KL 26_ 494 Potrošni materijal za elektrofiziologiju srca

The contract duration is 24 months. The contract begins from the date of mutual signature by both parties.

• EOJN RH (Elektronički oglasnik javne nabave Republike Hrvatske) for electronic submission of offers and communication.
• eESPD obrazac (European Single Procurement Document form) must be completed.
• Compliance with Tehnička specifikacija/Troškovnik (Technical Specification/Cost Estimate) for offered products.
• Proof of technical and professional capability, including human and technical resources and experience from previous relevant projects.
• Submission of catalogs, brochures, descriptions, or photos, or other technical documentation for product compliance.
• Certificates of authenticity for products, if required by the tender.
• Compliance with Regulation (EU) 2017/745, Regulation (EU) 2017/746, or the Law on Medical Devices (NN 76/13) for medical devices.
• Valid certificate of conformity issued by a notified body for medical devices.
• For non-EU medical device manufacturers, the declaration of conformity must include the authorized representative's details in the EU.
• Valid permit for wholesale of medical devices according to the Law on Medical Devices (NN 76/13) or equivalent for EU companies.
• Offers and documentation must be in Croatian language and Latin script, with provisions for foreign terms and requests for certified translations if ambiguity arises.