IAF Accreditation and CE Mark Questions

Remus

Involved In Discussions
#21
NBs have to verify every information on technical file. (It is written somewhere...)
Accreditation certificate of a test report means that some government institute is controlled that test reports laboratory ability to perform that test.
So, if your product tests are carried out on a non-accredited laboratory, your NB have to audit that laboratory for its ability to perform that test...
Just use accredited laboratories or build your in-house laboratory.
And don't forget NB's simply don't have resource to verify everything.
 
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Paul Simpson

Trusted Information Resource
#22
Thanks for trying to clarify but I still find it highly confusing. I do understand that you are not the source of that confusion and only relaying the MHRA's response. My rant is against them if indeed that's the best they could provide. To me it sounds like they are trying to raise the bar more than necessary, and they know that they are a bit shaky with the directive so they are trying to say what they want to say while not fully saying it... :confused::)

To me, either you're allowed to use a non-accredited lab, or you're not. There's no middle ground here. How can a non-accredited lab be "similar" to an accredited one while not actually being accredited?... Definitely they're not similar in the accreditation aspect. And if what really matters to the MHRA is not the accreditation itself but other aspects (in which the non-accredited and accredited labs can be similar) - why not state what these aspects are?...

Same about being "equivalent". How is that decided or even argued?...
Sorry I missed this, Ronen. I think our posts crossed. Again I have to emphasize these are my views and not those of the competent authority. There is some clarity emerging, I think.
  • The contact at MHRA has said that NoBos they assess should be looking for accreditation for measurements and testing carried out in support of approval of a medical device.
  • Where the manufacturer doesn't use accreditation to provide assurance to the NoBo then it is the NoBos responsibility to ensure the controls are effective - equivalent to accredited testing
  • As Marcelo has mentioned there is a long history of 'in house' testing in support of a device approval. This should be supported by test methods and calibrated equipment - similar to an accredited laboratory (17025)
  • Where testing is carried out by an unaccredited test laboratory it is still the NoBo's responsibility to see that testing is equivalent by checking the laboratory has the same level of control of test methods and equipment.

As I mentioned in my most recent post, I believe the Directive's reference to the EN 45xxx series of standards was taken out so as not to be prescriptive. IMHO the IAF / ILAC guidance should be revised and make this clear that ISO / IEC 17xxx is a way of demonstrating effective testing and conformity assessment but that other means are acceptable if seen to be equivalent.
 

Ronen E

Problem Solver
Staff member
Moderator
#23
Thanks, though some parts are still cryptic to me.

[...] 'in house' testing [...] should be supported by test methods and calibrated equipment - similar to an accredited laboratory (17025)
Are you / the MHRA suggesting now that manufacturers should follow 17025 (if not to the letter, then in essence) in order for their in-house testing to be considered acceptable? Isn't that a little far-reaching? Certainly the MDD doesn't require that or imply that.

I believe the Directive's reference to the EN 45xxx series of standards was taken out so as not to be prescriptive.
This is completely unclear to me. By "the Directive" are you referring to the MDD? As far as I know it never referred to the EN 45xxx series directly; all MDD references to standards are through OJ publication in the harmonized standards list, and this kind of reference can't be "prescriptive" because the application of harmonized standards (or any standards, for that matter) is voluntary in the MDD context.
 

Paul Simpson

Trusted Information Resource
#24
OK, Ronen. I'm out of here. I don't have time to put everything into every post I put up here. As I mentioned earlier the MDD relies on a number of other conformity assessment directives to give it teeth.

Those directives describe the conformity assessment modules to be applied and the management system requirements.
 

Ronen E

Problem Solver
Staff member
Moderator
#25
OK, Ronen. I'm out of here. I don't have time to put everything into every post I put up here. As I mentioned earlier the MDD relies on a number of other conformity assessment directives to give it teeth.

Those directives describe the conformity assessment modules to be applied and the management system requirements.
Fair enough.

I'll try to summarise the "take away" from this thread in the OP context, as I currently understand things:

--> Utilising accredited labs is the path preferred by the MHRA (and thus UK MDD NBs) - it is the least likely to raise questions or require additional resources.

--> Utilising non-accredited labs is still permitted, however there's a risk to the manufacturer that the (UK) NB will insist on ascertaining that that lab has quality assurance controls equivalent to ISO 17025 (?) I can only guess who'll need to absorb the additional costs... :notme:

--> In-house testing is acceptable as long as the auditing (UK) NB is happy with implemented relevant controls (in most cases they will audit the manufacturer's QMS anyway).

Anyone unhappy with my interpretation is very welcome to challenge it. :)

Cheers,
Ronen.
 
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