Hi Anon,
some additional thoughts to the information already given by Richard and Stephanie:
Medical devices in Europe are regulated in line with the new legislative framework or new approach that relies to a great deal on manufacturer responsibility and self-control. This includes the general concept of conformity assessment: The manufacturer proves that their product conforms with the respective EU requirements (usually defined in an Annex to a directive or a regulation) and documents this in a Technical Documentation. For more risk-prone products this is accompanied by assessments of Notified Bodies (companies that have been authorized by the member states to perform the respective assessments). There are several different general concepts for conformity assessment procedures, and each specific directive/guidance needs to specify which procedures work for which cases.
For the MDR the conformity assessment procedures are detailed in Annexes IX, X and XI (and Article 52(7) for class I) and which procedure (or combination of procedures) can be applied depends on the device classification and is detailed in Article 52.
In theory Annex IX focuses more on the QMS part of conformity, including your design and development processes, and would usually give you more freedom to implement device changes or even introduce new devices within the scope of your QMS without a separate approval by the notified body. Annex XI (usually part A of Annex XI, part B would require the testing of each single device by the NB), for higher risk classes used together with Annex X) would focus more on quality assurance with additional more detailed review and testing of device types (that's where Annex X comes in), resulting in less flexibility with respect to device changes.
However, because the MDR in Article 10 requires a full quality management system (including design and development) anyway, my current experience is that the NBs do not really know how to limit their audits for Annex XI procedures. And because there is so much focus on TD reviews, these tend to be equally detailed for Annex IX procedures (and often the NB will require you to at least report changes anyway). So in reality the line between these procedures has pretty much blurred (and you can see that in the BSI paper Stephanie linked where the activities of the NB are depicted as more or less identical even though different procedures might be applicable).
With respect to your choice: One important consideration is how many different devices and what types of devices you want to place on the market overall. You should make sure that the route you choose can cover all these devices and that the respective procedures are within the scope of your NB (you can find that out from the NANDO database, just as an example the notification of KIWA CERMET ITALIA does not cover Annex X at all, so if you start with a class IIa device with Annex XI and TD review and then wanted to add a class IIb device that in addition requires Annex X, this would not work with this NB).
One additional question you could ask your NB (and that they can hardly deny as guidance) is how their activities would differ with the different Annexes. Is an Annex IX audit longer than an Annex XI audit? And would a (sample) TD review under Annex IX be longer or shorter than a review (and maybe testing) under Annex X (if required)?
In the end Annex IX probably is more flexible and in scope for more NBs, so if your portfolio is not very limited or specialized, this might be the safer choice.
If you have additional questions or would like more information, just let me know.
Best regards, Christoph
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Christoph Kiesselbach
Schrack & Partner
Reutlingen
Germany
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Original Message:
Sent: 03-Apr-2024 14:48
From: Anonymous Member
Subject: Annex IX vs Annex XI
This message was posted by a user wishing to remain anonymous
We decided to take our product into EU for the first time, and the NB we're working with said we have to decide between Annex IX and Annex XI for their assessment, and they can't give any guidance. I've read both annexes, but I don't think I understand them very well. How do we choose? What is the difference from a practical perspective?