Team Notified Body (NB) has proposed reclassifying SARS-CoV-2 IVD devices. You can find the full Position Paper: HERE

Background

SARS-CoV-2 devices are currently Class D devices, according to MDCG 2020-16 Rev. 2, per Rule 1, 2^nd indent (page 11). This is based on:

“Devices intended to be used for the detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation.”

Designation of “life-threatening” with a “high or suspected high risk of propagation” is determined by incidence, transmission, pathogenicity, mortality, and morbidity. This is based on a quantitative analysis of new scientific evidence for the relevant infectious agents.

Team NB states such a correlation could be demonstrated during the pandemic, which was caused by a “novel” pathogen. However, Team NB states that this designation may no longer be appropriate. For example, considering the WHO’s statement that:

“COVID-19 is now an established and ongoing health issue which no longer constitutes a public health emergency of international concern (PHEIC)”

Reclassification Recommendation

Team NB proposes an initial reclassification from Class D, to Class C.

The Class C designation is due to the remaining risk factors for vulnerable populations (worst-case scenario) and the limited amount of data available for the post-pandemic phase. A Class C designation would still enforce a high level of controls, e.g., stricter post-market and performance evaluation monitoring, and full technical documentation review of self-test or near-patient tests.

A reclassification to Class B may be appropriate in the future, once more data on the post-pandemic phase becomes available, e.g., on long COVID syndrome.

Please read the Position Paper for the full rationale and consequences of each possible reclassification scenario.

Consequences of Reclassification

This would mean that the 26 May 2025 deadline would no longer be applicable for manufacturers of IVDD legacy SARS-CoV-2 devices. Instead, it would be 26 May 2026.

Below are the current deadlines for IVDD legacy devices to comply with the IVDR, per Article 110’s transitional provisions.

Eventual IVDR Classification	Compliance Deadline (“IVDR Progressive Rollout”)
Class A non-sterile	26 May 2022 – No transition period granted; must comply immediately
Class A sterile	26 May 2027
Class B	26 May 2027
Class C	26 May 2026
Class D	26 May 2025

Moreover, considering the Commission’s proposal to further extend the IVDR deadline for legacy devices, this would mean manufacturers “only” need to 1) have lodged an application with a Notified Body by 26 May 2026, and 2) have signed an agreement by 26 September 2026. This would allow manufacturers more time to continue marketing their IVDD legacy device, while they work on IVDR certification.

Further, Class D devices are subject to higher controls, including validation of performance claims by an EU Reference Laboratory. Reduction to Class C would make the path to market more manageable for manufacturers – for both IVDD legacy devices and devices new to the market (which must immediately comply with the IVDR).

Further Reading

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