In vitro diagnostic (IVD) devices are medical devices intended for diagnostic use outside the human body, which may be done in a laboratory or near the patient, for example at the bedside. It covers a huge variety of tests such as a self-test for blood sugar measuring, HIV tests and DNA tests.

The term medical device refers to any instrument, apparatus, device, software, implant, reagent, material or other object, for which the manufacturer previse that it will be used for medical purposes. Medical devices are part of the support to other methods of treatment.

Why is it important to improve the regulation of IVD medical devices?

In vitro diagnostic devices are essence and foundation of all therapies, including pharmaceutical products and surgery. Without a proper diagnostic there is no proper treatment or prevention of diseases. Unfortunately the current directive does not assure that low quality IVD medical devices are not placed on the market.

Best known examples of low quality medical devices under the current regulation:

• HIV tests
• Hepatitis C tests
• DNA tests

Due to low quality medical devices fatal mistakes occurred in the past, which should not be repeated. One example is low quality HIV test that already had certificate of suitability. Later, scientific institute determined that these tests announced much more false negative results than other HIV tests available. However, this product was available for years for patients in the EU.

We need to know that if a blood transfusion is performed on the basis of a false negative result on HIV, this is a life-threatening risk for the recipient of the blood transfusion. Such persons also endanger their loved ones. Similar cases, such as with HIV have been reported also with hepatitis C. The best known case is when an expert for DNA-tests has sent the same sample to four different laboratories and received four different results.

Genetic test refers to a test, which is performed in medical purpose and includes analysis of biological samples of human origin. It is intended solely to identify characteristic of person which are inherited.

Why the EU needs to regulate these issues?

In vitro diagnostic medical devices are products that can circulate free in the common market. There are no national borders for these products in the European market. That is why it is an obligation for the European Union to ensure the highest possible safety.

Major improvements to address the current shortcomings

Significant improvements are being introduced similar to those for other medical devices. Unannounced inspections will be mandatory. Moreover, the Commission proposes to introduce a network of European reference laboratories which have an important role in the control of high-risk medical devices.

European Commission proposes to regulate in vitro diagnostic medical devices in the same way as other medical devices.

Proposal that is acceptable for small and medium-sized enterprises (SMEs)

In the area of in vitro diagnostic medical devices many companies offering these devices are SMEs. That is why the regulation needs to take into account the capacity of SMEs to cover the burden. Of course this should not compromise health and safety. Amendments are tabled to take into account capacity and needs of SMEs. For example it should be possible to provide some requested information electronically and it needs to be specified; that the information accompanied the product shall be provided in an official union language. Both changes reduce the potential burden for SMEs.

Self-testing and near patient testing

Tests that are not performed by medical professionals but by patients need to be regulated even more carefully because medical professionals may include other elements of their diagnosis while laypersons may depend their decision only on the test. Due to lack of knowledge, this may be misleading.

Discrimination for people with a handicap

The European Union has ratified the UN Convention on non-discrimination on handicapped people. This should be reflected in the text. For example in the definition the wording “congenital abnormality” may be seen as a discrimination of handicapped people and should be changed.

Informed consent

The Commission proposal focuses very much on the quality of the product. Experts and many international organisations have repeatedly articulated their position that in many case even more important than the quality of the product is the framework in which the product is applied. Especially in DNA testing it is very important to respect the principle of informed consent. This has also been asked for by the European Parliament several times.

Long-standing policy of the European Union is that the question if to allow, prohibit or allow within limits of sensible ethical technologies, such as genetic testing is subject to the principle of subsidiarity.

Furthermore, we need to ensure consumer protection. It is therefore important that all procedures are transparent. We have to ensure the same standards across the whole European Union.