MDR & depth of technical files review by NB's

[renenatasha]

Think I found the difference in review of product documentation between IIa and IIb in Annex VII $4.5.3. Apparently for IIb a verification is needed, for IIa a confirmation is needed. I read this as for IIb the actual testing documentation will be reviewed, while for IIa the NB-review of a summary of testing is sufficient. What do you think?

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• establish a test plan identifying all relevant and critical parameters which need to be tested by the notified body or under its responsibility in order to:
• • — verify, for class IIb devices, the conformity of the device with the type described in the EU type-examination certificate and with the requirements of this Regulation which apply to those devices,
  • — confirm, for class IIa devices, the conformity with the technical documentation referred to in Annexes II and III and with the requirements of this Regulation which apply to those devices;

Did you check on the Conformity Assessment Procedure (CAP) as well? IIb actual testing is needed if you choose EU type-examination to be your CAP.
Have you decided which approach to take, @ralf90 ?

 

[ralf90]

Did you check on the Conformity Assessment Procedure (CAP) as well? IIb actual testing is needed if you choose EU type-examination to be your CAP.
Have you decided which approach to take, @ralf90 ?

The plan is to follow the equivalence of the MDD Annex II route, believe thats now Annex IX.

 

[RA_QA_Expert]

RA_QA Expert, based on your experience, do you mind sharing your thoughts on the followings?

1. Possible to combine Class I and Class Is in one TF if the MD shares the same intended use?
2. Should Technical Documentation be separated by Classification and/or Intended Use?

Design of our product is still the same, but it can be sterilized, right? I would recommend to have one technical documentation, but you must clearly describe what is for what class (e.g. in GSPR checkist).

 

[renenatasha]

Design of our product is still the same, but it can be sterilized, right? I would recommend to have one technical documentation, but you must clearly describe what is for what class (e.g. in GSPR checkist).

Yes - same design but classified as Class I n/s and Class Is.
Currently, under MDD, we have the same TF for both classification but recently, our NB clearly indicated that it needs to be separated; reason given is to avoid confusion to TF reviewer.

Thought?

 

[ralf90]

Yes - same design but classified as Class I n/s and Class Is.
Currently, under MDD, we have the same TF for both classification but recently, our NB clearly indicated that it needs to be separated; reason given is to avoid confusion to TF reviewer.

Thought?

I am curious what the reviewer exactly would be confused about. Without having done an exact check, I believe the reviewer is supposed to look at the sterilization part of the TF and not at the rest.

 

[renenatasha]

I am curious what the reviewer exactly would be confused about. Without having done an exact check, I believe the reviewer is supposed to look at the sterilization part of the TF and not at the rest.

I thought the same too but as informed by our NB, there is a possibility that TF will be reviewed; as opposed to what stated in Article 52 of EU MDR 2017/745.

The expectation is once a TF is requested for review, the reviewer should be able to clearly and promptly look up the information related, e.g. if we have our TF covering both Class I n/s and Class Is, it'll not be as easy and direct to look for pertaining info.

So, how do you compile your TF currently, @ralf90 ?

 

[ralf90]

Well, that sounds like a dilemma. I would still consider not to split it since the majority of the TF will just be a copy. In the long run there is the chance that differences will appear which do not make sense. What I saw in the past is that not the complete TF was handed to the NB in order to minimise chances of questions on parts which the NB is not supposed to ask questions about. In case questions arose one could first have a discussion on the need for the specific question.
For now I am not having this dilemma, all the current ones are class IIa. Here the plan is to have a summary of all testing in the main TF document and the elaboration on the testing in an annex. This in order to have the future choice of (not) initially providing those documents. This also to minimise the chance for questions which are 'out of scope'.

 

[renenatasha]

Well, that sounds like a dilemma. I would still consider not to split it since the majority of the TF will just be a copy. In the long run there is the chance that differences will appear which do not make sense. What I saw in the past is that not the complete TF was handed to the NB in order to minimise chances of questions on parts which the NB is not supposed to ask questions about. In case questions arose one could first have a discussion on the need for the specific question.
For now I am not having this dilemma, all the current ones are class IIa. Here the plan is to have a summary of all testing in the main TF document and the elaboration on the testing in an annex. This in order to have the future choice of (not) initially providing those documents. This also to minimise the chance for questions which are 'out of scope'.

Under the MDD, we don't have an issue but under the new MDR Annex II on Technical Documentation, we can't be selective in sharing info any longer. Our NB also quoted that the CA will possibly be looking into the TF triggered by vigilance, hence the TF should be as clear and easy to understand.

 

[ralf90]

Well, extra reason not no split the TF then I would say. It might become a complicated pile of paper if you would split.
My strategy would be to make the main TF (seemingly) very clear so reviewers will not be triggered to ask more questions. In that manner you can still have unclarities in the TF but they will not be noticed that quickly.
A bit like being very kind to the teacher in school and sit in the front of the class so the teacher will not see you as a potential cheater with exams....