Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

A manufacturer currently has a software IVD device on the market in the EU that does not require a CE mark under the IVDD.  If the device is elevated to Class C device under the IVDR, it is clear the manufacturer must have the device to pass NB review to CE mark after May 2020. 

However, if the manufacturer does not wish to complete NB review and stops offering the product for sale prior to May 2020, can the manufacturer continue to "support" existing installations of the software placed on the market before the deadline? Support would mean bug fixes/security enhancements but no new functionality and no change to intended use. Would vigilance/post market surveillance of the product be required?  Thanks.

The date for the IVDR is May 2022, not May 2020.

If the device doesn't have a CE Mark under the IVDR, then those requirements do not apply.

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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 13-Nov-2019 16:06
From: Anonymous Member
Subject: Post Market Surveillance under IVDR

This message was posted by a user wishing to remain anonymous

A manufacturer currently has a software IVD device on the market in the EU that does not require a CE mark under the IVDD.  If the device is elevated to Class C device under the IVDR, it is clear the manufacturer must have the device to pass NB review to CE mark after May 2020.

However, if the manufacturer does not wish to complete NB review and stops offering the product for sale prior to May 2020, can the manufacturer continue to "support" existing installations of the software placed on the market before the deadline? Support would mean bug fixes/security enhancements but no new functionality and no change to intended use. Would vigilance/post market surveillance of the product be required?  Thanks.