Guest user Created: Jun 24, 2021 Last commented: Jun 26, 2021

MDR and Contract Manufacturer

We are a *** based company who manufacture dental instruments, under the name of ***. a) We export to EU and USA, b) We do not sell by our own name c) We stamp the brand or name of the company we export, on the instruments. Now, we are in contact with a European company for acting as our EU AR. They say: ***, by MDR definition, is not a "legal Manufacturer", as *** is not selling in the EU by its own name or brand. So we can not act as *** EU AR. My questions are: 1. Are they right in their observation? 2. We need aan EU AR or not? 3. If not, then, what should we declare on the labels, *** as Contract Manufacturer? Please help us and guide us in this regard.

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Kristina Zvonar Brkić Jun 26, 2021

The main question here is who certified the medical devices (in your case dental instruments). Who has the CE certificate? You mentioned that you do not sell by your own name. In that case, the comment from the EU Ar company is right. EU AR can be a representative only for the products and the company that puts the products on the market.

If I understand your situation correctly, you are outsourced production for the company that puts dental instruments on the market. In that case, you do not need an EU representative.

Yes, on the label you can state that *** is a contract manufacturer or a place of production (using the white factory symbol).

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Jun 24, 2021

Jun 26, 2021

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