Important communication in order to ensure compliance with the legal requirements of medical devices
Our Company is a distributor of medical devices. We inform you that the new Regulation on medical devices, MDR 2017/745, has come into force in Europe, which has definitively replaced Directive 93/42 / EEC starting from 26 May 2021. In particular, the new MDR 2017/745 strengthens the obligations which must be fulfilled not only by economic operators (manufacturer, authorized representative, importer and distributor), but also by health professionals and users of devices. Therefore, in application of the above legal requirements and as our CUSTOMER / DISTRIBUTOR, we ask for your cooperation to allow us to guarantee the traceability of our devices, as well as your support in the after-sales surveillance and surveillance action. Specifically, we ask you to express your consent to apply and maintain the following provisions:
✓ TRACEABILITY, ensuring appropriate methods (registers or other) in the management of our products with reference to codes and lots, quantities and, in the case of further distribution, associate these data with the final recipients.
✓ AFTER-SALES SURVEILLANCE, by sending to our Quality Department or Sales Department any non-conformities you have found on our. devices, as well as complaints or other information by users, regarding the product itself, its packaging or labeling. In the event of Non-Conformity or Complaints, we ask that these be promptly communicated to us, with the indication of the data necessary for the identification of the products (code, lot, delivery date). If possible, we also ask you to send us a sample of the products found to be defective and, in any case, to cooperate with our offices for the adoption of corrective actions, withdrawal or recall, if necessary.
✓ STORAGE OF PRODUCTS, respecting the storage conditions indicated on the packaging, or keeping the products in a clean and dry place, away from direct heat sources, away from atmospheric conditions, in order not to compromise their quality. The document is tacitly accepted from the date of receipt.