Manufacturer Obligation to Declare the Lifetime of its Medical Device?

A

Asherlee

#1
Is there any standard (Europe, FDA or other) that obligates the manufacturer to declare the lifetime of its medical device? I am NOT referring here to the SHELF-LIFE of a device which has an expiry date. Annex I of the MDD (see clause 13.1) says that the device must be accompanied by the information needed to use it safely. Does this include declaring the lifetime of the device??

Thanks.

Asherlee
 
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chris1price

Trusted Information Resource
#2
Re: Obligation to declare the lifetime of its medical device?

Have a look at ISO13485 4.2.3 and 4.2.4.

"The organisation shall retain records for a period of time at least equivalent to the lifetime of the medical device as defined by the organisation......"

Based on this, you would normally be expected to state the lifetime of the product, either in a procedure, quality manual, technical file or similar controlled document.

This lifetime might be the same as the shelf life or it can be a longer depending on how you expect the product to be used. I would not expect the see this lifetime quoted in the IFU, unless it involved safety implications.
 

Ajit Basrur

Staff member
Admin
#3
Re: Obligation to declare the lifetime of its medical device?

Is there any standard (Europe, FDA or other) that obligates the manufacturer to declare the lifetime of its medical device? I am NOT referring here to the SHELF-LIFE of a device which has an expiry date. Annex I of the MDD (see clause 13.1) says that the device must be accompanied by the information needed to use it safely. Does this include declaring the lifetime of the device??

Thanks.

Asherlee
Declare where ?
 
A

Asherlee

#4
Thanks for the input.

I would like to reword my question as follows:
May I determine the ‘lifetime’ of an active device by the period for which the manufacturer will support the device with spare parts, manuals, training, service, or repairs (for example); or am I obligated to carry out MTBF or ALT or other testing in order to backup and support any claim that I make for the lifetime of the device (irrespective of where I make this claim, be it in an internal document or in the IFU)?

Thanks.
 

chris1price

Trusted Information Resource
#5
In my experience, in this context the life-time only becomes an issue when deciding how long documents need to be retained for. In general MTBF type testing should not be required. The lifetime is really a justification for your record retention times and I would base your rationale for retention around lifetime. I would add the lifetime into a suitable procedure, such as document control. There's no requirment to put it into an IFU unless there are safety of commercial reasons.

Also, have a read through ISO14696, Section 7.1.3, which says that the ...lifetime may be based on technical, legal, commercial or other considerations...", and then expands on it further listing numerous items to consider. It also says the rationale should be documented.

One last observation, in the past I have been written up in a 13485 audit for not having the lifetime defined anywhere!
 
J

Jim Shelor

#7
I have a pacemaker installed. I certainly hope the lifetime of the battery (7 years) is an accurate number.

If there are no requirements for a medical device manufacturer to provide the lifetime of the device, there certainly should be.
 
B

babarian

#8
Dear all:
shelf life and lifetime is different:
shelf life normally connected with "used by", and shall be shown in labelling or IFU.
lifetime is more likely connected with active device and re-usable device, and do not shown in labelling, but maybe need to be shown in IFU according to relevet product/ general standards.

more informaiton can refer to the "Guidelines relating to the application of derective 93/42/EEC on medical device-- "use by" "date", 2_2-3_06-1998.pdf", this file can be download free from the official website:)

Regards.
 

somashekar

Staff member
Super Moderator
#9
Would It be OK if you consider the lifetime of the device in your design input and go about your design process, there by the lifetime is defined in the DMR and going further based on this DMR lifetime defined by the organization, all records retention can be aligned. The device may be useable beyond the lifetime and so this info is not into the product IFU unless safety to the user or patient is involved, in which case you term it as "use before" period.
 
B

babarian

#10
Would It be OK if you consider the lifetime of the device in your design input and go about your design process, there by the lifetime is defined in the DMR and going further based on this DMR lifetime defined by the organization, all records retention can be aligned. The device may be useable beyond the lifetime and so this info is not into the product IFU unless safety to the user or patient is involved, in which case you term it as "use before" period.

Hello Somashekar:
I think it is ok:
3. How to decide if a “use-by“ date is required:
A “use-by“ date is required where a safety-related characteristic or claimed performance is likely to deteriorate over time.
In deciding whether there is such a "safety-related" deterioration, the manufacturer must have regard to the results of the risk analysis and measures taken to manage risk. with sub-section a), b), c)
and
4.2 Information necessary if a “use-by“ date is not given:
B R
 

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