MDR & depth of technical files review by NB's

ralf90

Starting to get Involved
#1
Dear all,

With the MDD there was a (clear) difference in the depth of review NB's did of technical files. A lot less detail for low risk, compared to high risk. E.g. for class Is only the specifics related to sterilisation.
Does someone know if the MDR tells something regarding this?

Regards,
Ralf
 
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Asia78

Involved In Discussions
#2
Hi ralf90,
For class Is, Ir and Im only the specific documents related to those procedures (sterilization, reprocessability...) are requested.
For all TDs of the other classes entire technical documentation has to be submitted.
 

ralf90

Starting to get Involved
#3
Hi Asia78,

That of class 1 makes sense, also the submission of the full TF. Does that also implicate that they will all be reviewed with the same level of detail? For as far as I know under MDD class IIa TF's were reviewed in less detail compared to high risk files. What do you think?
 

Asia78

Involved In Discussions
#4
Yes, at the moment we didn't see differences between the IIa and IIb, we send already more than one TD for both classes. The majority of the "more challenging" questions we recived were in the clinical part
 

Mikilk

Involved In Discussions
#5
Dear all,

With the MDD there was a (clear) difference in the depth of review NB's did of technical files. A lot less detail for low risk, compared to high risk. E.g. for class Is only the specifics related to sterilisation.
Does someone know if the MDR tells something regarding this?

Regards,
Ralf
For all classes of medical devices, manufacturers must now provide, as per Annex II, the information in the technical documentation to explain the design stages and procedures that applied to their device (this was significantly changed from MDD that required that design file will be included only in Class III). the main difference between classes is the dept required when dealing with the clinical evaluation report & with the PMS activities (a PMS plan that complies with the obligations of the manufacturers as referred to in Article 84 of the MDR, a Periodic Safety Update Report (PSUR) for devices greater than class I (Article 86 of MDR), or a PMS report for devices of class I (Article 85 of the MDR).
 

ralf90

Starting to get Involved
#6
For all classes of medical devices, manufacturers must now provide, as per Annex II, the information in the technical documentation to explain the design stages and procedures that applied to their device (this was significantly changed from MDD that required that design file will be included only in Class III). the main difference between classes is the dept required when dealing with the clinical evaluation report & with the PMS activities (a PMS plan that complies with the obligations of the manufacturers as referred to in Article 84 of the MDR, a Periodic Safety Update Report (PSUR) for devices greater than class I (Article 86 of MDR), or a PMS report for devices of class I (Article 85 of the MDR).
I read this that, besides Clinical and PMS, you presume there is no difference in depth of review of the TD between IIa and IIb. True? Or maybe formulated differently, it might be that the real depth of review might depend on which NB reviews documentation.
 

renenatasha

Involved In Discussions
#7
Dear all,

With the MDD there was a (clear) difference in the depth of review NB's did of technical files. A lot less detail for low risk, compared to high risk. E.g. for class Is only the specifics related to sterilisation.
Does someone know if the MDR tells something regarding this?

Regards,
Ralf
Have a look at Annex VII &
MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation (December 2019)
 

ralf90

Starting to get Involved
#8
Have a look at Annex VII &
MDCG 2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation (December 2019)
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?

+++
  • 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;
 

renenatasha

Involved In Discussions
#10
I have experience that notified body assessed full technical documentation also for Class Im, Is, Ir , although they should focus only on specific function.
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?
 
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