Thread starter milagre Start date Apr 7, Hi everyone, I work for a small medical device company in Vietnam. Do we need to notify a Competent Authority of this if we do not intend to market the device in the EU? I think we do, but I am not sure.
Identify the competent authority
If it helps, we currently have a Class IIa device infant phototherapy unit on the market. Apr 7, Re: Class I device - need to notify CA if selling in Asia If you are not in the EU and are not intending to market the product in the EU you do not have to comply with any European requirements including not not limited to applying the CE mark or notifying a european competent authority.
If you are selling into a market that assumes compliance with local regulations for products that have a European CE mark, this is a different discussion and you would need to clarify with more specific information.
For example, a government tender could list one of the required specs as a CE-marked device. These customers are not in countries that have officially adopted the MDD, but the buyers require it for devices they purchase.
Our motivation is to meet the requirement of these buyers. I understood from reading that Class 1 devices without measuring functions could be self-declared without involvement of a NB, but I am not sure how we go about notifying the Competent Authority ourselves, and I am also not sure if it is necessary for us to do so, considering we don't plan to sell to the EU or to countries that have adopted the MDD as law. I'm not really sure if gave the specific information you were looking for.
If I didn't perhaps you could specify what kind of info you would be necessary to better understand my question.
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