The new EU Regulation on in vitro diagnostic devices (IVDR), applicable since May 26, 2022, affected the classification and compliance process of COVID-19 tests. Manufacturers that want to sell devices for detecting SARS-CoV-2 must be aware of the new regulatory framework.
New classification and compliance process
Under IVDR, COVID-19 tests, including rapid antigen self-testing, are classified as class D (highest risk) as they detect the presence of a virus that causes a life-threatening disease with a high risk of propagation (rule 1).
Considering the new classification, COVID-19 tests require a CE Certificate by a Notified Body. Furthermore, manufacturers can choose between two different conformity assessment routes:
- Quality Management System Assurance (Annex IX) + Assessment of technical documentation by a NB (Annex IX, chapter II) + Verification by EU reference laboratories.
- Type Examination (Annex X) + Production Quality Assurance (Annex XI) + Verification by EU reference laboratories.
In short, EU reference laboratories (designated by the European Commission) verify the performance claimed by the manufacturer through laboratory testing.
Additionally, in June 2022, the European Commission published common specifications for class D IVDs that contain detailed performance characteristics. After the transitional period ends, these common specifications will become mandatory for manufacturers. Except if they adopt solutions to ensure an equivalent level of safety and performance.
Transition period
Under IVDD, COVID-19 tests did not need a certificate by a Notified Body; hence, those devices benefit from the transition period for legacy devices. Therefore, until May 26, 2026, COVID-19 tests can continue to be placed on the EU market if:
- They comply with IVDD;
- They meet some IVDR requirements — Specifically concerning post-market surveillance, vigilance, and registration of economic operators and devices;
- They do not present significant changes to their design and intended purpose. On this point, Belgian Authority confirmed that when Covid-19 tests are modified to detect a new variant of the virus, such modification is a significant change as it is an extension of the intended purpose. Click here for more information on what is a significant and a non-significant change to your device.
However, considering the lack of NB appointed under IVDR and the huge number of devices to be assessed, manufacturers shall already secure a NB to be ready by the deadline.
Common list of COVID-19 antigen tests
During the COVID-19 pandemic, EU Member States decided to set a common framework for COVID-19 tests across the EU. In light of this, the Health Security Committee (HSC) has drafted the EU common list of COVID-19 antigen tests, including IVDs that meet specific requirements and therefore are mutually recognised in the EU.
The list is updated frequently to add new tests and remove those that are considered no longer effective.
Being included in the list is a substantial commercial advantage on the EU market — Obelis can help you apply for it; check our dedicated service.
Lastly, it is worth mentioning that in the case of COVID-19 test kits that include a swab, the latter is a class I medical device that, therefore, shall comply with MDR.
Do you manufacture COVID-19 tests and want to know more about EU requirements? Contact us: we will assist you in placing your devices on the EU market!
Francesca Santacatterina
Publications department
09/02/2023
References
BSI. (2023). IVDR Conformity Assessment Routes. Retrieved on 09/02/2023
European Commission. (2023). EU Common list of COVID-19 antigen tests. Retrieved on 09/02/2023
European Commission. (2022). Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022. Retrieved on 09/02/2023
European Commission. (2017). Regulation (EU) 2017/746 on in vitro diagnostic medical devices. Retrieved on 09/02/2023
MDCG. (2022). Guidance on classification rules for in vitro diagnostic medical devices under Regulation (EU) 2017/746. Retrieved on 09/02/2023
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