Can a product be reviewed and CE Marked in accordance with ISO 15197:2013

[missjenny]

Hi everyone,

Can a product be reviewed and CE certified in accordance with ISO 15197:2013 rather than 2003 right now? My notified body is saying it is impossible as it has not been harmonized yet, but I hear rumors that some notified bodies are certifying blood glucose meters (BGMS) with the 2013 standard version.

Thank you.

 

[Ronen E]

Re: How to guess when the standard gets harmonised?

See here

You probably misinterpreted their statement. You can use whatever published standard you wish, or no published standard at all, in support of the ER being met; It's just that you will have to justify how your alternative methods are satisfying the ER (rather than rely on the "automatic" presumption of conformity conferred by following a harmonized standard).

 

[pkost]

If you were to seek approval using the 2013 standard, I would recommend producing a report comparing it with the harmonised standard and identifying the differences. where differences occur you will need to justify why it is still in conformance with the essential requirements