COVID-19 antigen test for self-test

01 June 2021

Based on the current situation with regards to the re-opening of Denmark, the Danish Medicines Agency is currently experiencing an increasing number of inquiries regarding the marketing of COVID-19 tests which are CE- marked for professional use. Many inquiries concern the possible marketing of such tests as self-tests to be performed by lay persons in a domestic environment.

All tests for diagnosing of COVID-19 using samples derived from the human body, are considered to be in vitro diagnostic medical devices (IVD), which is why they must be CE marked before they enter the Danish market. The CE mark indicates that the device complies with the EU legislation and that the device has been subjected to the applicable conformity assessment procedure described in the In Vitro Diagnostic Medical Devices Directive (Directive 98/79 / EC). The Directive is implemented in the Danish Executive Order no. 1269 for in vitro diagnostic medical devices.

It is also a requirement in the Danish legislation that the labelling and instructions for use (IFU) of medical devices must be in Danish. Danish labelling and instructions for use are the manufacturer's responsibility, and must be part of the manufacturer's technical documentation if the manufacturer markets medical devices in Denmark.

Further, the IVD legislation sets special requirements for any IVD device that the manufacturer intends to market as self-test device:

  • The device must be certified by a notified body before it can be correctly CE-marked and marketed as a self-test by lay people
  • The device must be followed by an instruction for use written in an understandable language for the intended user of the device
  • Labelling and instructions for use must be in Danish
  • It must be possible for lay man to interpret the result in a way that it cannot be misinterpreted

Annex I of the IVD legislation contains a number of essential requirements which the manufacturers must be able to document before affixing the CE mark, especially with regard to documentation of safety and performance. The essential requirements contain additional requirements for devices for self-test, e.g. special labelling requirements, including that, if the device is intended for self-testing, this must be clearly stated.

Under certain circumstances, the Danish Medicines Agency may authorise the non-CE-marked device to be placed on the market in Denmark by way of derogation in accordance with the Executive Order 1269 on Medical Device for In Vitro Diagnostics, Section 6, subsection 11.

It is solely the manufacturer of the in vitro medical device, or its EU representative who can apply for a derogation. Importers and / or distributors who intend to sell medical devices on the Danish market cannot apply.

In order for an application for derogation for a specific IVD-medical device to be considered, the Danish Medicines Agency sets a number of requirements and conditions. Each application is assessed individually.

The requirements/conditions in the list below are not necessarily exhaustive.

  • Only the manufacturer can apply for a dispensation, possibly via their EU authorized representative.
  • The manufacturer must be able to document that the device is safe to use and have sufficient documentation of its performance in the relevant user group for self-test. In practice this means that the Danish Medicines Agency will only be able to grant exemption for devices that already are in the process of being certified as a self-test device by a Notified Body.
  • An application can only be considered in case specific health considerations warrant it.
  • In principle, only products that are already CE-marked for health professionals (by self-declaration) can be considered for a dispensation.
  • The product must comply with the applicable language and labelling requirements for In vitro diagnostic devices (Danish language requirements).
  • The test must be accompanied by a detailed physical instruction for use (IFU), targeted lay people and the intended user group. For example, this may include specific use-scenario where test of children must take place under the supervision of an adult.
  • Additional labelling in Danish, i.e. an instruction for use in order to fulfil of the Danish language requirement, will in principle not necessarily require repackaging of the device, but can in most cases be done by i.e. adding self-adhesive labels, and this is carried out under the manufacturer's responsibility and quality management system.
  • Manufacturers can expect a condition that the user shall be informed that the product is marketed under a dispensation for non-CE marked product, i.e. by a self-adhesive label attached to the product outer packaging
  • The manufacturer must have in place a system for vigilance and to report any incidents, as well as ensure traceability of products by i.e. batch / LOT numbers. Products marketed under dispensation will in principle be given a condition of stricter reporting obligation in relation to incidents.
  • Documentation for the product must be kept for a minimum of 5 years.

Any exemption is granted for a limited period of time, and often limited until the CE mark for self-test has been obtained or until available CE-marked alternative has been made available on the European market. Furthermore, the Danish Medicines Agency must on an ongoing basis be kept informed about progress, or lack thereof to obtain the CE mark. In the event of a change to the product occurs during the dispensation period, the Danish Medicines Agency must be informed. In relation to this, it must be examined whether the change of the device is covered by the dispensation, or whether the change requires a new application. The derogation lapses if a notified body considers that the existing technical documentation is not sufficient for the CE certification of the product.

It follows from section 4, subsection 1, of the Danish Executive Order 1269 on In Vitro Diagnostic Medical Devices that a medical device may only be placed on the market, sold, distributed or put into service, if 1) it complies with the essential requirements regarding safety, performance and labelling of section 3, 2) it has been subject to a conformity assessment according to section 6, and 3) bears a CE marking.

It is also important to be aware of the advertising rules when marketing medical devices, and which relate to both written and oral advertising materials and information.

Advertising of medical devices must be adequate and factual. The information in an advertisement for a medical device must be in accordance with the intended purpose and scope of the device, as declared by the manufacturer. The advertisement must not contain incorrect, misleading, exaggerated or incomplete information.

If a device, according to the manufacturer's intended purpose, only shall be used by health professionals, this must be part of the information from a supplier to a potential buyer in Denmark.,

Danish manufacturers, authorized representatives, distributors and importers of medical devices must register with the Danish Medicines Agency and provide information about the company's address, the device's class / type and product group.

The health authorities' current test strategy in Denmark is based on a fine-meshed network of publicly tendered PCR tests and private tendered antigen rapid tests performed under the delegation of responsibility by a health care professional. The Danish test strategy does not include self-test, with no reporting for infection surveillance purpose. At present, there is no health consideration in favour of issuing dispensation for the free marketing of non-CE-marked COVID-19 tests for self-testing.

At present, no derogation from a CE mark for self-test has been issued for COVID-19 antigen tests for free marketing in Denmark. If the Danish Medicines Agency issues a dispensation, this will appear here on the website.

Exclusively for the use within schools and educational institutions, and in connection with the reopening-strategy in Denmark, the Danish Medicines Agency has exceptionally issued a dispensation for derogation for a CE mark for self-test for these specific COVID-19 antigen test mentioned below.

The exemptions issued are issued to the manufacturer with the conditions that the test must be accompanied by the following, which has been submitted by the manufacturers to the Danish Medicines Agency as part of the application for an exemption.

- a Danish IFU targeted the intended user group

- additional labelling that the product is marketed under an authorisation for a specific use situation

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