NCR under MDD - No documented procedure for class I device registration mechanism

[SilverHawk]

One MDD auditor issued this NCR and the actual wordings as follows, "There is no documented procedure sighted for class I device registration mechanism with relevant national competent authority prior to sale of such products. i.e. latex examination gloves.".

We have been asking the auditor for further clarifictaion and he has yet to reply to us. We are of the opionion that we are equally at lost on how to address this NCR and under which MDD or ISO 13485 requirements that we have to addresss this non-conformity.

Can anyone there share with us how are we going to address this NCR?

 

[wrodnigg]

One MDD auditor issued this NCR and the actual wordings as follows, "There is no documented procedure sighted for class I device registration mechanism with relevant national competent authority prior to sale of such products. i.e. latex examination gloves.".

For a Class I device, you may follow Annex VII (Article 11 (5))

Since you are a manufacturer outside EC, you need an authorized representative inside EC, who acts as your "contact person" to EC competent authorities (Article 14.2):

2. Where a manufacturer who places devices referred to in paragraph 1 on the market under his own name does not have a registered place of business in a Member State, he shall designate the person(s) responsible for marketing them who is (are) established in the Community. These persons shall inform the competent authorities of the Member State in which they have their registered place of business of the address of the registered place of business and the category of devices concerned.

That is what you shall do, and what you should write down either in a contract with your responsible person (authorized representative) or at least in some kind of quality agreement (or a SOP, if you have an "internal" Office inside EC).

 

[SilverHawk]

Thank you, ghw.

I will reply but I do not feel like doing it, anyway.

Regards

KM