EU MDR - Annex II 6.1 Pre-clinical and clinical data

Cybel

Involved In Discussions
#1
Hi
I’m working on the technical documentation for MDR and I'm struggling on the par. 6.1 of Annex II, in particular in my mind the par. 6.1(a) and 6.1(b) are partially overlapped and I cannot well decide what falls under the paragraph (a) and under the paragraph (b).
Schermata 2021-01-12 alle 12.58.54.png
In my understanding:
- par. 6.1(a) considers all the pre-clinical tests made on the product, except the ones related to the list in par. 6.1(b). For these tests, it is enough to provide the results only
- for the tests listed in par. 6.1(b) it is necessary to provide protocols, methods, data summaries and results as well

Is it so?

Should I provide test protocol and methods also for test made by an external laboratory (for example for Electromagnetic compatibility)? More generally, if we don’t make tests inside, how should I get information about test protocol? Following the technical standard is not the test protocol itself? Provide the test report issued by the laboratory isn’t enough?

Thank you in advance
 

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planB

Super Moderator
#2
Cybel,

a little bit different: par. 6.1 (a) generally tells you to compile any data that demonstrate pre-clinical safety and conformity to its specification; par. 6.1 (b) is more specific and tells you that in all cases these data _must_ include biocompatibility (if in body contact), the device's relevant physico-chemical properties, including its microbial state (if applicable, e.g. sterility) and electrical safety information (if applicable).

For any performed test, there should be a protocol upfront (regardless whether the test is performed directly by you or outsourced) and a related report upon completion of the test. For any outsourced test, you may want to ask the lab to provide you protocol(s) for review (and approval) prior to starting a test.

Hope this helps,
 

Cybel

Involved In Discussions
#3
Thanks PlanB
So, would you include under the par. 6.1(a) all the test results including biocompatibility, electrical safety, and so on and under 6.1(b) would you detail that parts in particular?

When we make a test inside the company we write a protocol, but I’ve never asked for a protocol to external laboratories :-(, when I require a test there is a discussion about how to proceed, of course, and some written documents about test construction, but nothing as detailed as a protocol… :-(
Could you maybe share an index of such a protocol? I would like to understand what is the detail level required for this.
 

planB

Super Moderator
#4
Cybel,

you may want to present references to your data as part of your GSPR checklist.

A test protocol should to a minimum contain scope and purpose of the planned test, description of samples and their justification (including sample size), description of test method and its justification, test parameters and their acceptance criteria. The level of detail should be adequate to allow trained test personnel to unambiguouly and reproducibly perform all planned test activities.

Specifically for (outsourced) biocompatibility tests you may want to request test(s) to be performed under GLP. Thus, the contracted lab will provide you with test protocol(s) to review.

Hope this helps,
 
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