M
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.
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.