Local view for "http://purl.org/linkedpolitics/eu/plenary/2012-06-14-Speech-4-332-500"
| Predicate | Value (sorted: default) |
|---|---|
| rdf:type | |
| dcterms:Date | |
| dcterms:Is Part Of | |
| dcterms:Language | |
| lpv:document identification number |
"en.20120614.22.4-332-500"2
|
| lpv:hasSubsequent | |
| lpv:speaker | |
| lpv:spokenAs | |
| lpv:translated text |
"Following the scandal that has taken place in France involving silicone gel breast implants produced by the company Poly Implant Prothèse, this resolution states the need to strengthen cooperation between the Member States, as well as improving ‘market surveillance, vigilance and inspection’, in order to ‘provide a better guarantee of safety of patients’ in terms of medium- and high-risk medical devices. It suggests that unannounced inspections of the whole supply chain and certain suppliers be carried out annually, as well as making the shift ‘to a system of pre-market authorisation’, in particular for the aforementioned categories of medical devices. The exchange of information between national authorities on the adverse effects of medical devices and their withdrawal from the market may improve the current framework through rapid response at national level and mitigating the impact on patients. The motion for a resolution also proposes ‘a single European database that brings together information about the medical devices available on the market, registration of economic operations and vigilance and market surveillance initiatives’. This should not be used to favour economic interests instead of ensuring the safety of patients, and neither should it jeopardise data protection, which is essential. We voted for this resolution."@en1
|
Named graphs describing this resource:
The resource appears as object in 2 triples