IAF Accreditation and CE Mark Questions

Paul Simpson

Trusted Information Resource
#11
I didn't say that.
I just highlighted that there is no such explicit requirement in the MDD itself. I thought that this is what you asked.
I'm not involved enough in the intricacies of accreditation schemes to take one side or the other. I was hoping that the UKAS webpage would quickly clarify it but as I noted medical devices aren't among the fields explicitly listed there. Perhaps there are clear answers somewhere else but I don't currently have the time to chase them. Hopefully someone more involved could quickly point out an appropriate reference.

Sorry,
Ronen.
Darn, I was trying to keep this high level and generic. :D In the UK it is the MHRA who appoints MDD Notified Bodies - they provide a lot of guidance on the processes they are accountable for here. The conformity assessment process itself is outlined here.

Specific guidance for UK Notified Bodies is here.

The relevant section on conformity assessment is (IMHO) Section 5 - Facilities and it says:
(A) Extent
The notified body shall have available the appropriate facilities to enable it to carry out the assessment and verification activities for which it has been notified.
With further guidance:
The facilities should enable the notified body to perform the technical and administration tasks connected with evaluation and verification, whether those tasks are carried out by the notified body itself or under its responsibility (see also section 8). If verification and testing procedures require use of technical equipment normally controlled and used by the manufacturer, the notified body should be able to demonstrate that it both had access to, and full control of, the equipment during the relevant procedures.
IMHO it is the NoBo who has responsibility for ensuring testing complies with the MDD and European standards and that they would not accept testing carried out by a test laboratory (at the manufacturer's request) who is not accredited.

Section 8 provides further guidance on the NoBo's use of subcontractors. I don't believe that addresses the case Michelle has raised here.

Hope this helps.
 
Elsmar Forum Sponsor
#12
I have used test houses that do not have 17025 accreditation. Sometimes for convenience, sometimes because I could not find an accredited test facility.

This included the time when the device was an active implantable, which has much the same regulatory requirement that an EU Class III device does. So that means formal review of the Design File by your Notified Body.

The various test reports examined included one from a test lab that, although accredited for a range of tests, was outside their scope of accreditation. The NB auditor commented on this, saying that he might have to have the report further scrutinised or might even require an audit of the test house. As it was, the report was accepted with no further action.

I have also been involved in "in house" test programmes where we have conducted testing to EN60601-1, with no outside agency involvement. Our test facilities are not accredited. Our NB has accepted our test reports, although they are now subject to additional scrutiny by an accredited test house. (The test house examines our test report).

So - can you use a non-accredited test house?
Yes - but it may involve additional scrutiny before your NB will accept the report.
And similar difficulties may occur when trying to enter other world markets.
 

Ronen E

Problem Solver
Staff member
Moderator
#13
Darn, I was trying to keep this high level and generic. :D In the UK it is the MHRA who appoints MDD Notified Bodies - they provide a lot of guidance on the processes they are accountable for here. The conformity assessment process itself is outlined here.

Specific guidance for UK Notified Bodies is here.

The relevant section on conformity assessment is (IMHO) Section 5 - Facilities and it says:


With further guidance:


IMHO it is the NoBo who has responsibility for ensuring testing complies with the MDD and European standards and that they would not accept testing carried out by a test laboratory (at the manufacturer's request) who is not accredited.

Section 8 provides further guidance on the NoBo's use of subcontractors. I don't believe that addresses the case Michelle has raised here.

Hope this helps.
I appreciate the effort, but coming from the medical devices field I don't see anything new to me up to where you noted "IMHO". And, I appreciate it that you noted "IMHO", because at this point I'm yet to see some hard requirement for IAF accreditation (I'm not saying that there isn't, only that it's not that apparent, at least to me).
 

Marcelo

Inactive Registered Visitor
#14
As far I know,there's no requirement nor expectation that a test is traceable to anything (also, there seems to be a misunderstanding here, because the IAF is not related to accreditation of laboratories. ILAC, IAAC, EA, CB-SCHEME are the correct traceability for laboratory accreditation).

This is because testing is usually part of the verification activities of medical device design, and, as the other activities, is a responsibility of the manufacturer. He can perform all testing in house if he wants (and several manufacturers do).

The need for traceability to an accreditation scheme is usually more related to certification, which is, most of the time, a commercial need (not a regulatory one). Only a few medical device regulations worldwide do require some type of certification together with regulatory requirements. Brazil is one on them, and for some devices, you need to follow a certification scheme, and only use accredited labs.

On the other hand, please note that, due to some (wrong?) views, people seem to perceive aa test from a accredited lab to be more "confident" than one performed in house.
 
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Paul Simpson

Trusted Information Resource
#15
As far I know,there's no requirement nor expectation that a test is traceable to anything (also, there seems to be a misunderstanding here, because the IAF is not related to accreditation of laboratories. ILAC, IAAC, EA, CB-SCHEME are the correct traceability for laboratory accreditation).

This is because testing is usually part of the verification activities of medical device design, and, as the other activities, is a responsibility of the manufacturer. He can perform all testing in house if he wants (and several manufacturers do).

The need for traceability to an accreditation scheme is usually more related to certification, which is, most of the time, a commercial need (not a regulatory one). Only a few medical device regulations worldwide do require some type of certification together with regulatory requirements. Brazil is one on them, and for some devices, you need to follow a certification scheme, and only use accredited labs.

On the other hand, please note that, due to some (wrong?) views, people seem to perceive aa test from a accredited lab to be more "confident" than one performed in house.
I appreciate the effort, but coming from the medical devices field I don't see anything new to me up to where you noted "IMHO". And, I appreciate it that you noted "IMHO", because at this point I'm yet to see some hard requirement for IAF accreditation (I'm not saying that there isn't, only that it's not that apparent, at least to me).
Sorry it has taken a while but I was waiting for a reply from the UK Regulator, the MHRA, who accredit Notified bodies here. Their reply is that they expect Notified Bodies to use accredited laboratories or similar to provide confidence in the testing.

If the manufacturer is using an external laboratory then the expectation is that the testing will be equivalent for a Notified Body to be able to rely on it.

Hope this helps.
 

Paul Simpson

Trusted Information Resource
#17
My pleasure. People helping people, right? :)

Please bear in mind this position has come from the UK Regulator - other EU Regulators should use equivalent systems.


What does "similar" mean in that context?
So the exact quote is:
I can confirm that manufacturers of medical devices are expected to use accredited laboratories or similar when subcontracting any testing of their products. Any internal testing performed should be done under their own certified Quality System.
My question was about use of accredited laboratories and I sent a link back to this thread. I can try going back with further questions but can't guarantee a response that will answer all possible questions. We have to put this in the context of the original thread and that is use of unaccredited laboratories.


Equivalent with what?
So back to my interpretations. The regulator seems to expect manufacturers to use accredited testing labs. This expectation should be taken on board by any Notified Bodies the accreditation body notifies to the EU and the NoBo should pass on this expectation to manufacturers it certifies under the Directive / standard.

The 'wiggle room' is in the 'or similar' but it remains down to the manufacturer to satisfy the NoBo and for the NoBo to satisfy the MHRA that systems are equivalent.

IMHO that would be a lot of work if you use an unaccredited lab for all bar the simplest of tests.

Hope this helps.
 

Marcelo

Inactive Registered Visitor
#18
Please bear in mind this position has come from the UK Regulator - other EU Regulators should use equivalent systems.
The regulator seems to expect manufacturers to use accredited testing labs. This expectation should be taken on board by any Notified Bodies the accreditation body notifies to the EU and the NoBo should pass on this expectation to manufacturers it certifies under the Directive / standard.
Unfortunatelly, or fortunatelly, people in a high regulated environment cannot and do not act only on positions or expectations, but on what is explicitly written as requirements. And it's still no requirements in the applicable directives to use accredited laboratories.

Also, although each country can have additional requirements than what is required in the directives, they cannot contradict the directives, and this would be a case like this.

IMHO that would be a lot of work if you use an unaccredited lab for all bar the simplest of tests.
Not a all. I've seen hundreds of cases in which unaccredited laboratories are used, or, which is more common, tests are performed in house.
 

Ronen E

Problem Solver
Staff member
Moderator
#19
My pleasure. People helping people, right? :)

Please bear in mind this position has come from the UK Regulator - other EU Regulators should use equivalent systems.


So the exact quote is:

My question was about use of accredited laboratories and I sent a link back to this thread. I can try going back with further questions but can't guarantee a response that will answer all possible questions. We have to put this in the context of the original thread and that is use of unaccredited laboratories.


So back to my interpretations. The regulator seems to expect manufacturers to use accredited testing labs. This expectation should be taken on board by any Notified Bodies the accreditation body notifies to the EU and the NoBo should pass on this expectation to manufacturers it certifies under the Directive / standard.

The 'wiggle room' is in the 'or similar' but it remains down to the manufacturer to satisfy the NoBo and for the NoBo to satisfy the MHRA that systems are equivalent.

IMHO that would be a lot of work if you use an unaccredited lab for all bar the simplest of tests.

Hope this helps.
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?...
 

Paul Simpson

Trusted Information Resource
#20
<snip>Darn, I was trying to keep this high level and generic. :D </snip>
<snip>IMHO it is the NoBo who has responsibility for ensuring testing complies with the MDD and European standards and that they would not accept testing carried out by a test laboratory (at the manufacturer's request) who is not accredited.

Section 8 provides further guidance on the NoBo's use of subcontractors. I don't believe that addresses the case Michelle has raised here.</snip>
Maybe I should have known this would get into the weeds real quick. I had a bit of an assumption that on this thread some of the Directives requirements and process for notification could be taken as read. :nope:

The specific question was about the use of a test facility that is unaccredited and that is what I have been responding to.


Unfortunatelly, or fortunatelly, people in a high regulated environment cannot and do not act only on positions or expectations, but on what is explicitly written as requirements. And it's still no requirements in the applicable directives to use accredited laboratories.
The requirement in the common framework directive is for the notified body to ensure that any conformity assessment is suitable. I've given you the competent authority's view on what is suitable testing for UK NoBos. If you disagree perhaps you can post a link to other country's guidance where use of unaccredited laboratories is allowed?


Also, although each country can have additional requirements than what is required in the directives, they cannot contradict the directives, and this would be a case like this.
I disagree. It is the competent authority's responsibility to decide what is appropriate for the NoBo. The 2008 Directive has taken out reference to the EN 45xxx series of standards (probably so as not to conflict with WTO requirements). Notification is an EU activity and I assume all EU competent authorities will apply similar standards to the one for the UK that I have described.

Not a all. I've seen hundreds of cases in which unaccredited laboratories are used, or, which is more common, tests are performed in house.
Perhaps you can PM me some unaccredited laboratory examples that you have been involved with and I'll test them out with a competent authority.

In house testing is not in dispute, the NoBo has the opportunity to ensure that testing is carried out with equivalent systems to an accredited laboratory. The OP was about the use of an ASCB (E) 'accredited' laboratory - not recognized under the EU Regulations.
 
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