Article 22 procedure pack risk analysis

[TomQA]

Hello,

We're going to EU market with a procedure pack containing 1 of our own devices (SaMD) and 3 non-medical but CE marked products by other manufacturers. We have verified the mutual compatibility of the different products in verification and validation activities.

However, do we need to generate a risk analysis of the use of the procedure pack? And where do we document it?
Plus, does someone have a checklist of documents to generate for the procedure pack ?
Thanks!

 

[TomQA]

Anyone can help please?
Thanks!

 

[DanMann]

I think you will have to risk assess the procedure pack, but not because procedure packs require a risk assessment specifically, but because the SaMD's interactions with the procedure pack contents needs to be considered as part of the risk assessment for the SaMD.
What are the other products being put into the procedure pack for a medical procedure that are not medical devices? I've never quite understood the idea behind Article 22 1.c.
I'd also be a little concerned about how you are "combining" a SaMD with some physical objects and how this isn't providing three medical device accessories with your SaMD.
I refered to the items mentioned in article 22 (assuming no sterilisation is involved):

• A document explaining how mutual compatbility of the devices/products was confirmed and what their intended uses are.
• A document explaining how the manufacturer's IFU /(or equivalent for non-medical products) is included with the procedure pack.
• A document explaining the manufacturing/repackaging procedure for the procedure pack.
• A copy of the packaging design showing a lack of an extra CE mark and the UDI (if you're at this point yet).

 

[TomQA]

@DanMann Thank you very much for your answer !