MDR Conformity Assessment Routes

[petesi]

Hi everyone,

In what situations are conformity assessment based on Annex X and Annex XI-Part A/B relevant?

Even after reading the MDR, guidances and NoBo websites I have not been able to figure out the strategic considerations for choosing the conformity assessment route.

I have only ever been involved in QMS + TD (Annex IX) conformity assessment procedures which seems to be the default route most are choosing. However, for many of the risk classes we are free to choose other conformity assessment routes. Could anyone either explain when and why these routes could be relevant or point me towards a guidance document or similar that explain this?

BR

 

[Ronen E]

Indeed Annex IX is the default. I'm struggling to remember cases where the manufacturer used the other Annexes. In my understanding they are more limiting, and might (?) be relevant in cases of very low overall unit count (<10), as in specialized and complex equipment. For mass production it's pretty much always Annex IX.

...unless I'm missing something!

 

[Philip B]

We are a manufacturer and do large scale production but we are Annex XI Part A. I seem to recall it was due to the fact we don't design our devices.

 

[chris1price]

Annex XI-Part A requires a production QMS, ie no design controls.
Annex X with part of XI is for type approval, which is typically low volume production, with either a production QMS or verification of each product by a NB. There are a lot of permutation to Annex X+XI, so best clarify with your NB exactly what they require.

 

[Ronen E]

Annex XI-Part A requires a production QMS, ie no design controls.
Annex X with part of XI is for type approval, which is typically low volume production, with either a production QMS or verification of each product by a NB. There are a lot of permutation to Annex X+XI, so best clarify with your NB exactly what they require.

Yes, sorry, I forgot about the Production QMS route. Did not have the pleasure (yet) of taking that route with a client under MDR.
I was referring to the type examination / verification routes.