Another question along the same line, related to the Conformity Assessment Route on the Declaration of Conformity (DoC).
We received an NC after a Technical Review stating that our EC Declaration of Conformity does not fully meet the requirements of Annex II. The conformity assessment route (Annex II section 3.2) was not included in the declaration.
What was included on the DoC in this space was Annex II excluding section 4.
Our devices are Class IIA per Rule 7 of Annex IX.
Help in understanding which on is correct and WHY would be appreciated. I looked at the NC-MED consensus statement S99/01 (or S/01/99 depending on how you look at) and it was no help.
Thanks - Mary
Hello Mary and welcome to the Cove
The MDD doesn't spell out a requirement to state the conformity assessment route (at any level of detail) on the DoC. All it requires is a declaration that the applicable requirements of the directive have been met.
NB-MED S/01/99 doesn't include such a requirement (or recommendation) either, and it is outdated anyway.
The closest I saw was in DECISION No 768/2008/EC, Annex III (#7) - it requires a "description of intervention" where a NB is involved. Basically the NB works by the requirements in the relevant Annex / sections, so noting the Annex and sections could be a concise way to describe their intervention; however, this is not prescribed in the Decision, and I could conceive of other ways as well...
Insisting on "Annex II section 3.2" instead of "Annex II excluding s. 4" seems to me either over-pedantic or just petty (or both

). Perhaps it's the result of some legal advice the NB received in the past. Either way, I would have taken the practical approach and just modified it to their liking. As I usually say, pick your battles. Sometimes it's more important to be wise than right.
Cheers,
Ronen.