Medical Device Label Information Requirements in the EU

[SquirrellyGirly]

Concerning Class II and Class III Medical Device Labels: Does the grade of material or just the material have to show on the product package label? Does it matter? (Eg.: 17-4 SST vs. SST) Haven't found specifics in the MDD standards, nor did I see discussions on this in the forums. Would be nice to have a sample label for Class II and Class III. Can someone point me in the right direction? Thanks in advance for all replies!

 

[Ronen E]

Concerning Class II and Class III Medical Device Labels: Does the grade of material or just the material have to show on the product package label? Does it matter? (Eg.: 17-4 SST vs. SST) Haven't found specifics in the MDD standards, nor did I see discussions on this in the forums. Would be nice to have a sample label for Class II and Class III. Can someone point me in the right direction? Thanks in advance for all replies!

Hello and welcome to the Cove

Generally speaking, the materials are not required to be specified in the labeling, neither by grade or generically. This is generally true for class II; for class III it might be less simplistic. It's quite difficult to provide a clear answer without you telling us what the devices are. Typically the exact grade would be a trade secret.

BTW, you mentioned the MDD but referred to "Class II" - in the EC (where the MDD applies) there are either class IIa or class IIb and no "class II".

Cheers,
Ronen.

 

[SquirrellyGirly]

I agree that the specifics are generally trade secrets for our spinal device co. Thanks again for your reply. I only mentioned the Class because that's how I am accustomed to referring to our devices. Now that we are CE, it's a whole new ballgame.

 

[pkost]

There is no specific requirement to list material on a product (for Europe). As part of your risk assessment it may be identified that patients with nickel allergies or similar are at risk if the product is used, there the risk assessment may push you down the route of stating "contains nickel" or the specific material/grade.

It is common in orthopaedics for a large amount of data on the material to be made avaliable to the medical profession as it is so closely linked to the performance of the device and therefore important in their decision making process