Parliament today approved stricter rules to ensure that medical devices, such as breast or hip implants, are traceable and comply with safety requirements. The deputies But there will be even more after-sales surveillance<\/strong> and patient information. \u201cWe have also agreed to a much more effective aftermarket surveillance system so that any unexpected problems are identified and resolved as soon as possible,\u201d added Wilmott. Now comes the transitional period, of three years<\/strong> for the implementation of the regulations for ordinary devices<\/strong> and of five for those in vitro<\/strong>. If a country fails to implement the regulations thus envisaged, the infringement procedure by the European Commission for violation of European Union law will be triggered.<\/p>\n Related news:\u00a0Medical devices: more safety and traceability<\/span><\/a><\/p>\n Texts approved (2012\/0266(COD)<\/a>; 2012\/0267(COD)<\/a><\/span><\/p>\n Safer medical devices: MEPs strike deal with Council<\/span><\/a><\/p>\n![\"Risultati](\"http:\/\/www.uniteis.com\/dw\/wp-content\/uploads\/2015\/06\/bruxelles.jpg\")
have approved more stringent regulations in terms of safety also on in vitro diagnostic medical devices, used in pregnancy and DNA tests.
\nBoth texts have already been informally agreed with the EU Council of Ministers. \u201cThis is the final version of the document \u2013 comments Vincenzo Salvatore, Of Counsel of BonelliErede \u2013 which will go into the Official Gazette in the coming weeks. The first element of novelty is that before the matter used to be regulated by directives, now it will be regulated by regulations and we will have uniform rules in all the Member States<\/strong> \u2013 continues Salvatore \u2013 moreover simplifies the regulatory framework<\/strong>\u201c. Everyone will apply the same rules. \u201cThe metal-to-metal hip scandal has highlighted the weaknesses of the current system. We have therefore introduced stricter requirements for the bodies that authorize medical devices and will insist on particularly high-risk devices<\/strong>, such as implants, joint replacements or insulin pumps, are subject to additional expert assessments before they are authorised,\u201d said medical device rapporteur Glenis Willmott (S&D, UK).<\/p>\n
\nSalvatore underlines that each device will also have an identification number which will trace the operation of the device throughout its "life".
\nThe approved standards provide for:<\/p>\n\n
![\"Risultati](\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/thumb\/9\/91\/Europarl_logo.svg\/1280px-Europarl_logo.svg.png\"){kind=logo}
A separate law will also ensure that the new rules will also apply to in vitro diagnostic medical devices<\/strong>, i.e. those not in direct contact with the patient, but which provide health information, such as HIV, DNA or blood analysis devices. \u201cWe have learned the lesson from scandals such as the one of defective breast implants,\u201d said the rapporteur of the text on in vitro diagnostic medical devices, Peter Liese (EPP, Ge). \u201cThere have also been problems in other areas, for example with stents implanted in the brain or unreliable HIV tests. The new regulation is good for patients, it spells an end to fraudulent and suspicious manufacturers and thus also strengthens reputable manufacturers,\u201d he added.
\nFinally, the legislation requires Member States to inform patients about the consequences of DNA tests. \u201cIt is important that Member States fulfill this obligation. We will be very vigilant on this matter\u201d, said rapporteur Liese.<\/p>\n