Anon,
In general, most organisations select Annex IX because it is the full quality system and usually this is linked to the ISO 13485 certification. There was a survey or statistics done out there a while back on selection of the Annexes under EU MDD and the majority choosing the full quality system - as it is more straight forward. Annex X for Type Testing would mostly be used for products which require specific testing on lots or very small amounts manufactured. Annex XI can be used for lower risk devices which have been on the market for a long time where the production is well established and design information may even not be necessarily available. For a Class IIa device there are a couple conformity assessment paths could use, would say though again Annex IX is usually the most common.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 27-Oct-2022 02:19
From: Anonymous Member
Subject: Notified Body Selection
This message was posted by a user wishing to remain anonymous
Hello RAPS Community,
In order to select the best Notified Body for the CE marking of our product, we have made a first search according to the applicable horizontal technical competences. Even so, we are not clear which route we should follow for the conformity assessment, Annex XI (A), Annex XI (B), Annex IX (I), Annex IX (II) or Annex X.
I would be really grateful if someone could tell us the implication of each of these annexes and how to decide which one is appropriate for a class IIa active medical device.
Thank you very much.