In September 2012, the European Commission launched a renewed legislative package for medical devices and In Vitro diagnostic medical devices. The procedure is now approaching its end, however a number of important discussions are still taking place.

Amendment 40

Until now, HIV testing has only been possible by way of a doctor’s prescription; however with the draft proposal on IVD Medical Devices, HIV testing would become possible at home.

A number of concerned MEPs called for a modification that would ban self-testing-kits of certain devices, thereby making it only available upon medical prescription.

Hence a number of organisations from the public health community, including European AIDS Treatment Group (EATG), are advocating for not banning these types of tests since they can play an important role in early diagnosis and help patients obtain the full benefit of treatment and care.

UPDDATE: 22 October Plenary vote

The plenary vote took place last Tuesday 22 October in Strasbourg. Amendment 40 fells since AM 268 was approved. This amendment foresees that Member States may provide these kind of tests without medical prescription. Thus it is up to the Member States to decide whether or not they wish to restrict HIV self-testing.

What is a self-testing device?

According to the proposal for a Regulation on In Vitro diagnostic medical devices, a device for self-testing means any device intended by the manufacturer to be used by lay persons. Several types of tests can be conducted with these devices, e.g. in non-clinical settings and at home, ranging from pregnancy tests to tests such as HIV tests, which th results can have a serious impact on public health.

Pros and cons of HIV self-testing

Conducting HIV tests in a medical centre can be a barrier for the patient, since the stigma around HIV is still a reality. Hence home testing can be a way to motivate people to perform this kind of test. According to HIV Testing Week, today at least one in three of the 2.3 million people living with HIV in Europe are unaware that they are HIV positive. Moreover, 50% of those who are HIV positive are diagnosed late, which delays their access to treatment. [1].

Rapid self-tests can be used by individuals when and where it is convenient. They do not require specialised equipment and can be carried out both in clinical and non-clinical facilities, e.g. by appropriately trained personnel including counsellors. Despite the fact that those tests are prepared to be performed at home, does not mean that they are less safety for users. Trained laboratory supervises are required for supervision and quality assurance in order to ensure an additional layer of safety for patient. [2]. Furthermore, if national legislation allows non-prescription tests, it will prevent people, from buying poor quality kits online, since they do not need to buy them "in black market"/illegally.

While self-testing thus opens up pathways for ’discreet’ testing, it should be noted that, even if the instructions are provided jointly with the device, patients run the risk of using tests erroneously or of misunderstanding the results, which can have a potentially serious impact on individuals. As stated by the Rapporteur of the IVD Medical Devices proposal Peter Liese (S&D, Germany), a false negative test can also cause serious problems for, for example, blood donation. Hence self-tests must be used in a responsible way and EPHA supports the provision related to self-testing which should direct users to obtain correct advice from a health professional.

Text proposed by the Commission

This Regulation shall not affect national laws which require that certain devices may only be supplied on a medical prescription.

Amendment 268 (Adopted on 22 October, 2013 Vote

This Regulation provides that certain devices may only be supplied on a medical prescription but it shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this Regulation shall be illegal. The following devices may only be supplied on a medical prescription: 1) Class D devices; 2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. By derogation, justified by the attainment of a high level of public health protection, Members States may maintain or introduce national provisions allowing special class D tests to also be available without a medical prescription. In that case, they shall duly inform the Commission. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide that other class C tests may only be supplied on a medical prescription after consultation with stakeholders.

Amendment 40 (Not Adopted on 22 October, 2013 Vote)

This Regulation provides that certain devices may only be supplied on a medical prescription but it shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this Regulation shall be illegal. The following devices may only be supplied on a medical prescription: 1) Class D devices; high risk device 2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide that other class C tests may only be supplied on a medical prescription after consultation with stakeholders.


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Last modified on October 25 2013.