Kudzoreredza kuvimba mumidziyo yekurapa: Chirongwa Chekuita mushure mekunyomba kwePIP kunosimbisa kutonga muEurope

Musi wa20 Chikumi, the EPSCO Council yakakurukura zviito zvakabatana zvakatorwa neEuropean Commission uye nyika dzenhengo kudzoreredza chivimbo zvichitevera kunyomba kwemazamu akaremara ma implants akagadzirwa nekambani yeFrance PIP. Aya matanho akabatanidzwa muChirongwa cheJoint for Immediate Actions pasi pemutemo uripo weMedical Devices (iyo inonzi PIP Joint Action Plan) yakabvumirana muna 2012 (Ona IP/12/119).

"Vatengi vakachengeteka nhasi kupfuura zvavaive pakawanikwa kunyomba kwePIP," akadaro Consumer Policy Commissioner Neven Mimica. “Nekuda kwekubatana kwepedyo pakati penyika dzenhengo neEuropean Commission, mitemo yanhasi pamidziyo yekurapa inotevedzwa zvirinani. Isu takabudirira kunyanya kusimbisa kutonga kwemitumbi yakaziviswa. Dzimwe gadziriso dzakakosha, zvisinei, dzinoda hwaro hwemutemo hwakasimbiswa. Ndosaka ndakadaidza nyika dziri nhengo kuti dzisvike pachibvumirano chezvematongerwo enyika gore rino risati rapera kuitira kuti zvibvumidzwe kukurumidza kutorwa kwegwaro rakakosha iri.. "

Kunyomba kwePIP kwakajekesa kuti kuvandudzwa kwekukurumidza mukutariswa kwemidziyo yekurapa kwaidiwa. Ndosaka European Commission nenyika dziri nhengo dzakabvumirana paAction Plan ine chinangwa chekuvandudza hutongi pahwaro hwemutemo uripo. Inotarisa pazvikamu zvina zvakakosha: kushanda kwemitumbi yakaziviswa; kutariswa kwemusika; kurongeka muminda yekungwarira; kutaurirana uye kubuda pachena.

Kubudirira kukuru pasi peJoint Action Plan

Hurongwa uhu hwakakonzera kufambira mberi kwakanyanya, kunyanya munzvimbo dzinotevera:

• Kubva paKomisheni Yekuita Regulation (EU) No 920/2013 ye2013 ichijekesa maitiro. kusangana nemitumbi inoziviswa, nyika dzenhengo dzine kuongororwazve zvikwaniriso uye chiyero chezviitwa zvavo miviri yakaziviswa. Izvi zvakakonzera kururamisa matanho kana kuganhurirwa muchikamu chezviitiko zvemitumbi yakaziviswa munyika dze8.

• Pakazosvika May 2014, nokuzvidira pamwe chete audits yemasangano akaziviswa nezvikwata zvinosanganisira vaongorori vanobva kunhengo dzakati wandei uye Komisheni yakaitwa munyika makumi maviri nembiri kubva makumi maviri nenhatu dzine masangano akazivisa. Kuongorora kwekupedzisira munyika yasara kwakatorongwa. Ongororo iyi yakakonzera kucherechedzwa kwematambudziko munzira iyo mitumbi yakaziviswa yakashanda. Pakaonekwa kukanganisa kukuru, danho rekukurumidza rekugadzirisa rakaitwa, kusanganisira kumbomira kana kudzikamisa nzvimbo yezviitwa zveboka rakaziviswa rine chekuita. Mune imwe nguva, mutumbi wakaziviswa hauchakwanisa kuburitsa zvitupa. Pazvaidiwa, kuongororwazve kwezvitupa zvese zvakapihwa kwakakumbirwa. Kune rimwe boka rakaziviswa nezvezvitupa 22 zvakatariswa, makumi mana nevashanu zvakamiswa basa uye gumi nevasere vakabviswa. 23-689 maodhita akadaro anofanooneswa 45.

PIP yakaratidza kushaya simba mukungwarira kwaivepo muhurongwa. The Action Plan inosimbisa hurongwa uhu nekukurudzira kuti masangano anoziviswa aite maodhita asina kuziviswa yevagadziri. Masangano akaziviswa azivisa kuti ave kuita kana kuti ari mushishi yekuparura ongororo yakadai. Nekudaro, hapana ruzivo rwakavimbika rwuripo kusvika pari zvino pahuwandu hwekuongororwa kusati kwaziviswa kana mhedzisiro yavo.

pamwedzi kungwarira teleconferences nenhengo dzenhengo, dzinotungamirwa neKomisheni masevhisi, zvave kuitika uye zviri kuvandudza kudyidzana pakati penhengo dzenhengo. Mhosva dzinopfuura makumi manomwe dzakaunzwa kuti dzibatanidzwe. Uye zvakare, iyo Commission Joint Research Center yatanga kuita ongorora mafambiro pazviitiko.

Komisheni yeVashandi Working Document yakakurukurwa muEPSCO Council ine ongororo yakadzama yezvinhu izvi pamwe nebasa rekuwedzera rinobva muhurongwa hwekuita seCommendation Recommendation pakushandiswa kweiyo nzira yekuteedzera michina yekurapa yakagamuchirwa muna Kubvumbi 2013, ichienderera mberi. nhaurirano yekuvandudza maregisheni ezvigadzirwa, nyika dzenhengo dzinoshuma nezvezviitiko zvekuongorora musika sehwaro hwekuwedzera kuvandudzwa, kana nhaurirano pamusoro pemishumo yezviitiko kubva kuvarapi nevarwere.

Ongororo iyi inoratidza kuti pane zvimwe zvikamu zveJoint Action Plan kufambira mberi kwave kushoma uye kuenderera mberi basa kwakakosha kusvika mutemo mutsva unotanga kushanda. Izvi zvinonyanya kunetsa:

• Sangano rekuongorora kusina kuziviswa uye kushanda kwavo;

• kuvandudzwa kwekunzwisisa kwakafanana kwekutarisa kwemusika uye zvirinani kurongeka uye kutaurirana pane yekuongorora data;

• ongororo yemashandisirwo emanyorero ekupa data uye kuona matambudziko kwenguva refu nemidziyo;

• kuzivikanwa kwemaitiro ekuona masaini, maitiro uye kuwedzera kwezviitiko zvakanyanya zvinobudirira zvichibva pane JRC purojekiti ichaunzwa pakati pe2014, uye;

• ongororo nenyika dzenhengo nezvekudiwa, nemikana yekuronga zvirongwa zvekudzidzisa vezera.

Kuitwa kweJoint Plan kwave kubudirira. Zvisinei, inhevedzano yezviyero zvenguva pfupi zvakagadzirirwa kuwedzera kugona kwemutemo uripo. Kugadziriswa kwenguva refu kunoda kunyatsoongororwa kwemutemo.Kugamuchirwa kweMitemo mitsva yakarongwa kunodiwa kugadzirisa nyaya dzakati kuti dzasara. Izvi zvinonyanya kuenderana ne:

• Kuwanda kwemutemo,

• utongi hwehurongwa uye kujeka kwayo,

• zvimwe zvisungo zvemitumbi yakaziviswa, kunyanya zvine chekuita nekumanikidzwa kusinga ziviswe maodhisheni,

• kuongororwa kwekliniki,

• kupatsanurwa kwengozi yemidziyo uye kuchengetedza uye kuita zvinodiwa,

• zvisungo zvevashandi vehupfumi,

• kutaurwa kwezviitiko zvevashandisi nevarwere kuVane masimba,

• zvimwe zvine chekuita nekurinda sisitimu uye kutariswa kwemusika,

• basa nekushanda kwedatabase Eudamed uye kuwana kwemitumbi yakaziviswa kuEudamed, uye;

• iyo traceability yemidziyo.

Imwe neimwe yeaya mapoinzi yakakosha pakuita kuti murwere uye mutengi achengetedzeke.

Kuti uwane mamwe mashoko, tinya pano.

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