Change Notification - Registrar vs Notified body

[Racky]

Hi All,

We have an ISO 13485 certificate for sub-component manufacturing issued by a notified body (A; Registrar in this case), whereas the FQA and EC certificate for class III device is issued by another notified body (B) for the finished device. The FQA contains the sub-component manufacturing site listed and the Notified body B has also issued us the ISO 13485 cert for the finished device manufacturing site. We did a substantial manufacturing process change at the sub-component manufacturing site (ISO 13485 cert issued by Notified body A). However, this was a not a quality system change and falls under Annex II, Section 4.4. We notified the substantial change to notified body B since they issued us the EC certificate and FQA.

DO we need to notify this change to the registrar (Notified body A) as well ? They have not issued us a EC cert or FQA.

Thanks

 

[Jen Kirley]

Hi All,

We have an ISO 13485 certificate for sub-component manufacturing issued by a notified body (A; Registrar in this case), whereas the FQA and EC certificate for class III device is issued by another notified body (B) for the finished device. The FQA contains the sub-component manufacturing site listed and the Notified body B has also issued us the ISO 13485 cert for the finished device manufacturing site. We did a substantial manufacturing process change at the sub-component manufacturing site (ISO 13485 cert issued by Notified body A). However, this was a not a quality system change and falls under Annex II, Section 4.4. We notified the substantial change to notified body B since they issued us the EC certificate and FQA.

DO we need to notify this change to the registrar (Notified body A) as well ? They have not issued us a EC cert or FQA.

Thanks

Good day Racky, I am sorry for the delay in this response.

Can you please describe your "substantial manufacturing process change at the sub-component manufacturing site" and why you feel it is not quality system change? Is your sub-component manufacturing site included in your main certificate as a support site?

This is a question for your registrar, who would have a contract with you that likely includes terms of when you would be required to notifiy them of changes.