Rapid tests and self‍-‍tests for COVID‍‍‍-‍19

Difference between rapid tests and self‍-‍tests

What determines whether a product is to be considered a rapid test or a self‍-‍test is the intended purpose and the intended user of the product. Only the manufacturer can decide the intended use. The intended purpose must be apparent from the product’s labelling and instructions for use.

Rapid tests, or diagnostic devices intended for near patient use (also referred to as point of care testing), are tests which are performed and read by healthcare professionals near the patient. For example by the patient’s side. This in contrast to tests used within healthcare that are analysed in a laboratory. Devices intended for near patient testing are not intended for consumers.

Self-tests are intended to be used by consumers in the home environment as opposed to tests which are used in healthcare institutions. A self‍-‍test is a kit where a consumer (lay person) takes a sample in the home environment and interprets the test result on their own. Lay persons are persons without formal education in a relevant field of healthcare or medical discipline.

There are also devices (e.g. swabs or test tubes) that are used to take samples at home that are then sent to a healthcare institution or laboratory for analysis. Such devices are not self‍-‍tests but kits for self-sampling.

Tests must be CE marked by the manufacturer and may be checked by the authority

Tests that are intended for detecting disease by analysing a sample taken from the body are considered IVD devices*. They must be CE marked by their manufacturer.

CE marking does not mean that an authority has authorised the device. The authorities’ role is to supervise the devices that are sold on the market. CE marked devices must also be subject to supervision to ensure that they meet the requirements for CE marking. If the requirements are not met, measures must be taken.

*in vitro diagnostic medical devices.

Different conditions apply for CE marking rapid tests and self‍-‍tests

Rapid tests are generally considered IVD devices. This type of device is CE marked by the manufacturer under their own responsibility when there is sufficient basis for preparing the documentation that is needed. The documentation must, inter alia, show that the device has a sufficient level of certainty for the results, is safe to use and that the intended user can use the product correctly and read and interpret the results accurately.

The manufacturer signs a document entitled declaration of conformity as proof that the manufacturer has assumed the responsibility for ensuring that the device meets the requirements of the regulatory frameworks. As this type of device is not intended for self‍-‍testing but only for use by trained staff in healthcare institutions, the manufacturer may presume that the user can handle devices and interpret results that are more complex.

Self-tests, as opposed to rapid tests, must be reviewed by an independent verification body, known as a notified body, before the devices can be CE marked by their manufacturer. The manufacturer must also have sufficient basis for preparing documentation that shows, inter alia, that the device has a sufficient level of certainty for the results, is safe to use and that the intended user can use the device correctly and read and interpret the results accurately.

As this type of device is intended for users that do not have training in the field, the method of use and reading of the results must be simple and unambiguous. The notified body reviews the manufacturer’s documentation. It must specifically investigate that the device is suitable to be a self‍-‍test. When the notified body deems the device to meet the requirements, it issues a certificate, the EC certificate. Only then may the manufacturer CE mark the self-test. The device is marked with a four-digit code next to the CE mark to show that is has a certificate.

Tests may only be imported and sold if they are correctly CE marked

An IVD device that is correctly CE marked for its intended purpose may be sold on the Swedish market if it also meets language requirements. Self‍-‍tests, and certain other devices specifically listed in the regulatory framework, requires prior assessment by a notified body in order to be correctly CE marking .

A device that is to be sold on the Swedish market must have labelling and instructions for use in Swedish when the product reaches the end user. Translation into Swedish must be done by, or in close collaboration with, the manufacturer. Only the manufacturer may make changes to the devices.

Devices from the EU/EEA

IVD devices that are correctly CE marked and have their manufacturers within the EU/EEA have free movement within the Union and the countries belonging to the EEA. However, all Member States have national regulations for the language(s) that must be used in labelling and instructions for use.

Devices from third countries

For IVD devices that are imported from third countries (countries outside the EU/EEA), the manufacturer must then have an authorised representative (AR, EC REP) within the EU/EEA. It should be noted that the AR is a specific role in the regulatory framework and the requirement for AR is not necessarily met just because there is an agent/wholesaler within the EU/EEA. In the same way as above, the devices must be correctly CE marked in accordance with the regulatory frameworks in the EU/EEA and the devices’ labelling and instructions must be in Swedish.

If the devices are correctly CE marked and there is an AR, then free movement prevails.

Devices may not be sold for anything other than their intended purpose

Devices may not be sold or marketed in such a way that it may be interpreted that they are suitable for anything other than their intended purpose. As regards tests, this means that rapid tests intended for professional use in healthcare may not be sold to private persons for self-testing at home. This is because home use is not included in the manufacturer’s intended purpose and they therefore have not produced evidence that the device has the correct performance, safety and suitability for self‍-‍testing by lay persons.

In accordance with the Swedish implementation of the General Product Safety Directive, Produktsäkerhetslagen, devices that are aimed at consumers for self‍-‍testing must be safe for that purpose. You may also not market tests in such a way that they appear more reliable than what the documentation supports.

The Medical Products Agency’s responsibility applies to the supervision of IVD devices

The Medical Products Agency is responsible for supervising that the devices meet the conditions named above for their CE marking and that the devices are not sold or marketed in violation of regulatory frameworks.

However, the Medical Products Agency is not responsible for regulating and controlling how the tests are used by healthcare institutions. The National Board of Health and Welfare is responsible for regulating and the Health and Social Care Inspectorate (IVO) is responsible for supervision. The Medical Products Agency does not govern or issue recommendations regarding which tests, for example for COVID‍-‍19, must be used by healthcare institutions. The Public Health Agency of Sweden works as a methodological and quality support to healthcare institutions on this matter.

The Medical Products Agency is also not responsible for the supply of goods; this is the responsibility of the National Board of Health and Welfare. The Medical Products Agency collaborates with other authorities to assist in protecting public health.

The Medical Products Agency may also, in certain cases where it may be considered justified in order to protect public health, grant exemptions from certain requirements in the regulatory frameworks. In these cases, however, the devices must meet equivalent requirements for performance and safety as prescribed by the regulatory frameworks. Generally, exemptions are not granted if there are equivalent CE marked products available.