MDR Technical Documentation review

[Pale Pilgrim]

Hi,

I am working on submitting the technical documentation for a class IIa device to our notified body (BSI) for review. Has anyone here gone through the review process yet? In the rounds of questions during the review process did you think there were any areas that they were more interested in? Were their questions quite specific or broad in scope? Just trying to get a feel for what to expect once the submission goes in!

 

[shimonv]

That's a very broad questions...
- The notified bodies are very bureaucratic in nature, so they will review everything.
- Usually there is more than one reviewer; special attention will be given to areas where they are most comfortable with.
- The nonconformists should be very specific so you can address them appropriately.


Good luck.
Shimon

 

[Pale Pilgrim]

Thanks for the reply Shimon and for the well wishes.
I know its a broad question and they will review everything submitted but sometimes a question that was asked of another company or another companies experience of the the process might trigger you to consider something a bit differently. Really I'm just trying to get a feel for peoples experience of the review process to help with my own thought process.

 

[Philip B]

BSi will be very thorough and specific. Some examples from our experience:
1. Bill of materials for all device variants.
2. Supplier details and materials of construction for all components.
3. All promotional materials to be up to date, citing correct standards and CE marks.
4. Devices to be tested against the performance requirements of all applicable harmonised standards. Testing to include worst case sterilisation dose and to the end of device life.
5. In-process inspection procedures, examples of batch inspection.
6. Details of procedures for accepting purchased materials.
7. Clear links between risk and standards.

And many more. MDR is a step-change from MDD, not only in the reg itself but also the rigor and extent of NB reviews.

Expect a lot of questions in round one and hopefully most of these will be clarifications or things easily rectified.

Good luck.

 

[Pale Pilgrim]

Thanks Phillip. I reckon our technical documentation will be in pretty good shape when we submit, but its always good to hear about others experiences to get a feel for what to expect once the submission goes in.