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This message was posted by a user wishing to remain anonymous

For IVDR… will a Notified Bodies accept data/test records compliant to a current applicable CLSI document?  or does the cited Specification / Standard Reference (and data/record generated) need to be compliant to an EN or say ISO standard?
All comments appreciated.

I have used CLSI standards as part of the performance testing documentation in the Technical File for an old List B product that was accepted.  Under the EU MDR, not quite sure because there are going to be lots more performance testing reports being provided as part of Technical Documentation.  With that said, the CLSI standards does not really have any strong counter-part in the EU, there are a couple ISO standards.  Personally, I would/will be using the CLSI standards as part of performance testing of IVDs since they are well recognised and well-established standards to follow for analytical testing.  How Notified Bodies will accept them - it varies between Notified Bodies, so I would definitely have the conversation with your reviewer of technical documentation.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 12-Mar-2020 14:39
From: Anonymous Member
Subject: IVDR - Specification / Standard Reference

This message was posted by a user wishing to remain anonymous

For IVDR… will a Notified Bodies accept data/test records compliant to a current applicable CLSI document?  or does the cited Specification / Standard Reference (and data/record generated) need to be compliant to an EN or say ISO standard?
All comments appreciated.

This message was posted by a user wishing to remain anonymous

thank you Richard - great help!
Original Message:
Sent: 14-Mar-2020 10:18
From: Richard Vincins
Subject: IVDR - Specification / Standard Reference

I have used CLSI standards as part of the performance testing documentation in the Technical File for an old List B product that was accepted.  Under the EU MDR, not quite sure because there are going to be lots more performance testing reports being provided as part of Technical Documentation.  With that said, the CLSI standards does not really have any strong counter-part in the EU, there are a couple ISO standards.  Personally, I would/will be using the CLSI standards as part of performance testing of IVDs since they are well recognised and well-established standards to follow for analytical testing.  How Notified Bodies will accept them - it varies between Notified Bodies, so I would definitely have the conversation with your reviewer of technical documentation.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 12-Mar-2020 14:39
From: Anonymous Member
Subject: IVDR - Specification / Standard Reference

This message was posted by a user wishing to remain anonymous

For IVDR… will a Notified Bodies accept data/test records compliant to a current applicable CLSI document?  or does the cited Specification / Standard Reference (and data/record generated) need to be compliant to an EN or say ISO standard?
All comments appreciated.

With an increased emphasis on "state-of-the-art" we are seeing additional requests from Notified Bodies to show compliance with standards that are not harmonized. If the CLSI is the most appropriate standard I would not hesitate to use it to support the IVD. Of course, listing your rationale for that selection in the technical documentation will go a long way to support it.  ​

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Nancy Morrison RAC
Executive Director Regulatory and Quality Consulting Services
Monroeville PA
United States
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Original Message:
Sent: 12-Mar-2020 14:39
From: Anonymous Member
Subject: IVDR - Specification / Standard Reference

This message was posted by a user wishing to remain anonymous

For IVDR… will a Notified Bodies accept data/test records compliant to a current applicable CLSI document?  or does the cited Specification / Standard Reference (and data/record generated) need to be compliant to an EN or say ISO standard?
All comments appreciated.