Posted on

Updated classification for SARS CoV-2

Recently we saw Team-NB release a Position Paper on the Classification of devices intended to detect SARS-CoV-2. There has been a lot of discussion about whether SARS-CoV-2 IVDs should remain classified as a Class D under the requirement of detecting a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation. The Team-NB Position Paper is that this classification should be re-assessed based on the facts that there are effective vaccines available, currently no circulating variants of concerns and evidence that the current circulating variants within the EU indicate no increased impact on immunity or severity for the general population.

There are two possible re-classification routes that are suggested:

· Class B – under rule 6 – devices not covered by the other classification rules.

· Class C – under rule 3c – devices where there is a significant risk that an erroneous result would cause death or severe disability to the individual, foetus or embryo being tested, or to the individual’s offspring.

Team-NB’s position is that Class C should be recommended due to the potential remaining risk for vulnerable populations and the limited data available for the post-pandemic phase. This would also ensure that stricter PMS & Performance Evaluation/Clinical Evidence requirements are applied for these devices.

This could be welcome news to manufacturers of these devices. We will need to see if this leads to a change in the MDCG guidance – watch this space!


Written by Fiona Thompson – Regulatory specialist at IVDeology