed will add the following information to the product for the benefit of the customer, insofar as this information was not already made available at the time of entering into this contract:

  • The visiting address of the place where OxMed is located and where the customer can submit complaints;
  • The conditions under which the customer can have a return of the product take place and how the return must be made or corresponding information if this is not possible;
  • Information regarding warranties and existing post-purchase services;
  • The information included in paragraph 4 of these terms and conditions, insofar OxMed has not already made it available to the customer before the execution of the contract.

9. During a period of 14 (fourteen) days after receipt of the product (cooling-off period), the customer has the right to return the product without stating reasons and thereby withdraw from the contract.

10. During the cooling-off period, the customer must handle the product and the packaging with care. The customer will return the product to OxMed in its original condition, unworn and undamaged condition.

11. The cost of returning the product are borne by OxMed.

12. OxMed will refund the purchase price to the customer as soon as possible, but no later than 14 (fourteen) days after receipt of the return shipment.

13. OxMed guarantees that the product has the properties that the customer appropriately expect from it (which is stated in the accompanying instruction for use and / or the product brochure). OxMed grants a 6 (six) month warranty against manufacturing defects; whether there is a manufacturing defect is at the sole discretion of OxMed.

14. Amounts to be paid are immediately due and payable upon conclusion of the contract.

15. Payment must be made using the options indicated in the web shop.

16. The contract between OxMed and the customer, to which these terms and conditions apply, is exclusively governed by German Law.

17. Place of jurisdiction is Emmerich am Rhein.

18. The place of performance of all obligations arising from the contractual relationship is Emmerich am Rhein.

As a result of the MDR 2017/745 regarding medical devices the following paragraphs have been added:

19. The customer will not re-pack or re-label any of the OxMed products into different pack configurations, make any changes to OxMed’s instructions for use or modify OxMed’s products in any way without prior agreement with OxMed in writing.

20. Changes to pack configuration or translation of instructions for use or other information already supplied by OxMed or provision of further information which is necessary to market the device in a relevant territory will not be considered as modifications, but must still be agreed with OxMed in writing.

21. In accordance with MDR 2017/745 Article 16 any modifications to devices, that could affect the compliance of a device with MDR 2017/745, or other relevant standards will result in the regulatory obligations of the devices passing to the customer. If the customer supplies the OxMed products to a third party for the purposes of further distribution or sale, any modifications that are carried out by this party are the responsibility of the customer providing the products.

22. It is to be acknowledged by any customer who does wish to make changes as noted in the paragraphs 20 and 21 and who has agreed this in writing with OxMed that they will comply with the following points:

a). to have a registered quality management system in place that has been certified by a Notified Body who has been designated to certify the type of devices concerned;

b). to hold valid certificiation to ISO 13485 for Class 1 or Class 1 sterile medical devices;

c). to have, at least, a procedure within their certified quality management system that includes the undertaking to complete any corrective action required by OxMed in relation to the device in question in order to respond to safety issues or to ensure conformity with the MDR;

d). to undertake to repack devices in conditions that will not in any way affect the integrity of the devices and to ensure the pack is produced in the same neat and tidy condition as it was received from the manufacturer ensuring there will be no damage to the devices. Sterile products must not be re-packed;

e). to ensure the correct UDI (Unique Device Identifier) barcoding for any changed instructions for use or pack configuration and registration under the name of the customer;

f). to make an indication on the device, its packaging or information that accompanies the device stating details of any and all changes / modifications that have been made by the customer and showing their full registered trade name, registered place of business and an address where they can be contacted;

g). at least 28 days prior to making the modified products, as described in the paragraphs 20 and 21, available on the market, the customer must inform OxMed and the customer’s relevant Competent Authority of this intention. The customer may be requested by either party to provide mock-ups of the relabelled or repackaged device including any translated label or instruction for use. Within the same 28 day period the customer will submit to the applicable Competent Authority a certificate issued by a recognised Notified Body designated for the type of devices concerned, attesting that the quality management system of the customer complies with the requirements detailed in paragraph 22.

23. For all devices purchased from OxMed, the customer is responsible for ensuring: that pack labelling and instructions for use are correct for each device; that the label carries the CE mark and Notified Body number where applicable; that they receive and hold on file the Declaration (s) of Conformity for the devices they purchase from OxMed; that OxMed has assigned the UDI (Unique Device Identifier); that they will ensure that devices under their responsibility comply with storage and transport conditions set by OxMed.

 24. OxMed undertakes to have as part of their ISO 13485 system a process to ensure that they always keep the customer updated with their current ISO and regulatory certification and Declarations of Conformity and to inform the customer of any label and instructions for use changes.

 25. The customer agrees to inform OxMed of all Post Market Surveillance information that they may gather or received knowledge of, regarding the OxMed products and communicate this to OxMed within 30 (thirty) days.

26. The customer agrees to support OxMed in assisting with proactively collecting data for Post Market Surveillance purposes and will comply with the following:

  • When requested by OxMed the customer shall support proactive post market surveillance activities that OxMed is required to carry out as required by MDR 2017/745.
  • OxMed will not make unreasonable requests relating to this support and will agree the terms of involvement with the customer in writing prior to any such activities being requested.
  • The customer shall not refuse reasonable requests to participate in or support post market surveillance activities in the manner requested by OxMed.
  • Should the customer not reasonably be able to comply with the request for support at that time, they agree to inform OxMed, in writing, of the reason(s) without delay.
  • It is anticipated that, in most cases, post market surveillance activities will involve the customer collecting data from its customers by means of a questionnaire provided by OxMed and returning the responses to OxMed in a timely manner.
  • It is not anticipated that the frequency of these requests will be more than every 3 (three) years.

 27. The customer agrees to immediately inform OxMed of any information gained about vigilance issues/adverse incidents (reference MDR 2017/745 and current vigilance regulatory guidance documents) involving any of the OxMed products or any notifications received about similar products on the market that the customer might be informed of.

28. The customer agrees to report all vigilance issues of which they are informed about the OxMed products to the Competent Authority in the country where the products have been sold. (Reference MDR 2017/745 and current vigilance regulatory guidance documents).

29. Should a product recall become necessary, the customer agrees to assist OxMed in every way in retrieving all products that may be affected by the recall and recording all activities in this regard as required by OxMed. The customer will further agree to abide by the timescales requested by OxMed.

30. The customer agrees  to send back to OxMed all complaints from its customers immediately they are informed of them and will ensure that product samples of the complaint are obtained from the customer and sent back to OxMed for full investigation within 10 (ten) days of receipt of the complaint. 

31. Should any information about product distribution be required by OxMed’s Notified Body or by any Competent Authority, the customer agrees to supply it on request. 

32. The customer will maintain a 10 (ten) year record retention policy of all documents relating to the OxMed products. 

33. The customer will not use any product claims for OxMed products other than those stated on the supplied product information (prescription / operating instruction and any product brochure).

34. The customer will ensure that it conforms to all legislation, rules, regulations, and statutory requirements that exist within their territory.

Thank you for your order!