Dental Tribune Asia Pacific No. 6, 2016

03 Dental Tribune Asia Pacific Edition | 6/2016 WORLD NEWS EU reaches deal over medical devices regulation By DTI BRUSSELS, Belgium: The European Parliament and the Council of the European Union have announced a breakthrough in negotiations concerning the overhaul of med- ical device legislation. After al- most four years, the EU bodies have agreed on a new system of quality and safety regulations af- fecting all medical device manu- facturers. The rules are expected to be adopted by early 2017. Essentially, all devices will have to undergo more thorough assessment of safety and perfor- mance before they can be sold on the European market. Control processes are to be radically rein- forced, aimed at giving European patients and consumers rapid ac- cess to innovative, cost-effective devices. According to the Euro- pean Commission, manufactur- ers shall benefit from clearer rules, easier trading between EU countries and an equal competi- tive environment that excludes those who do not comply with the legislation. The new regulations take particular account of the spe- cific needs of the many small and medium-sized manufacturers in this segment. The main elements of the law include wider and clearer scope for EU legislation. Software, instru- ments, apparatus, appliances and implants will all qualify as medi- cal devices and be subject to the new safety and performance re- quirements. According to the press release, the regulations will help manufacturers to improve their devices continuously based on the latest clinical data and thereby maintain a high standard of qual- ity. A central database will give manufacturers and patients all re- levant information, such as certif- icates and clinical investigations. Otherelementsincludestronger supervision of independent as- sessment bodies by national au- thorities, as well as greater power and obligations for these assess- ment bodies, to ensure thorough testing and regular checks. Manu- facturers should expect unan- nounced factory inspections and sample testing of devices that are already on the market. In addition, the regulations are in- tended to establish clearer rights and responsibilities for manu- facturers, importers and distri- butors, which will apply also to diagnostic services and Internet sales; as well as better traceability of devices throughout the supply chain owing to a unique identi- fication number. Finally, patients participating in clinical investiga- tions will be better protected. According to the Council of the EU press release, the new rules are aimed at ensuring that medi- cal devices and in vitro diagnostic medical devices are safe in two ways: strengthening the rules on releasing devices to the market and tightening surveillance once they are available. Furthermore, the agreement seeks to ensure that patients have timely access to innovative health care solu- tions. For dental dealers, the regula- tions might jeopardise existing agreements if manufacturers are unable to achieve the level of quality that the new body re- quires. Furthermore, dental organi- sations will be forced to cancel preferred supplier arrangements and look elsewhere for partners. The next steps In mid-June, the Council of the EU’s Permanent Representa- tives Committee is expected to endorse the agreement, while the European Council and the parlia- ment will probably follow by the end of the year after a thorough review process. The new regula- tions will apply three years after entry into force. NOW AS A FLOW! Tetric ® N-Ceram Bulk Fill The efficient posterior composite P ATENTED L IGHT INITI A T O R Ivocerin ® Tetric® N-Flow Bulk Fill flowable Tetric® N-Ceram Bulk Fill sculptable * Compared with Tetric ® N-Flow and Tetric ® N-Ceram Data available on request. www.ivoclarvivadent.com Ivoclar Vivadent AG Bendererstr. 2 | 9494 Schaan | Liechtenstein | Tel.: +423 235 35 35 | Fax: +423 235 33 60 on time* and achieve amazing results 55% Save AD Bendererstr. 2 | 9494 Schaan | Liechtenstein | Tel.: +4232353535 | Fax: +4232353360

Dental Tribune Asia Pacific No. 6, 2016

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