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Verification Inspection Reports

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Guest user Created:   Oct 13, 2021 Last commented:   2h ago

Verification Inspection Reports

We have been asked by the PRRC to manage Verification Inspection Reports for each batch release - said QA Manager could not release a batch if this VIR document is not  signed off by the PRRC. I have searched MDR and did not find this document above.
My question is if this VIR exists, if yes if it is compulsory. If not, in what way PRRC is involved in batch release.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Oct 14, 2021

There is no direct requirement both in the MDR and ISO 13485 for the Verification inspection report. However, in the ISO 13485:2016, in requirement 8.2.6 Monitoring and measurement of the product, is stated that evidence of conformity to the acceptance criteria for each batch release must be maintained. What you call it, it is completely up to the manufacturer.

In Article 15 Person responsible for regulatory requirement, in point 3 is stated that PRRC shall be responsible for: The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.

How this conformity will be conducted in the company is up to the manufacturer. It can be called a Verification inspection report, and can be signed by the PRRC.

For more information, see:

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Guest user Oct 14, 2021

Thanks a lot for your detailed answer! I truly appreciate it.

May I ask for more help: do have you some idea on how as simple as possible PRRC can implement his role in batch release?

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Kristina Zvonar Brkić 2h ago

This probably depends most on whether the PRRC is within the company, in the same place where the batch release takes place, or is dislocated. If the PRRC is dislocated, one of the simpler ways is that batch release records can be sent to him via email and then he can confirm by email that he complies.

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Oct 13, 2021

Oct 18, 2021