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Can year of manufacture be omitted from the instructions for use?

M

mr.mike

#1
Hi There,

Am I nit-picking here? I think there may be an omission in the MDD essential requirements section (Annex I):

Section 13.6(a) states that all details referred to in section 13.3 (the labelling requirements), shall be present in the instructions for use, with the exception of (d, batch/serial) and (e, "use-by" date).

Should there not be also allowance to omit (l), the year of manufacture?

Year of manufacture is included in the serial number labels affixed to the device itself (as per section 13.3(l)). But the User Instructions Manual is independent of this (same one will be used for next year's units, assuming no changes).

We include the revision number and revision date on the User Instruction Manual, however this does not give the year of manufacture of the device it accompanys.

To me, it seems ridiculous to have to include the year of manufacture in the User Instructions, as the instructions are meant to be independent of specific devices.

Anyone care to comment?
Thanks,
MM.
 
M

MIREGMGR

#2
The rule writers put a higher priority on assuring that users would not be confused as to what IFU was to be used with what device, than they did on saving manufacturers money.

I think they were envisoning a scenario in which a user would simultaneously have two generations of the same device-type at the same procedure-site, with a significant use-change having been made between the two generations.
 
M

mr.mike

#3
I think they were envisoning a scenario in which a user would simultaneously have two generations of the same device-type at the same procedure-site, with a significant use-change having been made between the two generations.
Hmmm, I guess I can see the reasoning, but if that were the case, year of manufacture on the IFU would be insufficient to prevent the scenario you describe (unless you release the next gen. Jan 1st, you will always have different generations within a given year).

It seems to me, that if the MDD allows for the omission of specific device batch/serials in the IFU, then it makes sense that the year of manufacture also can be omitted.
(i.e. if they were truly concerned about the scenario you describe, you would have to include the device batch/serial in the IFU).
 

somashekar

Staff member
Super Moderator
#4
Hmmm, I guess I can see the reasoning, but if that were the case, year of manufacture on the IFU would be insufficient to prevent the scenario you describe (unless you release the next gen. Jan 1st, you will always have different generations within a given year).

It seems to me, that if the MDD allows for the omission of specific device batch/serials in the IFU, then it makes sense that the year of manufacture also can be omitted.
(i.e. if they were truly concerned about the scenario you describe, you would have to include the device batch/serial in the IFU).
Is that not precisely the 13.6 is trying to say in the beginning ... Where appropriate, >>>
:)
I think the good judgement is left to the manufacturer.
 
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