Difference between EU-MDR Annex IX and the Annex-combo X&XI

[Son of Paperman]

Having compared the EU-MDR's Annex 9 and Annexes 10 & 11, it's still not clear to me what the difference is, and why you would choose one route over the other. The similarities and the continues cross-referencing make it very confusing.
At first I thought in route 9 the manufacturer does everything and in 10&11, the notified body does the work on behalf of the manufacturer (sort of like it was in the IVDD Annex 5) but having compared route 9 with the combo 10&11, I get the impression that is not the case.
So what is the difference, and why?
I have visited webpages of various notified bodies with explanations that don't clarify that most essential question. After all, if that is not clear, how can you know which route to take?

Thank you in advance to those that bring clarity.

 

[yodon]

Not exactly an expert here but I don't believe these are (in principle) much different from the MDD (Annexes II - IV). Those are 3 different conformity routes.

• Full QMS (MDD Annex II / MDR Annex IV) means you have a Quality System certified to the standard, your product is built accordingly, and your technical documentation is assessed to ensure everything is in order.
• EC Type Examination (MDD Annex III / MDR Annex X) means that the NB does sampling on your product to ensure conformity.
• The EC Verification route means 100% of product is verified (I think by the manufacturer) to meet the regulations.

I've not been in a situation where either of the last 2 routes were used so I may have butchered them a bit in describing. (Hopefully someone will jump in and correct.)

 

[Son of Paperman]

Thank you very much for you reply and explanation Yodon. It confirms my interpretation.
If there is an error in your explanation, you formulated it so succinctly (and better than I ever could have done) that respondents can react easily and clearly to it.

 

[claudemak]

I still don't understand the difference between the routes. When would a manufacturer choose the second route over the first for example? Is it when they don't have a QMS in place at all, and just have one manufactured device for example? When would you choose one route of over the other?

 

[RobertvanBoxtel]

As indicated by @yodon above, QMS wise: Annex IX MDR ~ Annex II MDD and Annex XI Part A ~Annex V.
Following Annex V in the past was necessary in case you did not / could not implement a design control process. Or, the NB determined it was not an effectively implemented QMS on D&D, not giving you the relative freedom to make certain design changes yourself without their involvement (see NBOG 2014-3 for details).

Roughly this comes back in Annex XI Part A: The main difference between Annex IX and Annex XI Part A concern the statement in section 6.2 of Annex XI: Apply Annex IX section 2.2 elements a, b, d, and e. What's missing? right: element c - Design control elements from Annex IX.