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Hello,
Can someone advise on the following. If a manufacturer of class III device (a sterile prefilled syringe, device, not pharmaceutical), CE-marked, supplies it in EU market with a needle which is intended for the administration (added in the box with a prefilled syringe for doctor's convenience), will that manufacturer be also considered a procedure pack producer? Needles are also CE-marked by own manufacturer, and packaged in the original sterile packaging without any modifications. Info about both manufacturers and their EC-REP appears on the labeling, instructions for use explains how to use syringe and needle, compatibility with a needle is ensured by test reports etc. So does this manufacturer need to issue a "statement" according to Article 22 (2). Will that require to create 2 SRN on EUDAMED, as a manufacturer and procedure pack (but it is actually the same final product, with same labeling and UDI)?