Amendment of the Croatian market notification
Where documentation filed with the initial notification of placing a device on the market changes, HALMED requires a notification of amendment referring to the last classification reference of the Agency's receipt certificate (530-09/...), stating clearly what changed and enclosing the relevant notification form, the new product list where it changed, the proof of payment, and any other document depending on the change. HALMED notes by way of example that a change of the manufacturer's address automatically triggers a change of the labelling, instructions for use, declaration of conformity and conformity certificate.
- The amendment procedure is cited by HALMED against Article 42(3) of the Zakon o medicinskim proizvodima (NN 76/13), i.e. the legacy national provision, and is charged per the price list (change of an entry in the register of medical devices 300,00 EUR, or 200,00 EUR where the entry decision is unchanged).
- Changes requiring a new or amended EU certificate must be assessed by the notified body before the national amendment is filed.
Croatian (source language). Verbatim: "U slučaju izmjene dokumentacije koja je priložena prilikom inicijalne obavijesti o stavljanju u promet medicinskih proizvoda, sukladno s čl. 42. (3) Zakona o medicinskim proizvodima (Narodne novine, br. 76/13.), potrebno je poslati obavijest o izmjeni s pozivom na posljednju klasifikacijsku oznaku (530-09/…) potvrde Agencije te jasno navesti što se izmijenilo".