COVID-19: A short guide to CE marked IVDs
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- COVID-19: A short guide to CE marked IVDs
What is an IVD
An in vitro diagnostic medical device is a subtype of medical device intended specifically for examination of specimens that come from the human body for a medical purpose, e.g., to give a diagnosis or to monitor treatment[1].
While most of these tests are designed to be performed in a lab, like a blood test at a hospital, certain IVDs can be performed at home, such as pregnancy tests and some types of COVID-19 tests.
| IVD Examples | Types of COVID-19 Tests |
|---|---|
|
There are broadly two types of COVID-19 in vitro diagnostic tests performed on samples taken from the human body:
|
Antigen Tests
RT-PCR is still considered the gold standard and is the primary test method used to detect COVID-19. However Rapid Antigen Detection Tests (RADTs) can be used to detect the presence of a viral antigen in the patient’s specimen (e.g., nasopharyngeal/mouth sample). These tests typically require minutes to generate a result and are relatively low cost. But as they do not amplify the viral antigen, they have lower specificity compared to RT-PCR[3]. Sensitivity and specificity broadly indicate how many false negative and false positive results will be generated using these tests in a general population.
If Antigen tests are used in place of RT-PCR testing the WHO recommends antigen tests that meet the minimum performance requirements of ≥ 80 % sensitivity and ≥ 97 % specificity[4] while the ECDC suggest using tests with a performance closer to RT-PCR, i.e., ≥ 90 % sensitivity and ≥ 97 % specificity[5].
It is important to note that in terms of intended user, a RADT may be designed by the manufacturer to be used by health care professionals (General Tests) or by lay users (Self-Tests).[6]
A list of COVID-19 tests available in the EU can be found here.
What is a CE Mark?
A CE mark is a declaration that the product complies with the relevant requirements of the relevant European legislation. A large variety of products in the EU carry a CE mark, not just medical devices.
However, this means that a CE mark represents different things for different products-a lightbulb follows different regulations than a phone charger. Medical devices also follow different directives and regulations.
IVDs, including COVID-19 tests, have their own directives and regulations outlining specific CE marking requirements.
CE Marking of COVID-19 Tests
Any manufacturer can apply a CE mark if they meet the relevant requirements. However, depending on the legislation and class of the device, an external and impartial organisation may be required to independently assess if the manufacturer has met these requirements.
This is known as ‘conformity assessment’ and for Medical Devices and IVDs an organisation that performs conformity assessment in Europe is known as a Notified Body. The NSAI is a Notified Body for Medical Devices and IVDs and is identified by the Notified Body number 0050.
As COVID-19 tests are IVDs, the directive that they fall under is called The In Vitro Diagnostic Directive (IVDD) 98/79/EC.
There is an important distinction within the different classifications of IVDs under the IVDD 98/79/EC; while all manufacturers that affix a CE mark to their IVD must meet the relevant essential requirements of the IVDD 98/79/EC, not all IVDs require confirmation of this through conformity assessment via a Notified Body[7].
According to the IVDD 98/79/EC, devices are divided according to four categories: List A, List B, Self-Test, and General and have different paths to market depending on classification type[8]. COVID-19 tests can be classified under the category of General or Self-Test depending on their intended purpose.
- COVID-19 tests which are indicated for use by healthcare professionals are classified as General IVDs and are often referred to as ‘self-declare’. This means that they do not require involvement by a Notified Body regarding conformity assessment. Instead, the manufacturer ‘self-declares’ their conformity to the Essential requirements within the IVDD.
- COVID-19 tests which are indicated for use by lay persons (not medical professionals) are classified as Self-Test. This means they do require Notified Body involvement to assess conformity to the applicable regulatory requirements.
| IVDD Category | Requires a Notified Body | Example |
|---|---|---|
| List A | Yes | ABO Blood Groups |
| List B | Yes | PSA, Blood sugar measurement |
| Self-Test | Yes | RADTs (Rapid Antigen Detection Kits) for self-test. |
| General | No | RADTs (Rapid Antigen Detection Kits) for professional use only. |
The responsibility for market surveillance for all IVD products falls to the national Competent Authority. In Ireland this is the Health Products Regulatory Authority (HPRA).
It is important to note that whether an IVD requires a Notified Body or not, all IVDs must meet the relevant requirements of the IVDD as described in Annex I of 98/79/EC, as per Article 3. A Declaration of Conformity (DoC) stating as such is required for all IVDs. The ‘DoC’ is the responsibility of the Manufacturer and must be kept in the European Community and accessible for inspection by the Competent Authority.
Changes
In Vitro Diagnostics have changed significantly both in complexity and availability since the IVDD was published in 1998. Regulation (EU) 2017/746 will come into application on 26 May 2022. It will significantly change the regulatory framework for IVDs in the EU. For example, it introduces a risk-based device classification system, replacing the simple list of high-risk devices under Directive 98/79/EC. Under Regulation (EU) 2017/746, COVID-19 IVDs will generally be classified in the highest risk class, class D. The Regulation introduces assessment by third-party bodies independent from the manufacturer (Notified Bodies) for the vast majority of IVDs, including COVID-19 devices. NSAI is currently pursuing designation under the IVDR 2017/746.
More Information
CE marking of COVID-19 tests is a complicated process that involves many actors such as manufacturers, relevant Competent Authorities and Notified Bodies, if applicable[9]. For a comprehensive review visit the European Commission website and see the Q&A document ‘COVID-19 Tests: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 available here.
If you have an issue, complaint or query about a COVID-19 test that has been purchased in Ireland, please contact the manufacturer/authorised representative as specified on the label or the HPRA.
References
[1] See Article 1 (2) (b) of Directive 98/79/EC for a full definition.
[2] See Guidance by the European Commission: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19.
[3] See ECDC Options for the use of rapid antigen tests for COVID-19 in the EU/EEA and the UK.
[4] See (9) of Commission Recommendation (EU) 2020/1743.
[5] See ECDC Options for the use of rapid antigen tests for COVID-19 in the EU/EEA and the UK.
[6] See Guidelines on COVID-19 in vitro diagnostic tests and their performance.
[7] See Article 16 and Annex I of Directive 98/79/EC.
[8] See Article 9 of Directive 98/79/EC.
[9] See Guidance by the European Commission: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19.