Annex II List A IVDs - Batch Verification Process

sreenu927

Quite Involved in Discussions
#1
Hi All,

I seek clarification on batch release of Annex II List A IVDs. From the IVD Directive 98/79/EC Annex IV, Section 6, I understood that the test reports of manufactured products or each batch of products must be forwarded (or made available) to notified bodies. Based on notified body's decision, the manufacturer may place the device on the market.

My question is - do we need to send the batch records (test reports) to a third party lab in EU and get a batch verification report before placing of products on market OR send to both Third Party and Notified Body OR only Notified Body?

Thanks,
Sreenu
 
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sreenu927

Quite Involved in Discussions
#3
I got the answer.

The responsibility of reviewing batch records lies with the Notified Body itself; however, most of the notified bodies sub contract this task to third party labs in EU. So notified bodies ask manufacturer to ship the products directly to that third party lab to do verification and provide a report to notified body. notified body, then issue the EC certificate to manufacturer.

Regards,
Sreenu
 
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