Class ll medical device labelling


Starting to get Involved
We manufacture(in Canada) and sell a class ll medical device.
This device is supplied to US, UK, EU, Australia, and Turkey. Can we use a universal label which contains information of all the Reps from different regions on the product? or do we have to make individual labels for individual countries the product is being sent to?


Trusted Information Resource
Best practice would be to use individual labels. Each region has at least one unique symbol or text they want to see.
Unfortunately, harmonization in labeling has not occurred.



Involved In Discussions
Regarding EU it shouldn't be a problem to use a multilayer or booklet and give the text for different countries, also incl. giving country specific information, but which needs to make sure, that this information only accounts for a specific country. I regularly have such labels for substance based devices and it never was a problem. Even UK was/is integrated.
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