These rules apply to every company that applies to, or supplies, Optinovate Technologies ("Optinovate", Rotterdam, the Netherlands). By accepting them you confirm that your company will follow them. Optinovate imports and distributes medical devices in the European Union and must be able to rely on what its suppliers promise.
1. Who may supply
- You are the legal manufacturer of the products, or you are authorised by the manufacturer to sell them in the European Union. On request you show the authorisation.
- The company details, contacts and bank details you give are true and complete. You inform us of any change.
- You tell us which exclusive dealers or distributors you have in Europe, and for which countries. You confirm that supplying Optinovate for the countries you list does not breach an agreement you have with anyone else, and you tell us at once when that changes.
2. Product information
- Descriptions, specifications, photos, prices and documents you submit are correct, complete and up to date. No false or unproven claims (for example about performance, certificates or approvals).
- You own the photos and texts you submit, or may pass them on. Optinovate may use them in its shop, catalogue and marketing.
- You tell us before you change a product (design, parts, materials, software, labelling, manufacturer or factory).
3. EU medical device rules (MDR 2017/745)
- Medical devices carry a valid CE marking under the EU MDR. You provide the EU Declaration of Conformity and, where required (class Is, Im, Ir, IIa and higher), the valid notified body certificate.
- Manufacturers outside the EU name an EU authorised representative. Manufacturer and devices are registered in EUDAMED where required, with a UDI on the label.
- Labels and instructions for use meet the MDR. Instructions for use are available in the language(s) of each country where we sell the product (for example Dutch for the Netherlands and Belgium).
- You inform us within 5 working days when a certificate expires, is suspended or withdrawn, or when a document changes, and you upload the new document in the portal.
4. Incidents, complaints and recalls
- You inform us immediately, and at the latest within 2 working days, of any serious incident, field safety corrective action (FSCA), field safety notice or recall that concerns products supplied to us.
- You help us handle complaints from our customers and answer our questions within 5 working days.
- You record serial or lot numbers so that every device can be traced, and state them on the packing list.
5. Other EU product rules
- Products meet all EU rules that apply to them, such as RoHS, REACH, the Low Voltage and EMC rules for electrical equipment, and the rules for batteries and packaging.
- You provide the product weight, packaging weight and battery details we need for WEEE and battery reporting.
6. Prices
- Prices to Optinovate are excl. VAT and include the delivery term (Incoterm) you state. Quoted prices stay valid for at least 90 days.
- You announce price changes in writing at least 60 days in advance. Orders placed before the change keep the old price.
- Optinovate sets its own selling prices. A recommended retail price is only a recommendation.
7. Orders and delivery
- You confirm each purchase order within 2 working days, with the delivery date.
- You deliver on the agreed date and delivery term, send the tracking number on dispatch, and inform us at once of any delay.
- Each shipment has a commercial invoice and packing list with our purchase order number, the HS code, country of origin, serial or lot numbers and, for shipments from outside the EU, everything needed for customs.
8. Packing, labels and shipping
- Every unit carries the Optinovate importer label before it leaves your premises. Print it from the portal ("Importer labels"), one per unit with its serial number, and stick it on the device's own packaging. It must not cover the CE marking, the UDI, the manufacturer's label or any warning.
- Instructions for use in the languages required for the destination country (for example Dutch for the Netherlands and Belgium) are in the box.
- Products are new, unused, complete, in the manufacturer's original packaging, and exactly as the sample we approved.
- Outer packing is export-proof: strong cartons, moving parts and optics fixed, protection against moisture and shocks. Wooden pallets and crates are heat-treated (ISPM 15).
- Each carton is marked with our purchase order number, the product and quantity, the serial numbers, gross weight and "Optinovate Technologies".
- Before dispatch you upload pre-shipment photos in the portal: the product, the importer label on the packaging, the serial number plate and the packed cartons. We may ask you to hold the shipment until we have seen them.
- Shipments for our customers (drop-shipping) carry no prices, invoices or advertising of your company, only our documents.
9. Quality control and non-conforming goods
- We inspect every delivery within 10 working days of arrival. A product is non-conforming when it is wrong, used, damaged, incomplete, counterfeit, not as the approved sample or the product information, or when the importer label, instructions for use or required documents are missing.
- For non-conforming goods you replace them or refund them in full, within 30 days, at your cost, including freight, duties and return shipping. If we relabel, repack or repair them ourselves, we charge the cost to you.
- A new product is listed only after we have approved a sample. Later deliveries must match that sample.
- After a non-conforming delivery we may require an inspection before shipment (by us or an inspection company) at your cost.
- Counterfeit or unsafe products end the cooperation at once and are reported to the authorities.
10. Warranty, service and returns
- You give at least 12 months' warranty from delivery to the end customer, unless we agreed a longer period in writing.
- Products that are defective on arrival or within the warranty are repaired or replaced at your cost, including transport.
- Spare parts and service remain available for at least 5 years after we last bought the product.
11. Confidentiality and customers
- Prices, order details, customer information and anything else you learn about Optinovate's business stay confidential.
- You do not approach customers you learned about through Optinovate to sell to them directly.
- Personal data is handled according to the GDPR.
12. Honest business
- No bribery, no forced or child labour, and compliance with EU and international sanctions and export rules.
13. Listing
- Optinovate decides which products it lists, how, and at what price, and may stop listing a product or supplier at any time. A listing is not an order and gives no exclusivity, unless agreed in writing.
- The portal account is for your company only. Keep your password safe.
14. Changes and law
- Optinovate may change these rules. The new version is shown in the portal and must be accepted before you continue.
- Dutch law applies. Disputes go to the competent court in Rotterdam, the Netherlands.
