Verification Inspection Reports

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:

• EU MDR Article 15 Person responsible for regulatory requirement https://advisera.com/13485academy/mdr/person-responsible-for-regulatory-compliance/

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?

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.