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
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