Hello,
Is it possible for manufacturers to obtain CE Certificate with ISO 15197:2013 as the standard rather than 2003 right now? I know that the 2013 standard is not mandatory, but I want to know if it is possible to get a blood glucose meter certified using the 2013 standard.
Thank you.
Is it possible for manufacturers to obtain CE Certificate with ISO 15197:2013 as the standard rather than 2003 right now? I know that the 2013 standard is not mandatory, but I want to know if it is possible to get a blood glucose meter certified using the 2013 standard.
Thank you.
Please remember that in general application of harmonized standards is not mandatory.
Cheers,
Ronen.