Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello, 

Because there is much unknown about the Regulation, we would like our NB to review a Tech Documentation while preparing for a QMS audit under IVDR. However, the NB has rejected the application because they prefer quality audit before Tech Documentation review. 

The questions is whether we can try the "Type Examination & Production QMS" approach? Our understanding is that, in this case, the NB should agree reviewing the Tech Documentation. Quality audit should happen after issuing the Type Examination certification. 

Any thought on the approach is appreciated.

Thank you for sharing, because an interesting perspective as some Notified Bodies (NB) want to review technical documentation prior to conducting the QMS audit.  Personally, I could not say on the Type Examination because indeed we have had our technical documentation reviewed in advance prior to the QMS audit, but your NB may still do this differently.  Just keep in mind Type Examination & Production QMS, i.e. Annex X + XI under the EU IVDR will be much more burdensome than just going Annex IX.  Type examination may involve product testing, laboratory testing, and a much higher scrutiny on the production QMS.  (My own thought: more than likely they rejected your Technical Documentation review because they are not ready to conduct those yet.)

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 31-Jan-2020 18:29
From: Anonymous Member
Subject: Technical Documentation Review Under IVDR

This message was posted by a user wishing to remain anonymous

Hello,

Because there is much unknown about the Regulation, we would like our NB to review a Tech Documentation while preparing for a QMS audit under IVDR. However, the NB has rejected the application because they prefer quality audit before Tech Documentation review.

The questions is whether we can try the "Type Examination & Production QMS" approach? Our understanding is that, in this case, the NB should agree reviewing the Tech Documentation. Quality audit should happen after issuing the Type Examination certification.

Any thought on the approach is appreciated.