Updates to Technical Documentation

[Philip B]

We submitted our technical documentation for assessment to the MDR back in August and are still awaiting the review. We've been told by our NB that we can't make changes to the TD in the meantime. However, TD is a live thing and regular updates are necessary and we have several updates to make (updated VMP, CER etc). I've ended up with with two parallel TD files, one frozen since August and a live one I am updating. I wondered how others have handled this?

 

[engemerson]

you cannot make changes while you are under review by the NB, only after approval you could make the appropriate change, submit the technical documentation for review with the NB after approval, you can disclose it.
the structure of your documentation has to be like this:
3 folders (example)
FOLDER 1: CURRENT TECHNICAL FILE
FOLDER 2: TECHNICAL FILE AWAITING NB APPROVAL
FOLDER 3: OBSOLETE TECHNICAL FILE

no modifications can be made while transitioning from MDD 93/42 to MDR 745
see article 120 of MDR 745

 

[Philip B]

I've just re-read article 120 and it doesn't mention anything to do with the question I asked.

Five months (and counting) is a long time to keep your technical file frozen, we make regular updates normally (not to major things like intended use or design of course). Keeping your file updated seems to me to be a key regulatory and QMS requirement and I worry this will be a 'damned if you do, damned if you don't' NB situation.

 

[engemerson]

durante o processo de transição, não pode haver mudanças significativas que possam alterar o design, a indicação, o uso pretendido ou a finalidade.
no entanto, as atualizações devem ser baseadas no MDD, pois você não pode fazer a avaliação de conformidade da alteração com base no MDR, pois ainda não possui o certificado MDR.
ajustes como revisões de normas, nomenclaturas de gêneros podem ser atualizados, mas aconselho que informe seu RN sobre a mudança.
tivemos uma auditoria para a transição do MDD para o MDR e tudo isso foi apontado como não conformidade, pois fiz alterações na documentação técnica e enviei para análise, e tenho que ter dois documentos técnicos:
a corrente com base no MDD revisado
ou em processo de revisão com base no MDR.
veja este link abaixo.

https://www.advenamedical.com/authorised-representative/mdr-article-120-transitional-provisions/

 

[twanmul]

Translated for those who are too lazy

during the transition process, there can be no significant changes that may alter the design, indication, intended use, or purpose. however, updates must be MDD-based because you cannot do the mdr-based change compliance assessment because you do not already have the MDR certificate. adjustments such as revisions of standards, gender nomenclatures can be updated, but I advise you to inform your RN about the change. we had an audit for the transition from MDD to MDR and all this was pointed out as non-compliance, because I made changes in the technical documentation and sent it for analysis, and I have to have two technical documents: the current based on the revised MDD review process based on the MDR. see this link below.

From my experience, we have a "changes required log" in our QMS allocated to specific technical document references and a dedicated change window for our Technical Documentation to be updated and issued (kind of like the football player transfer window, just for these document change requests to be included in). This means that we spend less time on a routine basis updating our documentation for routine or minor changes and have the flexibility to be able to update if there is something really important or high risk that needs incorporating into the TD. This does take some quite detailed reconciliation when it comes to updating but does prevent the specific issue you've got here.

 

[engemerson]

Translated for those who are too lazy


From my experience, we have a "changes required log" in our QMS allocated to specific technical document references and a dedicated change window for our Technical Documentation to be updated and issued (kind of like the football player transfer window, just for these document change requests to be included in). This means that we spend less time on a routine basis updating our documentation for routine or minor changes and have the flexibility to be able to update if there is something really important or high risk that needs incorporating into the TD. This does take some quite detailed reconciliation when it comes to updating but does prevent the specific issue you've got here.

Your analysis is correct about the updates.
there are two areas, the current MDD according to the validity period of the certified seru, and the other area is to review the documentation in compliance with the requirements of the MDR.
what has to be described in your procedures that significant changes must be communicated to your notified body (NB) and detail in the procedure what are significant changes.
the rest of the updates that are necessary, carry out as determined by the documentation of your QMS.
this conformity assessment will be reviewed by the auditor when performing a transition and monitoring audit.

 

[Philip B]

Translated for those who are too lazy


From my experience, we have a "changes required log" in our QMS allocated to specific technical document references and a dedicated change window for our Technical Documentation to be updated and issued (kind of like the football player transfer window, just for these document change requests to be included in). This means that we spend less time on a routine basis updating our documentation for routine or minor changes and have the flexibility to be able to update if there is something really important or high risk that needs incorporating into the TD. This does take some quite detailed reconciliation when it comes to updating but does prevent the specific issue you've got here.

Thanks Twanmul

 

[Ed Panek]

This is similar I imagine to any regulatory dossier under review.

For any regulatory submission, it's expected that changes to details will occur. The question is how does it meet MDCG or FDA guidance on a substantial change. If mid review a major change is made I think the submission planning was not done well or something unpleasant happened..

I suggest you have a benchmark dossier that represents the actual approval conditions. From there letters or memos to file regarding small incremental changes to bring it up to speed. We made it a habit for EVERY change to device or QMS I write a memo comparing the change to the MDD/MDR and FDA guidance and the rationale why it doesn't require regulatory re-approval. We also discuss cumulative changes over the year at Management Review and why we will or will not alert FDA or EU about them.