M
mr.mike
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.
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.