Medical devices, from spring 2017 they change the rules

From syringes to contact lenses, even aesthetic ones; from blood products to reagents for diagnosis; by electronic diagnostic equipment pacemakers: spanning all medical devices the two EU regulations - respectively is "classical" devices and in vitro diagnostic IDV - who send in the attic the current EU directives (385/90, 42/92, 79 / 98 and 47/2007) and vigeranno in spring 2017, directly operating in 28 member states, without the need to "Italic" implementing decrees. Moreover, each member state will have 3 years to adapt, and 5 for IDV. The first draft was ready in 2012 to go into effect in 2015 but the debate, intense, brought from 80 to 360 pages, now to the 28 member states. Change important rules: no criteria for approval by notified bodies, but the controls on the latter, so far belonging to national authorities and tomorrow "European."

The Dm are divided into three classes, the first - non-invasive - no need for approval of the notified bodies except where production occurs in clean room environments; for the other classes the producer turns to notified bodies, ten ones operating in Italy, including the National Institute of Health, 80 accredited EU. Second and third class include invasive or implantable devices that remain fixed in place after the procedure for 30 days and on active implantable (with an energy source). It needed a European register to make order, especially in an Italy which alone has a market equal to one tenth of that of the European Union - 10 billion euros compared with 100 and 140 against America - and 4500 large and small producers. As explained by Vincenzo Salvatore Professor of Community law at the University of Insubria and of-counsel of the study Bonelli Heir to the conference sponsored by Aboutpharma in Milan, some "bogeys" initials were not introduced: for example, no control pre authorization system Use type, more suitable to the drugs (which have longer patent life). Remain the notified bodies, questions authorization to the latter, it remains the CE mark.

But then will Brussels to assess the competence of bodies to take measures to evaluate efficacy and safety of the devices. For high-risk devices, the manufacturer must produce a periodical report on safety, manufacturers of implantable should carry out an additional monitoring. At the EU Commission already to 6 months after entry into force of the regulation will be sworn in on Medical Device Coordination Group which may request additional information to the manufacturer to those provided to notified bodies. The manufacturer must appoint a qualified person to ensure compliance with the requirements requested by the regulations. Notified bodies may make inspections to verify compliance of the production cycle. Another watchword traceability: Each device will be assigned an identification number (Udi) that follow you all stages of the life cycle. Salvatore D'Acunto, Head of Health & Cosmetic of the Internal Market Directorate in Brussels explains other innovations, "which can be summarized in four words: health, law, society, Europe."

There will be greater public protection through eg 'more rigorous premarketing controls that will not need prior authorization, a process for non-medical aesthetic devices, organic management and controlled clinical data on the drug trials model, unique identification number ; the patient may have information about what was implanted in her body because of implantable devices will be accompanied by an implant card. Finally, nell'istituenda Eudamed European database will enter the information on the devices with safety rules implantable Class III and rules protecting the patient in the event of damage. " Brussels reserves eighty delegated acts and lead to integrate and standardize the text. But Europe seems far away, the newspaper of the producers, as reported by Francesco Conti Medtronic responsible for institutional business. The regional health agencies do not always rely on the quality of the tenders, what counts is the price, "and even in a region of the races have been deserted for excessive downward. It lacks a national program. " There would be national Consip, "which is also attentive to issues of Health Technology Assessment and the transparency in the process routes of the races." But apparently it is not loved in all the provincial capitals.

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