Expiry Dates on a Non-Sterile Class 1 Medical Device (5 Year Shelf Life).

[Quality Priest]

I wanted to gauge some feedback from you guys regarding Non-Sterile Class 1 Medical Device, we are acting as an intermediate and have started to see customer queries regarding expiry dates on a Non-Sterile Class 1 Medical Device.
The device in question currently has a 5 year shelf life.
I can see the logic from a business point for placing an expiry date on the product, however is there a legal requirement for this?

Look forward to your comments and feedback.

Thanks
QP

 

[rob73]

Re: Non-Sterile Class 1 Medical Device.

MDD 13.3 (e)
"where appropriate, an indication of the date by which the device
should be used, in safety, expressed as the year and month;"
It is very difficult to justify a case where a "use by" or shelf life is not applicable.
Rob

 

[pkost]

Without knowing the device you are referring to, it is difficult to say whether an expiry date is appropriate/necessary.

Rob's quote above is correct in that if it is appropriate, it should indicated, I don't however quite agree with it being hard to justify not using one. There are many devices that won't stop working effectively after a period of time, their failure is more instead linked to the amount of usage; in cases like this an inspection process to identify potential problems serves to avoid the use of an expiry date (in these cases you have to specify a manufacture date)



In your role as a distributor you have to do what the manufacturer says, if they say it expires on a certain date then you cannot sell them and you could be put in a sticky legal situation if you made any claim to the contrary.

You seem to imply/suggest that the manufacturer has put the expiry date on to encourage more sales, this is an inappropriate use however there is not much you can do to stop them. If they are doing this then the best approach is to speak to them and point out the negative perception their customers will have of their company as a result of their attempt to squeeze more money. If the device will truly expire after 5 years then get them to explain why, you can pass this onto your customers as an justification and explain the ramifications of ignoring the useby.

 

[rob73]

Everything suffers with ageing (I know I do), so it is difficult to perceive a situation where a shelf or use by would not be appropriate. The length of life is another matter, I am sure that many companies use this as a way of pushing up sales. As you suggested the OP should ask the manufacturer to justify the five year shelf life and the risks involved in using the product past this time.
Also shelf life may not necessarily be the end of the product life, a regulator may have a five year "shelf life" but it could (and probably would knowing the NHS budget) used and maintained long after this date.
Rob

 

[Quality Priest]

Thank you both for your comments, much appreciated. I have been more used to dealing with sterile devices, so hadn’t applied the same rulings.

The device in question is a single use airway management device, as you can appreciate this kind of device may well sit around for the shelf life and be un-used.

Sorry if I seem to imply marketing tactics on the initial post, I don’t think that cost of the device would really make much difference over a 5 year period.

 

[pkost]

Everything suffers with ageing (I know I do), so it is difficult to perceive a situation where a shelf or use by would not be appropriate. The length of life is another matter, I am sure that many companies use this as a way of pushing up sales. As you suggested the OP should ask the manufacturer to justify the five year shelf life and the risks involved in using the product past this time.
Also shelf life may not necessarily be the end of the product life, a regulator may have a five year "shelf life" but it could (and probably would knowing the NHS budget) used and maintained long after this date.
Rob

While I agree everything degrades, there are plenty of "simple" devices that do not degrade in any meaningful way if stored in an appropriate environment, perhaps I am biased towards my orthopaedics background where instruments tend to be solid lumps of metal and plastic and you will be hard pushed to find an instrument with a useby date

 

[DMLqms]

Hello All, I'm very much interested in this - we have a large number of Class I, II and IIa devices - many of which have no stated expiry date or similar on the labelling.

Many of the Class I devices are 'simple' metal/plastic orthodontic products - sold only to professional orthodontic/dental professionals with the relevant Lot number controls in place.

We are the OBL/virtual manufacturer - do we really need an expiry date on everything or can we state the shelf-life in the IFU?

Any help appreciated.

 

[Ronen E]

Hello All, I'm very much interested in this - we have a large number of Class I, II and IIa devices - many of which have no stated expiry date or similar on the labelling.

Many of the Class I devices are 'simple' metal/plastic orthodontic products - sold only to professional orthodontic/dental professionals with the relevant Lot number controls in place.

We are the OBL/virtual manufacturer - do we really need an expiry date on everything or can we state the shelf-life in the IFU?

Any help appreciated.

Hi,

I’m assuming that you operate in the EU market (“OBL / virtual manufacturer” is an EU terminology). Please note that in the EU there is no class II, only IIa or IIb.

Further, current approach to “OBL” (or the likes) is that they assume exactly the same responsibilities as an “ordinary” manufacturer. Whatever applies regarding expiry dates, applies to you as the legally responsible manufacturer.

Where an expiry date is indeed required in the labelling, whether it has to be on the device itself or can be on the packaging / an insert (eg IFU) has nothing to do with you being or not an OBL. It is mostly a matter of device size and practicality. I’d venture a guess that small devices that go inside the oral cavity don’t need labelling (expiry or otherwise) on the device itself, but that’s pending a serious review by someone who knows exactly what the device is and what the intended use is.

In general the responses from rob73 and pkost are good. I’m of the opinion that unless you can document and back a science-based justification why device life is infinite (=no expiry), there has to be some sort of expiry specified. In short, there’s no easy escape path, either you build a case for a specific life span or you build one for infinite life.

Cheers,
Ronen.

 

[locutus]

Just a further comment that I know confuses people - these may not all the same and different for a type of device:
- Shelf life (commonly associated with sterile devices)
- Expiry date (degradation due to a component)
- Usable life of device (how long device lasts under normal use)
- Lifetime of device (how long device lasts)
- Marketing lifetime of device (how long actually sold)

According to most regulations, and now more prominent in the MDR, the lifetime of device needs to be defined. Some of these may be the same and some may be different. The actual shelf life or expiry date may not need to be shown on the labeling if the package has a long lifetime (5 years). Though it may be required without knowing the exact device.

This is definitely an area that does have some confusion and many, many different interpretations. So the above mentioned is my own perspective, but certainly would like other's opinion because over the years talked to dozens of auditors and all had their own interpretation .

 

[DMLqms]

Hi Ronen,

Thanks for the response - yes you're right of course - devices in question are Class I/IIa and yes we're in the EU.

I've just clarified this with my NB and as I suspected it is ultimately up to us to establish a safe timeline for the use of the device.

Many of our OEM suppliers state the manufactured date on the labelling as a matter of course but my NB confirmed that this is only an actual requirement for CE marking of active devices (as per MDD Annex I 13.3, l))

Company policy has always been to err on the side of caution so I'll probably recommend we add a manufactured date to the labels.

Cheers

D