Team-NB publishes position paper on conformity assessment following down-classification of SARS-CoV-2 IVDs

The European Association of Medical Devices Notified Bodies (Team-NB) has published a Position Paper titled “Considerations for conformity assessments done by (IVD) Notified Bodies in the case of down classification of SARS-CoV-2 tests”, adopted on 12 December 2025.

The document describes how IVD Notified Bodies intend to manage conformity assessments following the update of MDCG 2020-16 (Revision 4), which reflects the scientific advice issued by the IVD Expert Panel on 29 January 2025 regarding SARS-CoV-2.

Regulatory background

SARS-CoV-2 was previously considered an infectious agent causing a life-threatening disease with a high risk of propagation. As a result, IVDs intended to detect SARS-CoV-2 were generally classified as Class D under Rule 1 of Annex VIII of Regulation (EU) 2017/746 (IVDR), as reflected in MDCG 2020-16.

Following the publication of the IVD Expert Panel scientific advice in January 2025, the European Commission updated MDCG 2020-16 to Revision 4. This update modified the classification rationale applicable to SARS-CoV-2 tests.

The Commission subsequently requested IVD Notified Bodies to establish a common approach for handling potential down-classification of these devices. The Team-NB Position Paper responds to this request.

Changes reflected in MDCG 2020-16 Revision 4

According to the Position Paper, MDCG 2020-16 Rev. 4 introduced the following changes:

• SARS-CoV-2 is no longer mentioned as an example under the rationale for Rule 1, second indent

• The rationale under Rule 4a (self-testing devices) was updated to reflect that self-testing devices for detection of SARS-CoV-2 or antibodies against SARS-CoV-2 are Class C

• The rationale under Rule 6 was updated to include a general statement that classification may change following changes in the epidemiological context

• Devices intended for detection of SARS-CoV-2 and antibodies against SARS-CoV-2 were added as examples under Rule 6

Resulting classification of SARS-CoV-2 IVDs

Based on the updated guidance, the Position Paper summarises the following classification outcomes:

1. SARS-CoV-2 tests intended for professional use are classified as Class B under Rule 6

2. SARS-CoV-2 self-testing devices are classified as Class C under Rule 4a

3. Near-patient testing devices are classified independently, in line with other professional-use devices

4. Devices intended for both professional and self-testing use are classified according to the highest applicable class (Class C)

5. Multiplex devices including SARS-CoV-2 require classification to be determined on a case-by-case basis

The Position Paper notes that donor screening devices may still fall under Class D in accordance with Rule 1.

Certification scenarios addressed by Team-NB

The document describes four certification scenarios that may apply following the publication of MDCG 2020-16 Rev. 4:

• Devices with an existing Class D EU Technical Documentation Assessment Certificate

• Devices with a Class D application under review, where conformity assessment activities have started

• Devices with an accepted Class D application, where technical documentation review or audits have not yet started

• Devices with a submitted Class D application that has not yet been reviewed or accepted

For each scenario, the Position Paper outlines how Notified Bodies may revise certificates, applications, or conformity assessment activities following receipt of a change notification from the manufacturer.

Manufacturer obligations following down-classification

The Position Paper states that manufacturers are expected to submit a change notification to their Notified Body. The change notification is identified as the leading document and should include, as applicable:

• Reference to MDCG 2020-16 Rev. 4 and the IVD Expert Panel scientific advice

• Identification of the affected devices

• An impact analysis related to previously reviewed or ongoing technical documentation

• An updated Declaration of Conformity (draft)

• An updated classification justification

• Updated parts of the technical documentation (Annex II and Annex III), as applicable

• An updated risk management file, where required

The Position Paper specifies that:

• For Class B devices, a Summary of Safety and Performance (SSP) is no longer required

• For Class B devices, a PMS Report is required instead of a PSUR

Impact on certificates, surveillance and QMS

According to Team-NB:

• Existing Class D certificates remain valid until they are cancelled following completion of the change notification review

• Manufacturers remain subject to their contractual obligations as Class D until certificate changes are implemented

• Updated documentation may, in some cases, be reviewed as part of the surveillance cycle, depending on the scenario and the Notified Body’s assessment

The Position Paper notes that the manufacturer’s quality management system is not expected to be significantly affected, although specific processes may require review, including:

• Batch verification processes specific to Class D

• Stock reconciliation of previously placed Class D devices

• Updates to affected technical documentation

• Potential impact on the scope of QMS certification

Read the full document below.