Is selling Covid-19 Antigen tests to the public allowed in country ‘X’? COVID-19 self tests may become one of the solutions into regaining our full freedom in the EU. It may allow lockdowns to be lifted. Earlier we published a clear and understandable guide on Covid-19 self testers. Download the guide via this link.
However, countries are still allowed to regulate these self tests with national technical rules (or prior authorisation procedures). On March 4th, 2021, we have asked all product contact points on this subject whether or not selling Covid-19 Antigen tests to the public is allowed and whether or not national technical rules apply.
You will find the answers from the product contact points per EU Member State. This blog post will be regularly updated when we receive a response from the product contact points.
Should you need more information, or if you would like to contact a product contact point yourselves, please let us know. #productIP Stress-free product compliance
Changelog:
Info received from Product Contact Points:
No official response received from PCP
According to public information, provided by the government, the sale Covid-19 Antigen tests to the public is allowed. More information can be found here: https://www.basg.gv.at/fuer-unternehmen/medizinprodukte/covid-19
No official response received from PCP
According to public information, provided by the government, the sale Covid-19 Antigen tests to the public is allowed. More information can be found here: https://www.apb.be/nl/corp/volksgezondheid/Info-Corona/Veilig-blijven-werken-in-de-apotheek/Pages/testing-tracing.aspx
Please be aware that all self-tests need a CE-certificate from a notified body for the manufacturer to lawfully CE-mark and market self-test in EU.
Regarding labelling, according to Annex I, 8.4: “(k) if the device is intended for self-testing, that fact must be clearly stated.”
In addition, labelling and instructions for use for medical devices must be in Danish: https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/language-requirement/
Distribution of appropriately CE-marked COVID19 tests for professional use, no additional registration is required. However, in the case of self-tests, a notification to the competent authority, Fimea, is required for import into Finland. Please note that tests intended for professional use cannot be marketed to consumers for home use. Devices for self-testing require the assessment of a notified body and a certificate issued by the notified body. Actions for the importer and distributor of Sars-CoV2/Covid-19 tests We urge distributors to ensure the conformity and appropriate marketing of products in line with what is described above.
To provide Fimea with a comprehensive picture of all SARS-CoV2/COVID-19 tests available on the market in Finland, we kindly ask you to send the following documents to Fimea (laiteinfo@fimea.fi or medicaldevice@fimea.fi), unless you have already done so:
(https://www.fimea.fi/web/en/medical-devices/registration)
Hello,
Thank you for your email and I invite you to take a look at the the legal context as well as the procedure for placing this type of product on the the market of this type of product: https://covid-19.sante.gouv.fr/tests
Finally, I would like to inform you that the instruction leaflet, the labels and more generally, all information provided to the end user must be the end user must be written in French.
No official response received from PCP
According to public information, provided by the government, the sale Covid-19 Antigen tests to the public is allowed. More information can be found here: https://www.bfarm.de/DE/Medizinprodukte/Antigentests/_node.html
The HPRA is the competent authority in Ireland for the purposes of In Vitro Diagnostic Medical Devices Directive 98/79/EC as amended (IVDD) which has been transposed into Irish law by the European Communities (In vitro Diagnostic Medical Devices) Regulations 2001 SI 304/2001 as amended (IVD Regulations).
In order to CE-mark a device for self-testing, a review by a notified body is required as part of the conformity assessment procedure. Once a device is legitimately CE-marked and has undergone the appropriate conformity assessment, it may be freely placed on the Irish (European) market without any further national authorisation. To obtain the performances claimed by the manufacturer for the device, the test should be used according to the instructions for use (IFU) provided by the manufacturer.
Article 9(12) IVDD provides for the possibility of a derogation on a duly justified request from conformity assessment in the interest of protection of health. This derogation is set out in regulation 8(11) of the IVD Regulations
The HPRA’s current process for the urgent assessment of applications to use non-CE-marked medical devices (including devices which have not undergone appropriate conformity assessment) in Ireland, in the context of the COVID-19 emergency is set out on the HPRA website (“24 March 2020 – Derogation based market access for non-CE marked medical devices and IVDs for COVID-19”). The HPRA assesses these devices to determine whether the provision of non-CE marked devices is in the interest of the protection of health as specified by the regulatory framework.
Currently, applications for this derogation in the context of COVID-19, are required to include completed forms from (i) a manufacturer and (ii) a consultant. We acknowledge as currently designed that these forms are intended for devices used in a health care setting and under the direction of either a specific consultant or under the direction of the health services.
The current approach outlined by National Public Health Emergency Team (NPHET) on the use of COVID-19 testing in Ireland does not currently provide for self-testing using rapid antigen tests. However, we are aware that this matter is currently being reviewed and we acknowledge that it is an evolving situation.
We understand that the approach to the use of rapid antigen tests to supplement existing national testing programmes is under consideration within the Department of Health. Given the role of NPHET in determining the health response to the pandemic, HPRA is mindful of their advice in determining whether such tests would be required in the interest of protection of health as required in the regulatory framework.
These discussions are very relevant in determining whether there is a public health interest for the use of such tests.
As the current position is that these self-tests are not part of the national testing approach, there is no public health requirement to provide a derogation. However, in recognition of the evolving situation, HPRA will review the derogation process so as to ensure that appropriate declarations and information, can be made in the event that the public health authorities indicate that there is a public need requirement for these tests.
At the national level, the marketing, importation, advertising and use of in vitro diagnostic medical devices are governed by the amended law of January 16, 1990 relating to medical devices and by the amended Grand-Ducal regulation of July 24, 2001 relating to in vitro diagnostic medical devices.
Devices already registered by the national competent authority and bearing the CE mark, can be marketed in the countries of the EEA (European Economic Area).
Devices that are not intended for self-diagnosis/self-tests (no certificate from a notified body), they are intended for professional use only.
At national level, medical devices can be placed on the market and put into service bearing the CE marking and provided with the appropriate information written in one of the French, German or Luxembourgish languages. When the device is intended exclusively for professional use, these indications may also be drawn up in English (Art. 4 of the RGD mentioned above).
Please find the following recommendation:
Tests de la COVID-19 disponibles au Luxembourg (situation fin mars 2021) :
as well as the current ministerial derogation for some antigen tests:
Arrêté ministériel du 6 avril 2021 énumérant la liste des tests rapides d’auto-diagnostic pouvant être utilisés pour la détection du coronavirus SARS-CoV-2
http://legilux.public.lu/eli/etat/leg/amin/2021/04/06/a270/jo
If a medical device has been notified with the EU Competent Authority it may be put on the European market. It is the sole responsibility of the manufacturer to comply with the requirements of the act and the rules and regulations.
Unfortunately we cannot provide further advice on this. You can engage a consultancy.
any wholesaler of medical devices that operates within the Portuguese territory will have to notify the activity at Portal Licenciamento+. The notification form is available here, under the title “Dispositivos médicos – Notificação” (these forms are only available in PT).
Being able to choose the type of notification:
You must also notify INFARMED, I.P. of all the medical devices you distribute at national level. The online registration and fill-in guidelines are available here. According to the article 41.o of Decree-Law No. 145/2009 of 17 June, it is required that distributors notify all medical devices that are distributed in Portugal; the on-line registration for the notification of those devices is available at Sistema de Informação para Dispositivos Médicos (SIDM). All manufacturers of the medical devices must also notify the devices through the same platform (only entities excluded are non-national manufacturers of class I medical devices). There’re no fees related to this notification. At the bottom of this page, you can also watch some tutorial videos about the portal. Unfortunately, they are only in Portuguese. The access credentials to the platform will be sent by email after the registry. The spam folder should also be checked. After the access, on the frontpage of the portal, the user’s manual is available (in Portuguese)
The distribution of the medical device(s) can be started after its notification, if the wholesaler is already registered or 60 days after the notification of the activity.
Please be informed that the commercialization of medical devices is subjected to a commercialization fee of 0.4% over the volume of monthly sales, in accordance to 1st and 2nd articles of the national Decreto-Lei nº 312/2002, of December 20th, for the entity that first places the medical devices in national territory.
Further details on the fees payment are available in Taxes’ section.
For the rapid antigen tests (TRAg), suggest that you consult Estratégia Nacional de Testes para SARS-CoV-2 estabelecida pela Norma nº 019/2020, da DGS (National Test Strategy for SARS-CoV-2) and Circular Informativa Conjunta nº 004/CD/100.20.200, de 14/10/2020 (Diagnosis of COVID-19 – Antigen research tests).
Additionally, the rapid antigen tests (TRAg) of SARS-Cov-2 for professional use only, are exceptionally being accepted for self-diagnosis, under some specific criteria. You can consult the Portaria n.º 56/2021 de 12 de março (exceptional and temporary regimen for performing self-tests of rapid antigen tests, intended, by their manufacturers, to be performed on samples of the internal anterior nasal area) and Circular Informativa Conjunta N.º 005/CD/100.20.200 Data:19/03/2021 (Criteria for inclusion, operationalization of use and reporting of self-test results). These tests need the approval of INFARMED, I.P., because their use is exceptional, considering that self-tests need the intervention of a notified body, and the TRAg placed in the market don’t require the intervention of a third party (the notified body that usually is required in the conformity assessment). For more information, please consult INFARMED, I.P.’s website here.
Covid-19 self-test can be put on the Slovenian market if they have gone through the appropriate conformity assessment procedure – for self-tests that is certification by the notified body. Since such tests are meant to be used by lay people instructions for use (also if they are any on the packaging) have to be in Slovene (pursuant to Article 33 of the Slovenian Medical Device Act) and be legible, clear and have to have a date of issuing or last version/change. The contents of the translated IFU has to be the same as the original IFU. Additionally, currently such self-test can only be made available in pharmacies.
There is no prior authorisation for compliant products. Please note that in those answers we are not referring to national derogations, which can be authorised by JAZMP (NCA) if duly substantiated with a public health rationale.
In order to introduce a “Covid-19 self-tests (Antigen)” in our country it has to be:
You can find national legislation, RD 1662/2000, for In vitro medical devices, in the link bellow BOE.es - BOE-A-2000-17597 Real Decreto 1662/2000, de 29 de septiembre, sobre productos sanitarios para diagnóstico "in vitro"..
Currently, there is no special procedure established/opened for test Covid-19 intended for “professional use” to be marketed as “self test”.
For in vitro diagnostic medical devices under the IVDD that are intended to be used by lay persons (self-tests to be used at home), a third-party assessment body (a notified body) needs to be involved. The notified body will ensure that the device design and the information provided for its use are suitable for non-professional users, and will issue the corresponding certificate before the CE-mark is affixed by the manufacturer of the device.
Additionally, medical devices that are to be distributed on the Swedish market need to be labelled and have instructions for use (including user manual, operator displays etc.) regardless of the end user profession. If you are an economic operator established outside of Sweden, you generally do not need to register with the Medical Products Agency. If you are registered with the competent authority in another member state in the EU/EEA the requirements on registration is fulfilled also when placing devices, or making devices available, on the Swedish market.
Please be informed that the Swedish Public Health Agency has published a guidance document (in Swedish language only) to provide support to the Swedish healthcare, laboratories and other actors in the use of antigen test to detect covid-19. The document also provides guidance on which performance requirements are recommended for antigen tests. The guidance document does not cover antigen-tests for the purpose to be used by lay persons.
Vägledning för användning av antigentester vid covid-19 (folkhalsomyndigheten.se)
According to Icelandic law selling self-test for Covid-19 and other transmissible diseases is prohibited. The Ministry of Health provides special permits for laboratories to do tests for transmissible diseases. The Ministry is responsible for this law on transmissible diseases in Iceland and please contact them for further information hrn@hrn.is
Being a signatory to the EEA agreement, Norway has the same rights and obligations concerning medical devices as member states of the European Union. The Act of 12 January 1995 No. 6 and the Regulation of 15 December 2005 No. 1690 relating to medical devices, implement the provisions of the Active Implantable Medical Devices Directive 90/385/EEC, the Medical Devices Directive 93/42 EEC, and Directive 98/79/EC on in vitro diagnostic medical devices.
Only medical devices that are CE-marked, fulfilling the requirements in the applicable directive, can be marketed and sold in Norway. Please note the following:
New Regulations on medical devices
Regulation (EU) 2017/745 on medical devices (MDR) and (Regulation (EU) 2017/746 on in vitro diagnostic medical devices) (IVDR ) have been incorporated into the EEA Agreement by decision of the EEA Joint Committee. MDR and IVDR will be implemented into relevant Norwegian Law and Regulations.
Covid-19 tests
See information in our website regarding rapid tests and self-tests (in Norwegian). Please note that rapid tests intended for professional use cannot be sold to lay people.
More information can be found in our website (English / Norwegian).
Kindly note that in Malta Covid-19 self-test kits are illegal.
Legal Notice 49 of 2021 has further information that you may wish to look into.