Requirement 4 of MDD 93/42/EEC - Definitions of Lifetime, Life Cycle, Shelf Life

A

ardalan

#1
Hi,

in one of audit report technical file review of a single use medical device; the technical file reviewer, raised following note against essential requirement 4 of MDD 93/42/EEC:

" In response to ER 4 please provide information about the defined product lifetime (not shelf life)."

Would you please compare these three term:
Lifetime
Life cycle
Shelf life

regards,
Ardalan
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: Requirement 4 of MDD 93/42/EEC - Lifetime, Life cycle, Shelf life

I'm not a MDD person, but...

Lifetime - The expected life of a product (such as in years).
Life cycle - What a product goes through from manufacture to actual use to disposal/recycling.
Shelf life - The time a product can be stored before it is not fit for its intended use.
 

pkost

Trusted Information Resource
#3
Re: Requirement 4 of MDD 93/42/EEC - Lifetime, Life cycle, Shelf life

Rough definitions are:
Lifetime...from when first placed on a shelf until thrown in the bin
(Product) Life cycle... From initial design until the last one ever made is disposed of
Shelf life...time product can be sat on a shelf unused before no longer functioning correctly (particularly applicable to sterile product)


Specifically in relation to ER4, assuming say a hip joint replacement implant...the joint will be exposed to many well documented stresses...chemical, mechanical, biological etc.

ER4 requires that you demonstrate that the hip is capable of withstanding these stresses throughout the time it is implanted in a patient; e.g. there is cyclical stress...will the product fatigue? the head and cup will wear....will the wear be to the detriment of the function of the device and if so after how long?
 
Last edited:

Ronen E

Problem Solver
Staff member
Moderator
#4
Hi,

in one of audit report technical file review of a single use medical device; the technical file reviewer, raised following note against essential requirement 4 of MDD 93/42/EEC:

" In response to ER 4 please provide information about the defined product lifetime (not shelf life)."

Would you please compare these three term:
Lifetime
Life cycle
Shelf life

regards,
Ardalan
I would say that the term "lifetime" in requirement 4 relates to what is often termed as "use life", i.e. the maximum duration allowed by the manufacturer in the labeling. In case of a device used intermittently that would be the period from commencing the use of a certain unit until the same unit is taken out of service.

the sentence "when the device is subjected to the stresses which
can occur during normal conditions of use" loosely indicates that this period excludes any shelf life, i.e. the time elapsed from the end of manufacture (or commencement of manufacture for some types of devices) until actual use is started.

Cheers,
Ronen.
 
Last edited:

Sam Lazzara

Trusted Information Resource
#6
The ISO 10993-1 biological evaluation standard categorizes medical devices according to the nature and "duration" of body contact. The duration of contact is the "use life" or "service life". In this standard there are 3 duration choices - limited (<24 hrs), prolonged (24 hrs to 30 days), and permanent (> 30 days).

The Medical Device Directive classification system has 3 duration categories as follows:
Transient - Normally intended for continuous use for less than 60 minutes.
Short term - Normally intended for continuous use for not more than 30 days.
Long term - Normally intended for continuous use for more than 30 days.

I have attached the classification guidance. The guidance discusses what "continuous use" means.
 

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