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Sampling method that is representative of the devices supplied by that distributor
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Sampling method that is representative of the devices supplied by that distributor
Sampling method that is representative of the devices supplied by that distributor
Sampling method that is representative of the devices supplied by that distributor
Sampling method that is representative of the devices supplied by that distributor
Sampling method that is representative of the devices supplied by that distributor
Sampling method that is representative of the devices supplied by that distributor
Sampling method that is representative of the devices supplied by that distributor
Sampling method that is representative of the devices supplied by that distributor
Sampling method that is representative of the devices supplied by that distributor
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Some Related Topic Tags
distributors (medical devices), eu 2017/745, samples and sampling plans
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  Post Number #1  
Old 15th May 2018, 05:14 AM
dieperie

 
 
Total Posts: 3
Please Help! Sampling method that is representative of the devices supplied by that distributor

Dear all,

I am trying to fulfill/address the following requirement:

Regulation (EU) 2017/745 - Article 14(2) - General obligations of distributors

"In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor."

Does anyone in the community have suggestions ?

Kind regards,

Edgar

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  Post Number #2  
Old 15th May 2018, 07:58 AM
Mike S.

 
 
Total Posts: 2,242
Re: Sampling method that is representative of the devices supplied by that distributo

What you have posted is a vague requirement. Is there no further guidance anywhere?

If not, you have to decide (and perhaps defend) what you would determine to be a representative sample. I don’t know your products, lot sizes, and what kind of variation you might expect to find in a lot, or the risks associated with not finding “excessive” variation if it exists.

Maybe a discussion with your co-workers and/or customer or peer companies would give you some ideas.
  Post Number #3  
Old 15th May 2018, 09:59 AM
dieperie

 
 
Total Posts: 3
Re: Sampling method that is representative of the devices supplied by that distributo

The concern I have is with the following :

Before making a device available on the market, distributors shall verify that all of the following requirements are met:
(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
(b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
(d) that, where applicable, a UDI has been assigned by the manufacturer.

One would say you verify these elements once before making available on the market. We are not debating about the Q&C, but QA aspect of product.

Methodology
The sample should be partly selective based on the factors set out above and partly nonselective, and should result in a representative range of different products being selected, without excluding the random element of sampling.

Any ideas?




  Post Number #4  
Old 17th May 2018, 08:03 AM
Mike S.

 
 
Total Posts: 2,242
Re: Sampling method that is representative of the devices supplied by that distributo

Sounds like you would randomly select 1 or more Type A devices, 1 or more Type B devices, 1 or more Type C devices, etc. to satisfy the randomness requirement but also ensure that each Type of device is selected.
  Post Number #5  
Old 17th May 2018, 09:56 AM
dieperie

 
 
Total Posts: 3
Re: Sampling method that is representative of the devices supplied by that distributo

You are correct. The question is how to determine and track --> sampling plan.
  Post Number #6  
Old 17th May 2018, 10:41 AM
Statistical Steven's Avatar
Statistical Steven

 
 
Total Posts: 1,123
Re: Sampling method that is representative of the devices supplied by that distributo

Quote:
In Reply to Parent Post by dieperie View Post

You are correct. The question is how to determine and track --> sampling plan.
The requirement seems to imply that a statistically sound sampling plan can be used to show that the requirement has been met without the need for 100% sampling. Any sampling plan should be based on the risks associated with failure to meet the acceptance criteria. In other words, you need to select a sampling plan that is commensurate with risk.
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