Dear All,
Now our Company is develop the urine analyzer - Is there a special standard applicable for Urine Analyzer besides the IVD standard (98-79-EEC)?
Thanks very much for your warmly replay
Hi
Welcome to the Cove!!
I would like to correct you that
IVDD 98/79/EEC is not a standard, it’s a regulation (Directive). Apart from said directive, I request you to go through the applicable European Commission guidelines (
MEDDEV). This guidelines aim at promoting a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the aforesaid Directive, and by the Competent Authorities charged with safeguarding Public Health.
To download the guidelines, please refer below
European commission website
Please be patient, someone will help you as regards to product (Urine Analyzer) specific standards (list of applicable standards)
Regards
S.Subramaniam