EU Commission Updates Guidance on SARS-CoV-2 Test Classification

The In Vitro Diagnostic (IVD) expert panel of the European Commission has released new scientific advice regarding SARS-CoV-2. The panel notes that, while the virus can still cause serious illness, it no longer poses a life-threatening risk with a significant mortality rate for the general European population.

This updated assessment may influence the classification of SARS-CoV-2 tests under Regulation (EU) 2017/746. Manufacturers are encouraged to:

• Evaluate how this advice impacts their devices.
• Consult with their notified bodies to determine necessary conformity assessment steps if a change in risk class is warranted.

In the interim, devices can continue to be marketed under their current risk classification, provided they meet all necessary requirements for that class, such as batch testing in accordance with Article 100(2)(b) of Regulation (EU) 2017/746.

The Medical Device Coordination Group (MDCG) is updating its guidance on IVD classification (MDCG 2020-16) to reflect this new advice. It's important to note that both the expert panel's advice and the MDCG classification guidance are not legally binding. Manufacturers should determine each device's risk classification on a case-by-case basis, considering the device’s intended purpose and target population. Additionally, the panel's advice pertains to the current epidemiological context, and manufacturers should consider any changes in this context when evaluating the classification of their tests.

For detailed information, please refer to the official announcement: https://health.ec.europa.eu

MedNet EC-REP GmbH remains committed to keeping our clients informed about regulatory updates that may impact their products. We encourage manufacturers to review this new guidance and assess its implications for their devices.