Since early this year, the COVID-19 virus substantially affects our daily life. Testing for the presence of or past exposure to the virus is an essential aspect of combatting the COVID-19 outbreak and a number of companies are developing testing solutions for healthcare professionals and patients. These testing solutions are regulated as in vitro diagnostic medical devices (IVDs) in the European Union (EU) and fall within the scope of the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVD Directive).
Before being marketed in the EU, IVDs must be CE marked following a conformity assessment during which compliance with the Essential Requirements of the IVD Directive must be demonstrated. Although testing solutions intended for use by healthcare professionals with their patients do not require the involvement of a notified body, the rules are however different for self-testing kits.
For self-testing kits, the IVD Directive provides that manufacturers must lodge an application for examination of the device design with a notified body. Annex III, Section 6 of the IVD Directive provides that the application shall enable the design of the device to be understood and include:
- test reports including, where appropriate, results of studies carried out with lay persons,
- data showing the handling suitability of the device in view of its intended purpose for self-testing,
- the information to be provided with the device on its label and its instructions for use.
If the review by the notified body is successful, the manufacturer will receive a CE Certificate of Conformity from its notified body and will be able to prepare a Declaration of Conformity and affix the CE mark to the self-testing kit. This CE mark should be accompanied by the four digit number of the notified body involved in the conformity assessment procedure.
Testing solutions which are intended to be used by healthcare professionals should bear the same CE mark to evidence their conformity with the IVD Directive but without any digit numbers.
In the European Commission’s Communications, Guidelines on COVID-19 in vitro diagnostic tests and their performance, the European Commission provided that good performance of self-testing kits is key as those tests are intended to lay user. EU Member State competent authorities are generally not in favour of the use of COVID-19 self-testing kits in the current context of the pandemic. A reason for this is the possible difficulty for the untrained lay user to make the correct interpretation of the result and its implications (e.g. that the result could be a false positive or false negative which a health professional could identify by taking into account the clinical context of the patient).
As an example, the Belgian Federal Agency for medicines and health products (AFMPS/FAGG) banned in March 2020 the sale, distribution and use of rapid self-testing kits for the detection of antibodies against COVID-19 for a period of six months. The ban was lifted on 19 September 2020. However, the AFMPS/FAGG warns users that there are significant reservations about both negative and positive results of these tests and that these self-tests can give users a false sense of security or cause them unnecessary anxiety. Similar measures were adopted in other EU Member States. In its guidelines, the European Commission also pointed out that making devices destined for professional use available to lay users, e.g. via pharmacies or on the web, is not legally permitted.