T
Thukira
Hi.. I'm completely new IVD, can someone help me out with Technical File Template for IVD - self declaration please
Hi chris
I feel "Class A" will apply as per definition as the device is laboratory equipment intended for in-vitro diagnosis where there wont be any patient contact with equipment, only the sample will be taken from patient for analysis using this device.
Rule 5 The following devices are classified as class A:
a) products for general laboratory use, accessories which possess no critical characteristics, buffer solutions, washing solutions, and general culture media and histological stains, intended by the manufacturer to make them suitable for [FONT=EUAlbertina,EU Albertina][FONT=EUAlbertina,EU Albertina]in vitro [/FONT][/FONT]diagnostic procedures relating to a specific examination;
(b) instruments intended by the manufacturer specifically to be used for [FONT=EUAlbertina,EU Albertina][FONT=EUAlbertina,EU Albertina]in vitro [/FONT][/FONT]diagnostic procedures;
(c) specimen receptacles.