Medical Device Expiry Date or Manufactured date - really?

DMLqms

Starting to get Involved
#1
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.

Cheers

D
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Hi - under what country's system?

I've made class 1 re-useable products (for US and EU) in the past and we did not include a shelf life or expiry as the life of the product depended on frequency of use and environment. They could conceivably last forever with proper care.

Are the instruments sold sterilized? That would warrant a shelf life
 
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