Isabel Sottomayor Created: Sep 20, 2022 Last commented: Sep 22, 2022

Mandatory information in Conformity Declaration for Medical Device Class I

Hello, I have a Conformity Declaration from a supplier for MD Class I non-sterile, under MDR 2017/745, that identifies the product with "name", "model" (uses the references of the products), "GMDN" and "Classification" (Class I). There is already a text field for "Basic UDI-DI", but is still empty. Recently I asked for a new product class I with a new reference, produced only for us. I asked for an update of the Conformity Declaration and the supplier told me the one I have is enough for the new reference because it is under the same "Name" and "GMDN". Is that correct? Doesn't the MDR oblige to an "unambiguous reference allowing identification and traceability of the device", for this one in particular? Shouldn't the supplier add the new "Model"? Additionally, when will the Basic UDI-DI be mandatory in these declarations? Thank you, Isabel Sottomayor

Tags: Class I non-sterile, Conformity Declaration

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Kristina Zvonar Brkić Sep 22, 2022

If the new product has the same intended purpose, same name, and same GMDN, then yes, it is not necessary to have a new Declaration of conformity. This situation is called medical device family and for one medical device family, it is OK to have a unique Declaration of conformity. Usually, in cases when there are a lot of models, then there is an annex to the Declaration of conformity with the whole list of models.

What I am concerned about here is the use of GMDN codes. EU published EU codes which are called EMDN codes and all medical devices under the MDR must have that codes. In the links are EMDN codes and a database where you can find which codes are applicable for your medical device family.

For more information, see:

European Medical Device Nomenclature (EMDN) https://webgate.ec.europa.eu/dyna2/emdn/

Considering the UDI, for the class I medical devices, according to Article 123, the deadline for implementation of UDI is May 2025. So, this means that there is still no need to have a BASIC UDI on the Declaration of conformity.

For further information, see:

EU MDR Article 123 - Entry into force and date of application https://advisera.com/13485academy/mdr/entry-into-force-and-date-of-application/

The next thing which is important to be on the Declaration of conformity according to the MDR is the Single registration number (SRN), so please check if that information is on it.

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