Strategy for Free Sale Certificate issuance?

[IS1027]

Hi everyone,

I was wondering if you all have any strategy or particular structure for your FSC, in terms of what information to include, what products to include, and how to name each of them. I know that per MDR the requirement is to be able to identify unequivocally every product (UDI-DI Basic). But how about:

• Product names: I was considering simply putting the product name as it is in our company's management system, which would also coincide with orders, invoices, stock, etc.
• Products listed: I wanted to know your opinion on what products to list. Is there any disadvantage in just listing all the company's products in the same FSC template? Aside from having a lengthy document (depends on how many products the company has), I can't think of any. It would not only be convenient because there would be only one template, but also because the distributor would have all products listed, just in case.

 

[Cybel]

Hi, not sure what you mean. FSC is issued by the authority of your country. They would provide their forms to fill in, and the final structure of the FSC is up to them. FSC is Free Sale Certificate. I don't think MDR gives indications on this matter.
Do you mean DoC (Declaration of Conformity) instead? If so, my DoCs include all the products (and their product codes/names) that have the same basic UDI-DI. The list of the information you shall include in the DoC is provided in Annex IV of MDR.

 

[IS1027]

Hi, not sure what you mean. FSC is issued by the authority of your country. They would provide their forms to fill in, and the final structure of the FSC is up to them. FSC is Free Sale Certificate. I don't think MDR gives indications on this matter.
Do you mean DoC (Declaration of Conformity) instead? If so, my DoCs include all the products (and their product codes/names) that have the same basic UDI-DI. The list of the information you shall include in the DoC is provided in Annex IV of MDR.

Hi, I do mean FSC.

The MDR does, in fact, give indications about the FSC: Article 60 Certificate of free sale

I know it is issued by the authority of each country, but the information included is provided by the manufacturer. The manufacturer is the one that chooses which product names to list, whether to include internal reference codes, whether to include UDI-DI Basic, etc.

 

[Cybel]

So, in this case, you can provide the complete list of your products (including basic UDI-DI, model, product name of each, as they appear in your technical documentation/DoC/CE certificate), listed according to the format provided by your authority.