In Vitro Diagnostic medical devices: -Extracts from the exchange of views -Statement by Peter LIESE, rapporteur (EPP, DE) European Parliament, Brussels

Type: News   Reference: 92850   Duration: 00:04:54  Lieu: European Parliament, Brussels
End production: 20/03/2013   First transmission: 20/03/2013
ENVI MEPs discussed today a report by Peter LIESE (EPP) on the In Vitro Diagnostic Medical Devices (IVDs). The current EU regulatory framework for IVDs consists of Directive 98/79/EC and, after the PIP breast implants scandal, the EP adopted on June 2012 a Resolution on defective silicone gel breast implants and called for an adequate legal framework to guarantee the safety of medical technology, which should be applied with this revision of the regulation. In an internal market with 32 participating countries and subject to constant scientific and technological progress, substantial divergences in the interpretation and application of the rules have emerge in, for example, undermining the safety and performance of the IVDs and their free movement. This revision of the current regulatory framework aims to overcome its flaws and gaps and to strengthen patient safety. It should be noted that this proposal is adopted alongside a proposal for a Regulation on medical devices. While the specific features of IVDs and of the IVD sector require the adoption of a specific legislation distinct from the legislation on other medical devices, the horizontal aspects common to both sectors have been aligned.

Only the original language version is authentic and it prevails in the event of its differing from the translated versions.
PDF version

00:00:00 Title 00:00:05
00:00:05 Exterior of the European Parliament in Brussels 00:00:05
00:00:10 Peter LIESE sitting down 00:00:08
00:00:18 SOUNDBITE (German) Peter LIESE, rapporteur (EPP, DE): "In Vitro Medical Diagnostic Devices concern all tests carried out outside the patient's body such as blood-sugar testing and HIV or other highly sensitive tests, and DNA testing" 00:00:16
00:00:34 SOUNDBITE (German) Peter LIESE, rapporteur (EPP, DE): "The Commission is initially regulating product quality and is taking a big step forward which I support but I talked to experts in the Council of Europe, the OECD, the scientists who are dealing with this, the Society for Human Genetics and they say often is more decisive to look at the context in which the product is used and how the results are interpreted, that's sometimes more important than whether the product itself is OK" 00:00:30
00:01:04 SOUNDBITE (German) Peter LIESE, rapporteur (EPP, DE): "If a test which could have very serious consequences that could turn someone's life upside down it should not be performed on a street corner but only after careful medical advice setting out all the possible consequences flowing from that test, I think that should be basic across Europe. Thank you". 00:00:20
00:01:24 SOUNDBITE (German) Dagmar ROTH-BEHRENDT (S&D, DE): "I am a bit unsettled that genetic tests may get a bad reputation, we need to ensure that in families where there's a genetic disorder it is possible for children or family members or people who want to reach a decision on whether to have children or not are enabled to be tested genetically as it is available". 00:00:32
00:01:56 SOUNDBITE (English) Rebecca TAYLOR (ALDE, UK): "We need to work towards greater effectiveness of diagnosis with all classes of IVD and hopefully in the future if clinicians are able to have more information including clinical evidence then that can guide them as to which devices they would use". 00:00:18
00:02:14 SOUNDBITE (Danish) Margrete AUKEN (Greens/EFA, DK): "The aim is that the rules should be common and viable and that the diagnostic devices should be similar across Europe" 00:00:10
00:02:24 SOUNDBITE (Slovenian) Alojz PETERLE (EPP, Slovenia): "I think that the objective of all this is that on the producer side and amongst those bodies who are scrutinising; amongst all bodies that are involved it doesn't just come down to the quality of devices but also to the interpretation, because a false interpretation of results can lead to misjudged actions". 00:00:31
00:02:55 Cutaways (3 shots) 00:00:12
00:03:07 Statement (English) by Peter LIESE, rapporteur (EPP, DE): "We have unfortunately serious problems with diagnostic devices in Europe. For example, there was an HIV test on the market for more than 10 years when scientists already said in the beginning it was a bad test, it was showing a lot of false negative results which means that the test says you don't have HIV but in fact you have it. This is very dangerous for blood transfusion and also for the partner of the person concerned and this test should be removed from the market and the current regulation was not good enough in removing bad tests form the market, and of course you cannot do it at national level, we have a common market so when a test is approved in one Member State it crosses the border and that's why it needs to be addressed at European level" 00:00:55
00:04:02 Statement (English) by Peter LIESE, rapporteur (EPP, DE): "I think I work on the basis of the European Commission and try to improve it, it's a big step forward but we need to improve it. There's one additional point I want to make, that's the question of informed consent. Even if you have high quality tests, if it's done without informing the patient properly in the worse case, without having any information, that you can take a sample of your neighbour and try to find out if he has HIV or a genetic disease, that is unacceptable, but also people affected need to be informed before the test is done because it has a lot of consequences for example for the family, for the planning of their life, and that's why it should be done by a doctor withy proper information and not on the internet or on the street" 00:00:52
00:04:54 END 00:00:00
Audiovisual Services
European Commission
Conditions of use
© European Union, 2015