When is a Manufacturing Date required on Medical Device Labeling?

[Mark Meer]

Hi everyone,

Years back, we had decided to include the date-of-manufacture on our Class II (non IVD) device labels.

Now, I can't for the life of me recall the rationale for this decision.

Is there a particular regional regulatory requirement someone could point me to that requires the manufacturing date be present on medical device labelling?

Thanks!

 

[Ronen E]

Re: When is manufacturing date required on Medical Device labeling?

Do you also show the expiry date?

 

[Mark Meer]

Re: When is manufacturing date required on Medical Device labeling?

No, there is no expiry date.

...and these two dates (expiry date versus manufacturing date) appear to be independent as far as labeling frameworks go. For example EN980 and GS1 have distinct symbols/identifiers for specifying the two dates independently...

 

[Mark Meer]

Re: When is manufacturing date required on Medical Device labeling?

Found one reference:

MDD 93/42/EEC, Annex I, 13.3:
"The label must bear the following particulars:...
(l) year of manufacture for active devices other than those covered by
(e). This indication may be included in the batch or serial number;"

...however this just calls for the year, and only for active devices.

Anyone know of any other medical device regulations or standards that require date of manufacture to be on the labelling?

 

[Ronen E]

Re: When is manufacturing date required on Medical Device labeling?

If there's no expiry date but the device has a definite shelf life, the manufacturing date would be required so that the user can avoid using the device beyond its shelf life.

It's a bit difficult to relate to your specific device if we don't know what it is.

 

[Mark Meer]

Re: When is manufacturing date required on Medical Device labeling?

We've applied this across our products, so there is a bunch (they're all Class II though), and none have an expiry, or stated shelf life.

I'm more curious about where the (perceived) need for this date came from. Like I mentioned EN 980 and GS1 have both constructed explicit symbologies/identifiers for putting manufacturing date on device labels.... but, aside from the MDD reference (which only requires the year, and has an option to just include it in the batch number), I can't track down any explicit requirement (in regulations or standards) that requires this date to be present (and hence any need to use EN 980 symbol, or GS1 application identifier)...

Bottom line is that, for a number of reasons, I'd like to get rid of it on our labels. I'm just trying to confirm that we are not removing labeling information required by a medical device regulation or standard.

 

[Ronen E]

Re: When is manufacturing date required on Medical Device labeling?

none have an expiry, or stated shelf life.

So technically they can be used for a hundred years?... Even if you don't state it on the labelling, there must be a defined device lifetime to inform your verification etc. The default would be "indefinite lifetime", which you probably don't want to support (even if you can).

The MDD's Essential Requirement 4 reads:

The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical condi-tions and safety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use.

(Emphasis added), so you "kind of" have to address the issue one way or another.

Other than that it's still hard to say... "Class II" is still quite general. There might be Special Controls in place.

 

[Ajit Basrur]

Re: When is manufacturing date required on Medical Device labeling?

Would the manufacturing date or an expiration date be not required per UDI requirements ?

 

[Ronen E]

Re: When is manufacturing date required on Medical Device labeling?

Would the manufacturing date or an expiration date be not required per UDI requirements ?

Not as a general rule.

 

[somashekar]

Re: When is manufacturing date required on Medical Device labeling?

EN980 provides for the symbol. However the use of the symbol and the information alongside is an output from your risk assessment concerning device labeling information. Just a case., if the device has an adhesive backed part, the Mfg date (MM/YYYY) leads to the declared use before period, which can be., say 18 months from the Mfg date. This comes from the shelf life of the adhesive backed part. In fact the storage and transport temperature information also directly has an effect on the use before period.
So what is your Mfg date information's clarity and sincerity of the purpose .....