Regulation on medical devices: - extracts from the report - statement by Dagmar ROTH-BEHRENDT (S&D, DE), rapporteur EP Committee on the Environment, Public Health and Food Safety EPRef92849 // European Parliament , Brussels, room JAN 4Q2 - 9.00-10.30 //

Type: News   Reference: 92849   Duration: 00:02:41  Lieu: European Parliament, Brussels
End production: 20/03/2013   First transmission: 20/03/2013
- extracts from the report - statement by Dagmar ROTH-BEHRENDT (S&D, DE), rapporteur Dagmar ROTH-BEHRENDT (S&D) on the Regulation on medical devices proposal aims to achieve a suitable, robust, transparent and sustainable regulatory framework of safe, effective and innovative medical devices for the benefit of European patients, consumers and healthcare professionals. It includes certain requirements: economic operators must be able to identify who supplied them and to whom they supply or that manufacturers must fit their devices with a Unique Device Identification as well as the issue of medical devices single use.

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00:00:00 title 00:00:05
00:00:05 Exterior view of the European Parliament, Brussels 00:00:05
00:00:10 ENVI Committee meeting document 00:00:03
00:00:13 cutaways (2 shots) 00:00:07
00:00:20 Soundbite (English) by Dagmar ROTH-BEHRENDT (S&D, DE), rapporteur, one of the most important peace of legislation coming forward in the next month for European citizens and patients and their families will be the legislation on medical devices. It means everything from an injection needle up to the hip implant or abreast implant or a stent for heart diseases so we have to get it right , we have to make sure that patient safety is the first point of our agenda, means that we have to have to have the best medical expertise before a product comes onto the market, that we have enough data, enough clinical trials that the notification or authorization process is in a way guarantying the best expertise which is not in place at the moment. At the moment patients are often used as guinea pigs because the medical devices on the market sometimes are good sometimes are not. And then we have to look as well on the whole question of the use of medical devices because we have for example digital cameras used for just a look into the heart or the stomach which are supposed to be used only at one patient with one treatment but are reused because they are so expensive . So I do not want to bankrupt the hospitals but at the same time we have to look how is the reprocess guaranteed that the next patient is not getting an infection because the product is not cleaned p)properly so all those items will be mainly to be discussed in the next month in the EP. They are controversial, I would want to go for a prior authorisation of certain products; everything which will stay in my body or which delivers a pharmaceutical while it is in my body I want it to be centrally authorized before it comes to the market, the industry does not want that so we will have to find a compromise there" 00:01:57
00:02:17 Cutaways of ENVI committee meeting (4 shots) 00:00:24
00:02:41 END 00:00:00
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