Oldvatr
Expert
- Messages
- 8,470
- Type of diabetes
- Type 2
- Treatment type
- Tablets (oral)
Acording to the info supplied with the test strips, purchased this year, then the accuracy is defined in accordance with ISO 15197:2013 and so is not certified to the required standard. The note in the leaflet says that this accuracy is only valid for a limited time, but does not state what this limit is. in terms of the manufacture date.Your experience of CE marking is different to mine then!
I am currently working in the medical device industry (radiotherapy) and have spent the last 8 months writing reports for a notified body (not TUV) to get our equipment approved to a revised and updated standard before the cut off date - or we stop shipping.
Medical devices can no longer carry the CE mark after the enforcement date of the latest standard (in the case of glucose test meters - 2016.) unless they fully meet the requirements of that standard.
The enforcement date may differ from country to country (China are typically a few years behind) but across the EEA it is standardised.
The meter performance is only to an earlier version of this standard (2003) according to same leaflet, so the meter has not been recently re-qualified. The SD leaflet was last updated in 2014, so will not show any data to the required 2015 (or even 2016/17) standards.