Over labeling CE marked products

[Jlt13]

Hi,

If I were to distribute a class III medical device from Germany to Brazil affiliate (Brazil affiliate would then distribute to customers), would Brazil affiliates be allowed to add Brazil local regulatory requirements by over labeling? This would be a CE-marked product being distributed to Brazil. Germany would be considered the legal manufacturer, not Brazil affiliates. If not allowed, what governing regulations not allow this over-labeling practice?

Thanks.

 

[DanMann]

If I'm understanding you correctly - EU law does not apply to products distributed to Brazil, so your distributor can overlabel the CE mark label as long as:
1. Your QMS covers this re-labelling activity with your distributor as a supplier of this activity.
2. You and your distributor in Brazil meet the Brazilian regulatory requirements for the appearance and application of labels (e.g. language, label content, resilience of the label).
3. You meet the Brazilian regulations for product safety and registrations.