Standards used for Medical Device MDD Technical Files

D

Dosumi

#21
We are not the manufacturer of the materials being tested, we use these materials on our products, cover materials and handle grips etc.

These are used on class1 medical devices and we do the testing as our suppliers do not test to these requirements.

I will have to research more to see if there is some type of time requirement in MDD 93/42 EEC

thanks
 
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Ronen E

Problem Solver
Staff member
Moderator
#22
I will have to research more to see if there is some type of time requirement in MDD 93/42 EEC
I'll save you the trouble. There isn't any. The requirements for class I are very limited and honestly, the more you elaborate the less I understand your situation and how you came to be in it.

Sorry,
Ronen.
 
D

Dosumi

#23
To apply for a European government contract to supply our products it needed to be tested to and meet the requirements of EN12182.
We are using a internationally recognized test laboratory in Germany. The last time we tested these materials was in late 2011 to early 2012, those test reports were submitted and later rejected due to being over 3 years old?

I am/was trying to find out if in fact there is such a rule (in Europe)that reports expire after 3 years, it is not stated in EN12182 or any of the other standards I looked into?

Also our class 1 products are not exempt from US 510k requirements and have to meet MDD 93/42 class 1 medical device requirements. Even though as class 1 you can self certify , when you submit to government agencies you have to have certifications from accredited test facilities. There are specific ISO and EN standards that have to be meet, EN12812 and or 12183 and ISO 7176 series.

In this case it is not a big deal as both products use the same materials, but retesting of all products including subsequent bio and flammability testing every 3 year could get very expensive. If there has been no change to a standard or to the product that would affect the safety or intended use of a product I don't see the need to retest only because of an arbitrary 3 year time period that someone set.

But thanks for the feedback
Don
 
Last edited by a moderator:

pkost

Trusted Information Resource
#24
From your last post it appears that it is the government tender that is requiring a retest after 3 years, not a test house.

If the tender says the report must be no older than 3 years, then it must be no older than 3 years, because that is what your customer wants (they just happen to be a government). The directive in this case is irrelevant.

If you were dealing with a small customer I would say that you may be able to convince them why their requirement is inappropriate/unnecessary, however, from experience with government tenders, you are unlikely to be successful in this regard.

MDD 93/42/eec defines the responsibilities and obligations of a manufacturer who want to place product on the market - i.e. offer it for sale in Europe. It is important to note that it does not define responsibilities or obligations of purchasers.
 

Ronen E

Problem Solver
Staff member
Moderator
#25
From your last post it appears that it is the government tender that is requiring a retest after 3 years, not a test house.

If the tender says the report must be no older than 3 years, then it must be no older than 3 years, because that is what your customer wants (they just happen to be a government). The directive in this case is irrelevant.

If you were dealing with a small customer I would say that you may be able to convince them why their requirement is inappropriate/unnecessary, however, from experience with government tenders, you are unlikely to be successful in this regard.

MDD 93/42/eec defines the responsibilities and obligations of a manufacturer who want to place product on the market - i.e. offer it for sale in Europe. It is important to note that it does not define responsibilities or obligations of purchasers.
Spot On!!!

:applause:
 
D

Dosumi

#26
it has nothing to do with the tender country, it is as I stated before the testing house certifying body required them to limit accepting test reports older than 3 years.
The test facility is only supplying us with the test report to EN12182 they are not dealing directly with the tender country, that is done by us and is a different country than where the test facility is.

When this process is over I will inquire more with the testing house about who is requiring them to limit reports to 3 years and where they are getting the authority to impose this on the certification of testing facilities.

Thanks
 
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