The importance of CE marking revisited

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The announcement by Abbott that it received European CE Mark approval for its FreeStyle Navigator Continuous Glucose Monitoring System for people with diabetes (interesting press release, by the way) reminded me of the importance of this issue for companies that want to sell into the European ‘medical devices’ market and, indeed other markets, such as electrical goods. Conforming to the required standards is such an important point that PASA makes it a fundamental criterion for inclusion of equipment on the National Framework Agreement.

I was also reminded that, as I understand it, for a ‘system’ to comply with the CE requirements all its component parts have to be compliant too, otherwise the CE marking for the whole system is invalidated. Maybe it is worth checking all the elements of the health monitoring or telecare kit you are using. But, in view of the regulatory and legal liability issues, if you find something that appears to be non-compliant tell PASA, not me!