Update on COVID-19 Test Classification in the EU

The Medical Device Coordination Group (MDCG) Revises COVID-19 Test Classification

The Medical Device Coordination Group (MDCG) has revised the classification of COVID-19 tests following new scientific advice from an IVD expert panel. Initially, COVID-19 tests were classified as Class D due to the high risk posed by the SARS-CoV-2 virus. However, recent findings indicate that the virus no longer presents a life-threatening risk with a significant mortality rate for the general European population. As a result, the MDCG has updated its guidance, MDCG 2020-16 Rev.04, to reflect these changes.

Key updates include:

• SARS-CoV-2 is no longer listed under Rule 1 for life-threatening agents.
• Self-testing devices for SARS-CoV-2 detection are now classified as Class C under Rule 4a.
• A general statement under Rule 6 allows for reclassification if the epidemiological context changes.
• COVID-19 tests are now classified as Class B or C, depending on their intended use, eliminating the need for specific Class D requirements such as batch verification, EU Reference Laboratory testing, and PSUR or SSP submission.

Manufacturers are advised to consult with their Notified Bodies to understand the implications of these changes and ensure compliance. Notified Bodies will work closely with manufacturers to support a smooth transition to the new classification standards.

Additional information can be found in the press release issued by Team NB, The European Association of Medical Devices Notified Bodies, and in the updated guidance document MDCG 2020-16 Rev.04.

For further information, contact us.

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