{"id":116474,"date":"2026-08-18T11:52:12","date_gmt":"2026-08-18T09:52:12","guid":{"rendered":"https:\/\/amcham.com.al\/komentet-e-dhomes-amerikane-per-projektligjin-per-pajisjet-mjekesore\/"},"modified":"2026-08-18T11:55:03","modified_gmt":"2026-08-18T09:55:03","slug":"komentet-e-dhomes-amerikane-per-projektligjin-per-pajisjet-mjekesore","status":"publish","type":"post","link":"https:\/\/amcham.com.al\/sq\/komentet-e-dhomes-amerikane-per-projektligjin-per-pajisjet-mjekesore\/","title":{"rendered":"Komentet e Dhom\u00ebs Amerikane p\u00ebr Projektligjin \u201cP\u00ebr Pajisjet Mjek\u00ebsore\u201d"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">N\u00eb kuad\u00ebr t\u00eb procesit t\u00eb konsultimit publik p\u00ebr projektligjin <strong>\u201cP\u00ebr Pajisjet Mjek\u00ebsore\u201d<\/strong> dhe projektligjin <strong>\u201cP\u00ebr Pajisjet Mjek\u00ebsore Diagnostikuese In Vitro\u201d,<\/strong> t\u00eb publikuara m\u00eb 20 korrik 2026, Dhoma Amerikane e Tregtis\u00eb n\u00eb Shqip\u00ebri (AmCham Albania), pas konsultimit me an\u00ebtar\u00ebt e saj, paraqet n\u00eb vijim disa komente dhe rekomandime me synim p\u00ebrmir\u00ebsimin e qart\u00ebsis\u00eb, koherenc\u00ebs dhe zbatueshm\u00ebris\u00eb s\u00eb kuadrit t\u00eb propozuar.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">AmCham vler\u00ebson pozitivisht orientimin e t\u00eb dy projektligjeve drejt p\u00ebrafrimit me <strong>Rregulloren (BE) 2017\/745<\/strong> p\u00ebr pajisjet mjek\u00ebsore dhe <strong>Rregulloren (BE) 2017\/746<\/strong> p\u00ebr pajisjet mjek\u00ebsore diagnostikuese in vitro. Duke qen\u00eb se t\u00eb dy aktet p\u00ebrb\u00ebjn\u00eb nj\u00eb kuad\u00ebr rregullator t\u00eb nd\u00ebrlidhur, vler\u00ebsojm\u00eb se \u00ebsht\u00eb e r\u00ebnd\u00ebsishme q\u00eb, p\u00ebrve\u00e7 p\u00ebrafrimit material me acquis t\u00eb BE-s\u00eb, t\u00eb garantohet edhe <strong>koherenca terminologjike, strukturore dhe institucionale<\/strong> nd\u00ebrmjet tyre.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>I. \u00c7\u00cbSHTJE T\u00cb P\u00cbRBASHK\u00cbTA P\u00cbR T\u00cb DY PROJEKTLIGJET<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. Publikimi i plot\u00eb i dokumentacionit q\u00eb shoq\u00ebron projektligjet dhe zgjatja e afatit t\u00eb konsultimit publik<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nga shqyrtimi i materialeve t\u00eb publikuara n\u00eb Regjistrin Elektronik p\u00ebr Njoftimet dhe Konsultimet Publike, konstatohet se dokumentacioni q\u00eb duhet t\u00eb shoq\u00ebroj\u00eb projektligjet nuk rezulton i publikuar n\u00eb m\u00ebnyr\u00eb t\u00eb plot\u00eb.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">N\u00eb m\u00ebnyr\u00eb t\u00eb ve\u00e7ant\u00eb, p\u00ebr nj\u00eb shqyrtim t\u00eb plot\u00eb t\u00eb projektligjeve, krahas tekstit t\u00eb tyre integral dhe shtojcave p\u00ebrkat\u00ebse, \u00ebsht\u00eb e nevojshme t\u00eb jen\u00eb t\u00eb aksesueshme dokumentet shoq\u00ebruese, p\u00ebrfshir\u00eb <strong>Relacionin shpjegues, Raportin e Vler\u00ebsimit t\u00eb Ndikimit Rregullator (RIA)<\/strong> dhe, n\u00eb rastin konkret, duke qen\u00eb se projektligjet synojn\u00eb p\u00ebrafrimin me acquis t\u00eb Bashkimit Evropian, edhe <strong>Tabel\u00ebn e P\u00ebrputhshm\u00ebris\u00eb<\/strong> me aktet p\u00ebrkat\u00ebse t\u00eb BE-s\u00eb.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Mungesa e k\u00ebtyre dokumenteve kufizon mund\u00ebsin\u00eb e pal\u00ebve t\u00eb interesuara p\u00ebr t\u00eb vler\u00ebsuar n\u00eb m\u00ebnyr\u00eb t\u00eb plot\u00eb arsyetimin e nd\u00ebrhyrjeve t\u00eb propozuara, ndikimet e pritshme rregullatore, nivelin dhe m\u00ebnyr\u00ebn e p\u00ebrafrimit me Rregulloret (BE) 2017\/745 dhe 2017\/746, si dhe eventualisht devijimet apo p\u00ebrshtatjet e b\u00ebra n\u00eb kuadrin komb\u00ebtar.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Rekomandim:<\/strong> K\u00ebrkojm\u00eb publikimin e plot\u00eb t\u00eb dokumentacionit shoq\u00ebrues p\u00ebr t\u00eb dy projektligjet, p\u00ebrfshir\u00eb tekstet integrale me <strong>shtojcat<\/strong>, <strong>Relacionin shpjegues, RIA-n dhe Tabelat e P\u00ebrputhshm\u00ebris\u00eb me acquis t\u00eb Bashkimit Evropian. <\/strong>Nj\u00ebkoh\u00ebsisht, duke qen\u00eb se k\u00ebto dokumente jan\u00eb thelb\u00ebsore p\u00ebr nj\u00eb shqyrtim real dhe teknik t\u00eb projektligjeve, k\u00ebrkojm\u00eb <strong>zgjatjen e afatit t\u00eb konsultimit publik<\/strong>, duke e llogaritur nj\u00eb periudh\u00eb t\u00eb arsyeshme konsultimi nga momenti i publikimit t\u00eb plot\u00eb t\u00eb dokumentacionit p\u00ebrkat\u00ebs.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. P\u00ebrjashtim proporcional nga k\u00ebrkesa e gjuh\u00ebs shqipe p\u00ebr pajisjet e destinuara ekskluzivisht p\u00ebr p\u00ebrdorim profesional<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Me q\u00ebllim leht\u00ebsimin e aksesit n\u00eb koh\u00eb t\u00eb pacient\u00ebve n\u00eb teknologji mjek\u00ebsore inovative, duke ruajtur nj\u00ebkoh\u00ebsisht nj\u00eb nivel t\u00eb lart\u00eb t\u00eb siguris\u00eb s\u00eb pacientit, AmCham Albania rekomandon <strong>vendosjen e nj\u00eb p\u00ebrjashtimi proporcional q\u00eb lejon q\u00eb udh\u00ebzimet p\u00ebr p\u00ebrdorim dhe informacionet e tjera q\u00eb shoq\u00ebrojn\u00eb pajisjen mjek\u00ebsore, kur jan\u00eb t\u00eb destinuara ekskluzivisht p\u00ebr profesionist\u00ebt e kujdesit sh\u00ebndet\u00ebsor, t\u00eb ofrohen n\u00eb gjuh\u00ebn angleze,<\/strong> me kusht q\u00eb <strong>institucioni sh\u00ebndet\u00ebsor marr\u00ebs t\u00eb ket\u00eb r\u00ebn\u00eb dakord t\u00eb pranoj\u00eb k\u00ebt\u00eb dokumentacion n\u00eb anglisht.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Ndryshimi ligjor i propozuar<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u201c<em>Kur udh\u00ebzimet p\u00ebr p\u00ebrdorim dhe informacionet e tjera q\u00eb shoq\u00ebrojn\u00eb pajisjen mjek\u00ebsore jan\u00eb t\u00eb destinuara ekskluzivisht p\u00ebr profesionist\u00ebt e kujdesit sh\u00ebndet\u00ebsor dhe pajisja mjek\u00ebsore furnizohet vet\u00ebm te nj\u00eb institucion sh\u00ebndet\u00ebsor q\u00eb ka r\u00ebn\u00eb dakord t\u00eb marr\u00eb k\u00ebt\u00eb dokumentacion n\u00eb gjuh\u00ebn angleze, udh\u00ebzimet p\u00ebr p\u00ebrdorim dhe informacionet e tjera mund t\u00eb ofrohen n\u00eb anglisht<\/em>.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Argumentet kryesore<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>P\u00ebrafrimi me zhvillimet legjislative t\u00eb BE-s\u00eb:<\/strong> Propozimi \u00ebsht\u00eb plot\u00ebsisht <strong>n\u00eb p\u00ebrputhje me propozimin e Komisionit Evropian COM (2025)1023,<\/strong> ku citohet: \u201c<em>Kur nj\u00eb pajisje vihet n\u00eb dispozicion ekskluzivisht p\u00ebr p\u00ebrdorues profesionist\u00eb, informacioni duhet t\u00eb jepet n\u00eb gjuh\u00ebn angleze.\u201d<\/em><\/li>\n\n\n\n<li><strong>Praktika e konsoliduar n\u00eb BE:<\/strong> Disa shtete an\u00ebtare t\u00eb Bashkimit Evropian kan\u00eb miratuar tashm\u00eb <strong>k\u00ebrkesa proporcionale gjuh\u00ebsore, duke lejuar dokumentacionin n\u00eb gjuh\u00ebn angleze p\u00ebr pajisjet mjek\u00ebsore t\u00eb destinuara ekskluzivisht p\u00ebr p\u00ebrdorim profesional<\/strong> brenda institucioneve sh\u00ebndet\u00ebsore. Kjo qasje merr n\u00eb konsiderat\u00eb faktin se pajisjet mjek\u00ebsore t\u00eb specializuara p\u00ebrdoren vet\u00ebm nga profesionist\u00eb sh\u00ebndet\u00ebsor\u00eb t\u00eb kualifikuar n\u00eb m\u00ebnyr\u00eb t\u00eb p\u00ebrshtatshme, t\u00eb cil\u00ebt marrin trajnim nga prodhuesi dhe dokumentacion teknik kryesisht n\u00eb gjuh\u00ebn angleze. <strong>Shtete si Lituania, Letonia dhe Estonia kan\u00eb zbatuar dispozita t\u00eb tilla,<\/strong> duke treguar se kjo qasje \u00ebsht\u00eb praktike dhe e pajtueshme me nj\u00eb nivel t\u00eb lart\u00eb t\u00eb siguris\u00eb s\u00eb pacientit. P\u00ebr shkak t\u00eb tregjeve t\u00eb tyre relativisht t\u00eb vogla t\u00eb kujdesit sh\u00ebndet\u00ebsor, k\u00ebto vende p\u00ebrb\u00ebjn\u00eb <strong>shembuj ve\u00e7an\u00ebrisht t\u00eb r\u00ebnd\u00ebsish\u00ebm p\u00ebr Shqip\u00ebrin\u00eb<\/strong> dhe ilustrojn\u00eb se si k\u00ebrkesat proporcionale gjuh\u00ebsore mund t\u00eb p\u00ebrmir\u00ebsojn\u00eb aksesin n\u00eb teknologji mjek\u00ebsore inovative pa cenuar sigurin\u00eb e pacientit.<\/li>\n\n\n\n<li><strong>Aksesi n\u00eb inovacion:<\/strong> <strong>P\u00ebrkthimi i detyruesh\u00ebm i udh\u00ebzimeve p\u00ebr p\u00ebrdorim (IFU) dhe dokumentacionit shoq\u00ebrues krijon nj\u00eb barr\u00eb joproporcionale<\/strong> p\u00ebr teknologjit\u00eb shum\u00eb t\u00eb specializuara q\u00eb furnizohen n\u00eb volume t\u00eb ul\u00ebta. Gjat\u00eb procesit legjislativ n\u00eb Lituani, u pranua se <strong>kostot e p\u00ebrkthimit mund t\u00eb vonojn\u00eb ose t\u00eb dekurajojn\u00eb futjen n\u00eb tregje m\u00eb t\u00eb vogla t\u00eb teknologjive inovative,<\/strong> si neuromodulimi, neurostimulimi dhe kirurgjia e drejtuar nga imazheria, duke kufizuar n\u00eb fund aksesin e pacient\u00ebve n\u00eb opsione t\u00eb avancuara trajtimi.<\/li>\n\n\n\n<li><strong>Siguria e pacientit:<\/strong> Profesionist\u00ebt e kujdesit sh\u00ebndet\u00ebsor q\u00eb p\u00ebrdorin k\u00ebto teknologji marrin nga prodhuesi <strong>trajnim, certifikim, dokumentacion teknik dhe trajnim p\u00ebr programet kompjuterike, kryesisht n\u00eb gjuh\u00ebn angleze.<\/strong> Udh\u00ebzimet klinike nd\u00ebrkomb\u00ebtare, literatura shkencore dhe nd\u00ebrfaqet e pajisjeve jan\u00eb gjithashtu kryesisht n\u00eb anglisht. N\u00eb t\u00eb kund\u00ebrt, <strong>vonesat n\u00eb p\u00ebrkthim mund t\u00eb b\u00ebjn\u00eb q\u00eb spitalet t\u00eb mb\u00ebshteten n\u00eb udh\u00ebzime p\u00ebrdorimi t\u00eb p\u00ebrkthyera, por t\u00eb vjetruara,<\/strong> n\u00eb vend t\u00eb dokumentacionit m\u00eb t\u00eb fundit t\u00eb miratuar nga prodhuesi.<\/li>\n\n\n\n<li><strong>Udh\u00ebzimet elektronike p\u00ebr p\u00ebrdorim (eIFU):<\/strong> AmCham Albania inkurajon gjithashtu <strong>adoptimin progresiv t\u00eb udh\u00ebzimeve elektronike p\u00ebr p\u00ebrdorim (eIFU),<\/strong> n\u00eb p\u00ebrputhje me kuadrin rregullator evropian t\u00eb zbatuesh\u00ebm, p\u00ebrfshir\u00eb Rregulloren e Komisionit (BE) nr. 207\/2012 dhe zhvillimet e ardhshme n\u00eb legjislacionin e BE-s\u00eb p\u00ebr pajisjet mjek\u00ebsore. P\u00ebrdorimi i eIFU-ve <strong>p\u00ebrmir\u00ebson kontrollin e versioneve, mund\u00ebson akses t\u00eb menj\u00ebhersh\u00ebm n\u00eb informacionin m\u00eb t\u00eb p\u00ebrdit\u00ebsuar t\u00eb miratuar nga prodhuesi, leht\u00ebson komunikimin e shpejt\u00eb t\u00eb njoftimeve t\u00eb siguris\u00eb dhe p\u00ebrdit\u00ebsimeve<\/strong> t\u00eb programeve kompjuterike, mb\u00ebshtet sigurin\u00eb kibernetike duke siguruar shp\u00ebrndarjen n\u00eb koh\u00eb t\u00eb informacionit t\u00eb lidhur me sigurin\u00eb, redukton barr\u00ebn administrative dhe konsumin e letr\u00ebs dhe kontribuon n\u00eb q\u00ebndrueshm\u00ebrin\u00eb mjedisore. Nd\u00ebrsa sistemet sh\u00ebndet\u00ebsore vijojn\u00eb t\u00eb digjitalizohen, <strong>njohja m\u00eb e gjer\u00eb e eIFU-ve do t\u00eb mb\u00ebshteste akses m\u00eb efikas dhe t\u00eb q\u00ebndruesh\u00ebm <\/strong>n\u00eb dokumentacionin e pajisjeve mjek\u00ebsore n\u00eb t\u00eb gjith\u00eb sektorin e kujdesit sh\u00ebndet\u00ebsor.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Rekomandim<\/strong>: AmCham Albania rekomandon <strong>p\u00ebrfshirjen e ndryshimit t\u00eb propozuar n\u00eb t\u00eb dy projektligjet dhe shqyrtimin e njohjes s\u00eb udh\u00ebzimeve elektronike p\u00ebr p\u00ebrdorim (eIFU).<\/strong> Kjo do t\u00eb krijonte nj\u00eb kuad\u00ebr rregullator modern, proporcional dhe miq\u00ebsor ndaj inovacionit, t\u00eb harmonizuar me zhvillimet e legjislacionit t\u00eb BE-s\u00eb, duke ruajtur nj\u00ebkoh\u00ebsisht standardet m\u00eb t\u00eb larta t\u00eb siguris\u00eb s\u00eb pacientit.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. Koherenca terminologjike dhe strukturore nd\u00ebrmjet dy projektligjeve<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Duke qen\u00eb se projektligjet synojn\u00eb t\u00eb implementojn\u00eb dy rregullore t\u00eb s\u00eb nj\u00ebjt\u00ebs arkitektur\u00eb rregullatore evropiane, v\u00ebrejm\u00eb disa <strong>dallime terminologjike dhe strukturore.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Projektligji p\u00ebr pajisjet mjek\u00ebsore p\u00ebrdor termin <strong>\u201cShtojc\u00eb\u201d,<\/strong> nd\u00ebrsa ai p\u00ebr pajisjet diagnostikuese in vitro p\u00ebrdor <strong>\u201cAneks\u201d.<\/strong> Gjithashtu, autoriteti kompetent referohet me formulime t\u00eb ndryshme, p\u00ebrkat\u00ebsisht <strong>\u201cstruktura p\u00ebrgjegj\u00ebse\u201d<\/strong> dhe <strong>\u201cstruktura p\u00ebrgjegj\u00ebse p\u00ebr inspektimin e pajisjeve\u201d.<\/strong> Diferenca t\u00eb ngjashme konstatohen edhe n\u00eb formulimin e disa klauzolave horizontale.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nj\u00eb terminologji e unifikuar \u00ebsht\u00eb e r\u00ebnd\u00ebsishme jo vet\u00ebm nga pik\u00ebpamja e teknik\u00ebs legjislative, por edhe p\u00ebr t\u00eb shmangur interpretime t\u00eb ndryshme gjat\u00eb zbatimit nga operator\u00ebt ekonomik\u00eb dhe autoritetet kompetente.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Rekomandim<\/strong>: Sugjerojm\u00eb <strong>harmonizimin e terminologjis\u00eb dhe struktur\u00ebs<\/strong> <strong>nd\u00ebrmjet dy projektligjeve,<\/strong> aty ku konceptet dhe institucionet jan\u00eb t\u00eb nj\u00ebjta. N\u00eb ve\u00e7anti, rekomandojm\u00eb p\u00ebrdorimin e <strong>nj\u00eb termi unik p\u00ebr shtojcat\/anekset,<\/strong> identifikimin e qart\u00eb dhe uniform t\u00eb autoritetit kompetent dhe harmonizimin e dispozitave horizontale q\u00eb kan\u00eb t\u00eb nj\u00ebjtin funksion n\u00eb t\u00eb dy ligjet.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>II. PROJEKTLIGJI \u201cP\u00cbR PAJISJET MJEK\u00cbSORE\u201d<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">1. <strong>Vler\u00ebsim pozitiv p\u00ebr drejtimin e p\u00ebrafrimit me Rregulloren (BE) 2017\/745<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">AmCham vler\u00ebson pozitivisht faktin q\u00eb projektligji reflekton n\u00eb mas\u00eb t\u00eb konsiderueshme <strong>arkitektur\u00ebn dhe parimet themelore t\u00eb Rregullores (BE) 2017\/745,<\/strong> duke p\u00ebrfshir\u00eb k\u00ebrkesat p\u00ebr sigurin\u00eb dhe performanc\u00ebn, gjurmueshm\u00ebrin\u00eb, sistemin UDI, mbik\u00ebqyrjen pas vendosjes n\u00eb treg dhe detyrimet e operator\u00ebve ekonomik\u00eb.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ve\u00e7an\u00ebrisht pozitiv vler\u00ebsohet <strong>kalimi drejt nj\u00eb kuadri rregullator t\u00eb bazuar n\u00eb modelin aktual evropian,<\/strong> i cili krijon premisa p\u00ebr rritjen e siguris\u00eb s\u00eb pacient\u00ebve dhe p\u00ebr nj\u00eb mjedis m\u00eb t\u00eb parashikuesh\u00ebm p\u00ebr operator\u00ebt q\u00eb veprojn\u00eb n\u00eb tregun shqiptar.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">N\u00eb k\u00ebt\u00eb drejtim, rekomandojm\u00eb q\u00eb gjat\u00eb finalizimit t\u00eb projektligjit apo gjat\u00eb hartimit t\u00eb akteve n\u00ebnligjore t\u00eb ruhet sa m\u00eb shum\u00eb <strong>koherenca me konceptet, p\u00ebrkufizimet dhe mekanizmat e Rregullores (BE) 2017\/745, <\/strong>duke shmangur devijimet q\u00eb nuk mb\u00ebshteten n\u00eb nevoja specifike t\u00eb tregut shqiptar.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. Raporti me legjislacionin p\u00ebr p\u00ebrputhshm\u00ebrin\u00eb elektromagnetike<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Rregullorja (BE) 2017\/745<\/strong> p\u00ebrcakton shprehimisht raportin e saj me legjislacionin e Bashkimit Evropian p\u00ebr p\u00ebrputhshm\u00ebrin\u00eb elektromagnetike, duke e konsideruar kuadrin p\u00ebr pajisjet mjek\u00ebsore si legjislacion specifik p\u00ebr k\u00ebt\u00eb q\u00ebllim.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">N\u00eb projektligjin shqiptar konstatojm\u00eb <strong>munges\u00ebn e nj\u00eb dispozite ekuivalente<\/strong> q\u00eb t\u00eb p\u00ebrcaktoj\u00eb qart\u00eb raportin nd\u00ebrmjet k\u00ebrkesave t\u00eb projektligjit p\u00ebr pajisjet mjek\u00ebsore dhe legjislacionit komb\u00ebtar p\u00ebr p\u00ebrputhshm\u00ebrin\u00eb elektromagnetike.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">P\u00ebr pajisjet elektromjek\u00ebsore, p\u00ebrcaktimi i qart\u00eb i raportit nd\u00ebrmjet dy regjimeve \u00ebsht\u00eb i r\u00ebnd\u00ebsish\u00ebm p\u00ebr t\u00eb shmangur <strong>pasigurin\u00eb rregullatore, interpretimet e ndryshme dhe k\u00ebrkesat potencialisht t\u00eb mbivendosura<\/strong> gjat\u00eb vler\u00ebsimit t\u00eb konformitetit dhe mbik\u00ebqyrjes s\u00eb tregut.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Rekomandim<\/strong>: Sugjerojm\u00eb<strong> p\u00ebrfshirjen e nj\u00eb dispozite q\u00eb p\u00ebrcakton n\u00eb m\u00ebnyr\u00eb t\u00eb qart\u00eb raportin e projektligjit me legjislacionin shqiptar p\u00ebr p\u00ebrputhshm\u00ebrin\u00eb elektromagnetike<\/strong>, duke ndjekur logjik\u00ebn e <strong>Rregullores (BE) 2017\/745<\/strong> dhe duke e p\u00ebrshtatur referenc\u00ebn me legjislacionin shqiptar n\u00eb fuqi.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. Tregtimi, furnizimi dhe gjurmueshm\u00ebria deri te p\u00ebrdoruesi final<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">K\u00ebrkohet <strong>qart\u00ebsi m\u00eb e madhe lidhur me regjimin q\u00eb do t\u00eb zbatohet p\u00ebr furnizimin dhe tregtimin e pajisjeve mjek\u00ebsore<\/strong> drejt institucioneve sh\u00ebndet\u00ebsore, profesionist\u00ebve sh\u00ebndet\u00ebsor\u00eb dhe p\u00ebrdoruesve final\u00eb, ve\u00e7an\u00ebrisht n\u00eb kushtet kur projektligji i ri parashikon z\u00ebvend\u00ebsimin e kuadrit ekzistues p\u00ebr tregtimin e pajisjeve mjek\u00ebsore.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">N\u00eb t\u00eb nj\u00ebjt\u00ebn koh\u00eb, projektligji vendos nj\u00eb <strong>sistem t\u00eb gjer\u00eb gjurmueshm\u00ebrie<\/strong> n\u00ebp\u00ebrmjet identifikimit t\u00eb operator\u00ebve n\u00eb zinxhirin e furnizimit dhe sistemit UDI. P\u00ebr funksionimin efektiv t\u00eb k\u00ebtij sistemi \u00ebsht\u00eb e r\u00ebnd\u00ebsishme q\u00eb detyrimet t\u00eb mos p\u00ebrfundojn\u00eb vet\u00ebm n\u00eb nivelin e importuesit ose shp\u00ebrndar\u00ebsit, por t\u00eb <strong>p\u00ebrcaktohet qart\u00eb edhe roli i institucioneve sh\u00ebndet\u00ebsore dhe profesionist\u00ebve q\u00eb marrin dhe p\u00ebrdorin pajisjet.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Rekomandim<\/strong>: Sugjerojm\u00eb t\u00eb sqarohet n\u00eb projektligj ose n\u00eb aktet e tij zbatuese:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>cil\u00ebt operator\u00eb kan\u00eb t\u00eb drejt\u00eb t\u00eb furnizojn\u00eb kategori t\u00eb ndryshme pajisjesh<\/strong> drejtp\u00ebrdrejt te institucionet sh\u00ebndet\u00ebsore, profesionist\u00ebt dhe p\u00ebrdoruesit final\u00eb;<\/li>\n\n\n\n<li>n\u00ebse p\u00ebr kategori t\u00eb caktuara pajisjesh, n\u00eb var\u00ebsi t\u00eb klas\u00ebs s\u00eb rrezikut, k\u00ebrkohet nj\u00eb <strong>regjim i posa\u00e7\u00ebm autorizimi ose kushte specifike p\u00ebr furnizimin;<\/strong><\/li>\n\n\n\n<li><strong>detyrimet konkrete t\u00eb institucioneve sh\u00ebndet\u00ebsore dhe profesionist\u00ebve<\/strong> p\u00ebr ruajtjen e UDI-s\u00eb dhe t\u00eb informacionit t\u00eb nevojsh\u00ebm p\u00ebr gjurmueshm\u00ebri;<\/li>\n\n\n\n<li><strong>m\u00ebnyr\u00ebn e raportimit t\u00eb incidenteve, mosfunksionimeve, masave korrigjuese dhe t\u00ebrheqjeve nga tregu<\/strong> nga ana e p\u00ebrdoruesve profesional\u00eb; dhe<\/li>\n\n\n\n<li>p\u00ebr kategorit\u00eb e pajisjeve ku \u00ebsht\u00eb e nevojshme p\u00ebr sigurin\u00eb dhe vigjilenc\u00ebn, <strong>m\u00ebnyr\u00ebn e sigurimit t\u00eb gjurmueshm\u00ebris\u00eb s\u00eb pajisjes deri te pacienti, <\/strong>duke respektuar nj\u00ebkoh\u00ebsisht legjislacionin p\u00ebr mbrojtjen e t\u00eb dh\u00ebnave personale.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>P\u00ebrcaktimi i qart\u00eb i p\u00ebrgjegj\u00ebsive p\u00ebrgjat\u00eb gjith\u00eb zinxhirit do t\u00eb ndihmonte si mbrojtjen e pacientit, ashtu edhe reagimin efektiv n\u00eb rast t\u00eb incidenteve ose t\u00ebrheqjes s\u00eb nj\u00eb pajisjeje nga tregu.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4. Ruajtja gjat\u00eb periudh\u00ebs tranzitore e njohjes s\u00eb certifikimit FDA p\u00ebr pajisjet mjek\u00ebsore<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Projektligji i ri \u201cP\u00ebr Pajisjet Mjek\u00ebsore\u201d, n\u00eb nenin 14, pika 2, shkronja \u201ca\u201d, parashikon se, p\u00ebrpara vendosjes s\u00eb nj\u00eb pajisjeje n\u00eb treg, importuesi duhet t\u00eb verifikoj\u00eb q\u00eb <strong>pajisja mban markimin CE dhe se p\u00ebr t\u00eb \u00ebsht\u00eb hartuar deklarata EU e konformitetit.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nd\u00ebrkoh\u00eb, legjislacioni aktual, i ndryshuar me ligjin nr. 21\/2020, <strong>njeh edhe certifikimin e l\u00ebshuar nga Administrata e Ushqimit dhe Barnave e Shteteve t\u00eb Bashkuara t\u00eb Amerik\u00ebs (FDA) si nj\u00eb alternativ\u00eb<\/strong> p\u00ebr konfirmimin e konformitetit t\u00eb pajisjeve mjek\u00ebsore. Konkretisht, ndryshimet e b\u00ebra n\u00eb nenin 17 t\u00eb ligjit nr. 89\/2014 parashikojn\u00eb konfirmimin e konformitetit n\u00ebp\u00ebrmjet dokumentit t\u00eb certifikimit FDA dhe njohjen e markimit CE ose certifikimit FDA.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">N\u00eb k\u00ebt\u00eb kuptim, projektligji i ri sjell nj\u00eb ndryshim t\u00eb r\u00ebnd\u00ebsish\u00ebm krahasuar me kuadrin aktual, pasi <strong>nuk rezulton t\u00eb ruaj\u00eb mund\u00ebsin\u00eb e njohjes s\u00eb certifikimit FDA<\/strong> si baz\u00eb p\u00ebr vendosjen e pajisjeve mjek\u00ebsore n\u00eb tregun shqiptar.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">AmCham Albania mb\u00ebshtet objektivin e p\u00ebrafrimit t\u00eb legjislacionit shqiptar me Rregulloren (BE) 2017\/745 dhe standardet e Bashkimit Evropian. Megjithat\u00eb, duke marr\u00eb n\u00eb konsiderat\u00eb se Shqip\u00ebria ndodhet ende n\u00eb procesin e an\u00ebtar\u00ebsimit n\u00eb Bashkimin Evropian, si dhe nevoj\u00ebn p\u00ebr t\u00eb ruajtur aksesin e tregut shqiptar dhe t\u00eb pacient\u00ebve n\u00eb teknologji t\u00eb avancuara mjek\u00ebsore, <strong>vler\u00ebsojm\u00eb se duhet t\u00eb konsiderohet ruajtja, p\u00ebr nj\u00eb periudh\u00eb tranzitore, e mund\u00ebsis\u00eb s\u00eb njohjes s\u00eb certifikimit FDA krahas markimit CE.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Heqja e k\u00ebsaj mund\u00ebsie <strong>mund t\u00eb kufizoj\u00eb aksesin n\u00eb pajisje mjek\u00ebsore inovative<\/strong> t\u00eb prodhuara dhe t\u00eb autorizuara p\u00ebr tregtim n\u00eb Shtetet e Bashkuara t\u00eb Amerik\u00ebs, t\u00eb cilat mund t\u00eb mos disponojn\u00eb ende markimin CE, pavar\u00ebsisht se jan\u00eb autorizuar sipas k\u00ebrkesave rregullatore t\u00eb FDA-s\u00eb.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Rekomandim:<\/strong> Sugjerojm\u00eb q\u00eb, gjat\u00eb periudh\u00ebs tranzitore deri n\u00eb an\u00ebtar\u00ebsimin e Shqip\u00ebris\u00eb n\u00eb Bashkimin Evropian, projektligji t\u00eb ruaj\u00eb mund\u00ebsin\u00eb e njohjes s\u00eb <strong>markimit CE dhe\/ose certifikimit\/autorizimit p\u00ebrkat\u00ebs t\u00eb FDA-s\u00eb<\/strong>, n\u00eb p\u00ebrputhje me parimin e parashikuar n\u00eb legjislacionin aktual.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Nj\u00eb dispozit\u00eb tranzitore e till\u00eb do t\u00eb mund\u00ebsonte <strong>vijimin e aksesit n\u00eb pajisje mjek\u00ebsore t\u00eb autorizuara n\u00eb tregun amerikan, pa cenuar objektivin afatgjat\u00eb t\u00eb p\u00ebrafrimit t\u00eb plot\u00eb t\u00eb kuadrit shqiptar me acquis t\u00eb Bashkimit Evropian.<\/strong> N\u00eb t\u00eb nj\u00ebjt\u00ebn koh\u00eb, kushtet dhe dokumentacioni i nevojsh\u00ebm p\u00ebr njohjen e certifikimit\/autorizimit FDA mund t\u00eb p\u00ebrcaktohen qart\u00eb n\u00eb projektligj ose n\u00eb aktet n\u00ebnligjore p\u00ebrkat\u00ebse, duke garantuar <strong>k\u00ebrkesat e siguris\u00eb, gjurmueshm\u00ebris\u00eb, vigjilenc\u00ebs dhe mbik\u00ebqyrjes pas vendosjes n\u00eb treg.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>5. Dispozitat Tranzitore p\u00ebr Pajisjet \u201cLegacy\u201d (Legacy devices)<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Vler\u00ebsojm\u00eb t\u00eb nevojshme <strong>p\u00ebrfshirjen n\u00eb projektligj t\u00eb dispozitave t\u00eb qarta tranzitore p\u00ebr pajisjet mjek\u00ebsore (\u201clegacy devices\u201d)<\/strong> t\u00eb vendosura ligj\u00ebrisht n\u00eb treg sipas kuadrit t\u00eb m\u00ebparsh\u00ebm rregullator dhe q\u00eb jan\u00eb n\u00eb proces kalimi drejt k\u00ebrkesave t\u00eb kuadrit t\u00eb ri ligjor p\u00ebr pajisjet mjek\u00ebsore<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Aktualisht, projektligji <strong>nuk duket se parashikon nj\u00eb mekaniz\u00ebm t\u00eb qart\u00eb ligjor ose afate kalimtare<\/strong> p\u00ebr pajisjet q\u00eb mbulohen nga certifikata t\u00eb vlefshme t\u00eb l\u00ebshuara sipas Direktivave t\u00eb m\u00ebparshme t\u00eb BE-s\u00eb. Mungesa e k\u00ebtyre dispozitave mund t\u00eb krijoj\u00eb pasiguri ligjore p\u00ebr prodhuesit, p\u00ebrfaq\u00ebsuesit e autorizuar, importuesit, shp\u00ebrndar\u00ebsit, institucionet sh\u00ebndet\u00ebsore dhe autoritetet kompetente.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">P\u00ebr t\u00eb garantuar sigurin\u00eb juridike dhe harmonizimin me acquis t\u00eb Bashkimit Evropian, rekomandohet q\u00eb projektligji t\u00eb p\u00ebrfshij\u00eb afatet tranzitore t\u00eb p\u00ebrcaktuara nga <strong>Rregullorja (BE)<\/strong> 2023\/607, e cila ndryshoi Rregulloren (BE) 2017\/745 (MDR), si m\u00eb posht\u00eb:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>31 dhjetor 2027<\/strong>: p\u00ebrfundimi i periudh\u00ebs tranzitore p\u00ebr:\n<ul class=\"wp-block-list\">\n<li>pajisjet e klas\u00ebs III;<\/li>\n\n\n\n<li>pajisjet implantuese t\u00eb klas\u00ebs IIb, me p\u00ebrjashtim t\u00eb kategorive specifike t\u00eb pajisjeve p\u00ebr t\u00eb cilat MDR parashikon trajtim t\u00eb ve\u00e7ant\u00eb.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>31 dhjetor 2028<\/strong>: p\u00ebrfundimi i periudh\u00ebs tranzitore p\u00ebr:\n<ul class=\"wp-block-list\">\n<li>pajisjet e tjera t\u00eb klas\u00ebs IIb;<\/li>\n\n\n\n<li>pajisjet e klas\u00ebs IIa;<\/li>\n\n\n\n<li>pajisjet e klasave Is, Im dhe Ir;<\/li>\n\n\n\n<li>pajisjet q\u00eb sipas Direktiv\u00ebs 93\/42\/KEE nuk k\u00ebrkonin p\u00ebrfshirjen e nj\u00eb organizmi t\u00eb notifikuar, por q\u00eb sipas MDR-s\u00eb e k\u00ebrkojn\u00eb.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Gjithashtu rekomandohet q\u00eb ligji t\u00eb p\u00ebrcaktoj\u00eb <strong>kushtet sipas t\u00eb cilave k\u00ebto pajisje mund t\u00eb vazhdojn\u00eb t\u00eb vendosen n\u00eb treg gjat\u00eb periudh\u00ebs tranzitore,<\/strong> duke p\u00ebrfshir\u00eb:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>vlefshm\u00ebrin\u00eb e certifikatave ekzistuese;<\/li>\n\n\n\n<li>munges\u00ebn e ndryshimeve dometh\u00ebn\u00ebse n\u00eb projektim ose q\u00ebllimin e synuar;<\/li>\n\n\n\n<li>p\u00ebrmbushjen e k\u00ebrkesave p\u00ebr mbik\u00ebqyrjen pas tregtimit (PMS), vigjilenc\u00ebn, regjistrimin, gjurmueshm\u00ebrin\u00eb dhe mbik\u00ebqyrjen e tregut.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">P\u00ebrfshirja e k\u00ebtyre dispozitave do t\u00eb mund\u00ebsoj\u00eb <strong>nj\u00eb tranzicion t\u00eb rregullt drejt kuadrit t\u00eb ri rregullator,<\/strong> do t\u00eb minimizoj\u00eb rrezikun e mungesave n\u00eb furnizimin me pajisje mjek\u00ebsore dhe do t\u00eb siguroj\u00eb p\u00ebrputhshm\u00ebri me qasjen e Bashkimit Evropian.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Propozim p\u00ebr shtes\u00eb n\u00eb projektligj<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>\u201cPajisjet mjek\u00ebsore t\u00eb vendosura ligj\u00ebrisht n\u00eb treg sipas kuadrit t\u00eb m\u00ebparsh\u00ebm rregullator mund t\u00eb vazhdojn\u00eb t\u00eb vendosen n\u00eb treg ose t\u00eb vihen n\u00eb sh\u00ebrbim n\u00eb p\u00ebrputhje me periudhat tranzitore dhe kushtet e p\u00ebrcaktuara n\u00eb Rregulloren (BE) 2017\/745, t\u00eb ndryshuar me Rregulloren (BE) 2023\/607, respektivisht deri <strong>m\u00eb 26 maj 2026, 31 dhjetor 2027 ose 31 dhjetor 2028<\/strong>, n\u00eb var\u00ebsi t\u00eb klasifikimit t\u00eb pajisjes dhe procedur\u00ebs s\u00eb zbatueshme t\u00eb vler\u00ebsimit t\u00eb konformitetit.\u201d<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Referenca<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Rregullorja (BE) 2023\/607 q\u00eb ndryshon Rregulloret (BE) 2017\/745 dhe (BE) 2017\/746 lidhur me dispozitat tranzitore p\u00ebr pajisjet mjek\u00ebsore dhe pajisjet diagnostikuese in vitro. (<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2023\/607\/oj\/eng\">Link<\/a>)<\/li>\n\n\n\n<li>Dokumentet udh\u00ebzuese t\u00eb Komisionit Evropian mbi zbatimin e periudhave tranzitore MDR. (<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/48035948-beb1-47b3-8be2-8c500e59c24b_en?filename=md_20240926_imdrf2023_24th-session_day2_pres03.pdf\">Link<\/a>)<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6. Sistemi i Kund\u00ebrvajtjeve Administrative dhe Gjobave<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Megjith\u00ebse sistemi i kund\u00ebrvajtjeve administrative pasqyron n\u00eb p\u00ebrgjith\u00ebsi detyrimet e parashikuara nga Rregullorja (BE) 2017\/745 (MDR), vler\u00ebsojm\u00eb t\u00eb nevojsh\u00ebm <strong>nj\u00eb harmonizim m\u00eb t\u00eb plot\u00eb t\u00eb tij me parimet evropiane t\u00eb proporcionalitetit, siguris\u00eb juridike dhe mbik\u00ebqyrjes s\u00eb bazuar n\u00eb rrezik<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Aktualisht, projektligji <strong>grupon n\u00eb t\u00eb nj\u00ebjt\u00ebn kategori, kund\u00ebrvajtje me nivele shum\u00eb t\u00eb ndryshme t\u00eb ndikimit n\u00eb sh\u00ebndetin publik<\/strong> dhe parashikon masa nd\u00ebshkuese t\u00eb nj\u00ebjta p\u00ebr shkelje me rrezikshm\u00ebri t\u00eb ndryshme.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. Mungesa e diferencimit sipas nivelit t\u00eb rrezikut<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">N\u00eb t\u00eb nj\u00ebjt\u00ebn kategori sanksionesh p\u00ebrfshihen shkelje si:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>vendosja n\u00eb treg e nj\u00eb pajisjeje pa procedur\u00ebn e duhur t\u00eb vler\u00ebsimit t\u00eb konformitetit;<\/li>\n\n\n\n<li>vendosja n\u00eb treg e nj\u00eb pajisjeje t\u00eb klas\u00ebs III pa certifikimin p\u00ebrkat\u00ebs;<\/li>\n\n\n\n<li>mos-p\u00ebrdit\u00ebsimi i t\u00eb dh\u00ebnave t\u00eb regjistrimit;<\/li>\n\n\n\n<li>mang\u00ebsi administrative ose dokumentare.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">K\u00ebto shkelje <strong>nuk paraqesin t\u00eb nj\u00ebjtin nivel rreziku p\u00ebr pacient\u00ebt dhe sh\u00ebndetin publik.<\/strong> Rekomandohet q\u00eb sistemi i sanksioneve t\u00eb dalloj\u00eb nd\u00ebrmjet:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>shkeljeve kritike q\u00eb ndikojn\u00eb drejtp\u00ebrdrejt n\u00eb sigurin\u00eb e pacient\u00ebve;<\/li>\n\n\n\n<li>mosp\u00ebrputhjeve t\u00eb r\u00ebnda rregullatore;<\/li>\n\n\n\n<li>shkeljeve administrative dhe procedurale.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Nj\u00eb qasje e till\u00eb do t\u00eb siguronte proporcionalitet m\u00eb t\u00eb madh dhe zbatim m\u00eb efektiv.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. Mungesa e kritereve p\u00ebr p\u00ebrcaktimin e gjobave<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Projektligji parashikon gjoba fikse dhe gjoba t\u00eb bazuara n\u00eb xhiro, por <strong>nuk p\u00ebrcakton kriteret q\u00eb duhet t\u00eb merren n\u00eb konsiderat\u00eb p\u00ebr vler\u00ebsimin e secilit rast.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Mund t\u00eb konsiderohet p\u00ebrfshirja e faktor\u00ebve t\u00eb till\u00eb si:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>serioziteti i shkeljes;<\/li>\n\n\n\n<li>niveli i rrezikut p\u00ebr pacient\u00ebt dhe p\u00ebrdoruesit;<\/li>\n\n\n\n<li>karakteri i q\u00ebllimsh\u00ebm ose i pakujdessh\u00ebm i shkeljes;<\/li>\n\n\n\n<li>koh\u00ebzgjatja e mosp\u00ebrputhjes;<\/li>\n\n\n\n<li>historia e m\u00ebparshme e shkeljeve;<\/li>\n\n\n\n<li>shkalla e bashk\u00ebpunimit me autoritetin kompetent;<\/li>\n\n\n\n<li>masat korrigjuese t\u00eb nd\u00ebrmarra nga operatori ekonomik.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. Ndikimi potencial mbi operator\u00ebt e vegj\u00ebl dhe t\u00eb mes\u00ebm<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sistemi i propozuar parashikon:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>gjob\u00eb n\u00eb mas\u00ebn <strong>2% t\u00eb xhiros vjetore<\/strong> me prag minimal;<\/li>\n\n\n\n<li>gjob\u00eb fikse prej <strong>700.000 lek\u00ebsh;<\/strong><\/li>\n\n\n\n<li>gjob\u00eb fikse prej <strong>500.000 lek\u00ebsh.<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Nd\u00ebrsa sanksionet duhet t\u00eb jen\u00eb efektive dhe parandaluese, duhet t\u00eb merret parasysh edhe <strong>proporcionaliteti,<\/strong> ve\u00e7an\u00ebrisht p\u00ebr importuesit, shp\u00ebrndar\u00ebsit dhe p\u00ebrfaq\u00ebsuesit e autorizuar me aktivitet t\u00eb kufizuar ekonomik.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Rekomandim<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Rekomandohet q\u00eb <strong>Neni 85 t\u00eb korrigjohet dhe t\u00eb rinum\u00ebrohet si Neni 86<\/strong>, si dhe t&#8217;i n\u00ebnshtrohet <strong>nj\u00eb rishikimi t\u00eb plot\u00eb juridik<\/strong> dhe teknik p\u00ebrpara miratimit, me q\u00ebllim q\u00eb:<\/p>\n\n\n\n<ol start=\"1\" class=\"wp-block-list\">\n<li>T\u00eb vendoset <strong>nj\u00eb klasifikim m\u00eb i bazuar n\u00eb nivelin e rrezikut dhe m\u00eb proporcional i kund\u00ebrvajtjeve administrative.<\/strong><\/li>\n\n\n\n<li>T\u00eb p\u00ebrcaktohen <strong>kritere t\u00eb qarta<\/strong> <strong>p\u00ebr vendosjen e sanksioneve<\/strong>, bazuar n\u00eb seriozitetin e shkeljes, nivelin e rrezikut t\u00eb shkaktuar dhe rrethanat konkrete t\u00eb rastit.<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>7. <\/strong><strong>Nevoja p\u00ebr rishikim juridiko-teknik dhe sigurimin e koherenc\u00ebs s\u00eb brendshme t\u00eb projektligjit<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Projektligji k\u00ebrkon nj\u00eb <strong>rishikim t\u00eb plot\u00eb juridik dhe teknik, pasi disa dispozita p\u00ebrmbajn\u00eb referenca t\u00eb pasakta, mosp\u00ebrputhje n\u00eb num\u00ebrim dhe gabime redaktoriale,<\/strong> t\u00eb cilat mund t\u00eb cenojn\u00eb sigurin\u00eb juridike dhe zbatimin efektiv t\u00eb ligjit. M\u00eb posht\u00eb paraqiten disa shembuj:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. Referenc\u00eb e pasakt\u00eb ndaj Nenit 25, pika 2<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Neni 85(1.4)(a) parashikon:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><em>&#8220;nuk identifikon ndonj\u00eb nga personat ose institucionet e referuara n\u00eb nenin 25, pika 2, t\u00eb k\u00ebtij ligji&#8230;&#8221;<\/em><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Megjithat\u00eb, nga shqyrtimi i projektligjit rezulton se <strong>Neni 25 nuk p\u00ebrmban pik\u00ebn 2<\/strong>. P\u00ebr rrjedhoj\u00eb, detyrimi q\u00eb sanksionohet nuk mund t\u00eb identifikohet qart\u00eb.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>2. Referenca t\u00eb pasakta ndaj Nenit 75, pika 5, shkronja \u201ca\u201d<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Neni 85(1.4)(c) dhe Neni 85(1.4)(\u00e7) i referohen:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&#8220;&#8230;nenit 75, pika 5, shkronja &#8216;a&#8217;&#8230;&#8221;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Megjithat\u00eb, <strong>pika 5 e Nenit 75 nuk rezulton t\u00eb jet\u00eb e ndar\u00eb n\u00eb n\u00ebnparagraf\u00eb me shkronja.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>3. Referenc\u00eb e pasakt\u00eb ndaj Nenit 75, pika 5, shkronja \u201cb\u201d<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Neni 85(1.4)(d) i referohet:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&#8220;&#8230;nenit 75, pika 5, shkronja &#8216;b&#8217;&#8230;&#8221;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Por <strong>pika 5 e Nenit 75 nuk p\u00ebrmban shkronj\u00ebn \u201cb\u201d, duke e b\u00ebr\u00eb baz\u00ebn ligjore t\u00eb kund\u00ebrvajtjes t\u00eb paqart\u00eb.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>4. Num\u00ebrim i dyfisht\u00eb i Nenit 85<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Projektligji p\u00ebrmban <strong>dy dispozita me t\u00eb nj\u00ebjtin num\u00ebr:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Neni 85 \u2013 Njohja e pajisjeve me markim CE t\u00eb vendosura n\u00eb tregun e Bashkimit Evropian<\/strong><\/li>\n\n\n\n<li><strong>Neni 85 \u2013 Shkeljet dhe gjobat<\/strong><\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">P\u00ebr t\u00eb ruajtur koherenc\u00ebn e tekstit ligjor, dispozita \u201cShkeljet dhe gjobat\u201d duhet t\u00eb rinum\u00ebrohet si <strong>Neni 86<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>5. Mang\u00ebsi n\u00eb numerim dhe gabime redaktoriale<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">N\u00eb disa pika konstatohet munges\u00eb e identifikuesve t\u00eb shkronjave, p.sh.:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&#8220;) vendos n\u00eb treg nj\u00eb pajisje&#8230;&#8221;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Gjithashtu jan\u00eb identifikuar referenca me gabime evidente, si:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u201cpik\u00ebsn 2 t\u00eb Shtojc\u00ebs XIII\u201d;<\/li>\n\n\n\n<li>\u201cpik\u00ebsn 1 t\u00eb Pjes\u00ebs A t\u00eb Shtojc\u00ebs VI\u201d.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">K\u00ebto referenca duhet t\u00eb verifikohen dhe korrigjohen.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>6. Dispozita t\u00eb p\u00ebrs\u00ebritura<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">N\u00ebn pika 2.4, shkronjat <strong>d)<\/strong> dhe <strong>dh)<\/strong> <strong>p\u00ebrs\u00ebrisin t\u00eb nj\u00ebjtin detyrim t\u00eb shp\u00ebrndar\u00ebsit p\u00ebr njoftimin e prodhuesit dhe importuesit n\u00eb rast mosp\u00ebrputhjeje t\u00eb pajisjes.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">P\u00ebrs\u00ebritjet duhet t\u00eb eliminohen p\u00ebr t\u00eb shmangur paqart\u00ebsit\u00eb gjat\u00eb zbatimit.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Rekomandim<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Duke pasur parasysh numrin e konsideruesh\u00ebm t\u00eb gabimeve t\u00eb identifikuara, rekomandohet q\u00eb Ministria t\u00eb kryej\u00eb nj\u00eb <strong>rishikim t\u00eb plot\u00eb juridik, gjuh\u00ebsor dhe teknik t\u00eb projektligjit p\u00ebr:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>korrigjimin e t\u00eb gjitha referencave t\u00eb pasakta;<\/li>\n\n\n\n<li>verifikimin e ekzistenc\u00ebs s\u00eb t\u00eb gjitha neneve, pikave dhe n\u00ebnpikave t\u00eb referuara;<\/li>\n\n\n\n<li>korrigjimin e num\u00ebrimit t\u00eb neneve;<\/li>\n\n\n\n<li>eliminimin e dispozitave t\u00eb p\u00ebrs\u00ebritura;<\/li>\n\n\n\n<li>korrigjimin e gabimeve t\u00eb formatimit dhe transkriptimit;<\/li>\n\n\n\n<li>verifikimin e t\u00eb gjitha referencave ndaj shtojcave dhe dispozitave t\u00eb tjera t\u00eb ligjit;<\/li>\n\n\n\n<li>sigurimin q\u00eb \u00e7do kund\u00ebrvajtje administrative t\u00eb lidhet me nj\u00eb detyrim ligjor ekzistues dhe t\u00eb identifikuesh\u00ebm.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Meqen\u00ebse <strong>Neni 86 (i num\u00ebruar gabimisht si Neni 85)<\/strong> p\u00ebrmban dispozita sanksionuese, sakt\u00ebsia e referencave dhe cil\u00ebsia e hartimit jan\u00eb thelb\u00ebsore p\u00ebr t\u00eb garantuar sigurin\u00eb juridike, proporcionalitetin e zbatimit dhe vlefshm\u00ebrin\u00eb e masave administrative<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>III. PROJEKTLIGJI \u201cP\u00cbR PAJISJET MJEK\u00cbSORE DIAGNOSTIKUESE IN VITRO\u201d<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>1. Raporti me legjislacionin p\u00ebr p\u00ebrputhshm\u00ebrin\u00eb elektromagnetike dhe mbrojtjen nga rrezatimi jonizues<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">N\u00eb krahasim me struktur\u00ebn e <strong>Rregullores (BE) 2017\/746,<\/strong> konstatohet se dispozitat e publikuara t\u00eb projektligjit <strong>nuk pasqyrojn\u00eb shprehimisht dy klauzola q\u00eb rregullojn\u00eb raportin me legjislacione t\u00eb tjera horizontale.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">S\u00eb pari, mungon p\u00ebrcaktimi i raportit me <strong>legjislacionin p\u00ebr p\u00ebrputhshm\u00ebrin\u00eb elektromagnetike. <\/strong>S\u00eb dyti, nuk rezulton e pasqyruar klauzola q\u00eb garanton se legjislacioni p\u00ebr pajisjet diagnostikuese in vitro nuk c\u00ebnon zbatimin e <strong>legjislacionit t\u00eb posa\u00e7\u00ebm p\u00ebr mbrojtjen nga rreziqet e ekspozimit ndaj rrezatimit jonizues.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Kjo e fundit krijon edhe <strong>nj\u00eb \u00e7\u00ebshtje koherence nd\u00ebrmjet dy projektligjeve,<\/strong> pasi projektligji p\u00ebr pajisjet mjek\u00ebsore p\u00ebrmban shprehimisht nj\u00eb dispozit\u00eb t\u00eb till\u00eb.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Rekomandim<\/strong>: Sugjerojm\u00eb p\u00ebrfshirjen n\u00eb projektligjin p\u00ebr pajisjet mjek\u00ebsore diagnostikuese in vitro t\u00eb dispozitave q\u00eb p\u00ebrcaktojn\u00eb qart\u00eb:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>raportin me legjislacionin komb\u00ebtar p\u00ebr p\u00ebrputhshm\u00ebrin\u00eb elektromagnetike; dhe<\/li>\n\n\n\n<li>garantimin e zbatimit t\u00eb legjislacionit t\u00eb posa\u00e7\u00ebm p\u00ebr mbrojtjen nga rrezatimi jonizues.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Formulimet duhet t\u00eb p\u00ebrshtaten me rendin juridik shqiptar, duke ruajtur nj\u00ebkoh\u00ebsisht <strong>koherenc\u00ebn me Rregulloren (BE) 2017\/746 dhe me projektligjin paralel p\u00ebr pajisjet mjek\u00ebsore.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>N\u00eb p\u00ebrfundim<\/strong>, AmCham Albania mb\u00ebshtet objektivin e Ministris\u00eb p\u00ebr modernizimin dhe p\u00ebrafrimin e kuadrit shqiptar p\u00ebr pajisjet mjek\u00ebsore me acquis t\u00eb Bashkimit Evropian dhe vler\u00ebson r\u00ebnd\u00ebsin\u00eb e k\u00ebtij procesi p\u00ebr <strong>rritjen e siguris\u00eb s\u00eb pacient\u00ebve, parashikueshm\u00ebrin\u00eb rregullatore dhe mir\u00ebfunksionimin e tregut.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">N\u00eb k\u00ebt\u00eb kuad\u00ebr, k\u00ebrkojm\u00eb <strong>plot\u00ebsimin dhe publikimin e dokumentacionit shoq\u00ebrues t\u00eb projektligjeve<\/strong>, n\u00eb m\u00ebnyr\u00eb q\u00eb pal\u00ebt e interesuara t\u00eb ken\u00eb mund\u00ebsi t\u00eb kryejn\u00eb nj\u00eb shqyrtim t\u00eb plot\u00eb dhe t\u00eb mir\u00ebinformuar t\u00eb tyre. Gjithashtu, k\u00ebrkojm\u00eb q\u00eb <strong>komentet dhe rekomandimet e paraqitura nga an\u00ebtar\u00ebt tan\u00eb t\u00eb merren n\u00eb konsiderat\u00eb dhe t\u00eb vler\u00ebsohen n\u00eb kuad\u00ebr t\u00eb procesit t\u00eb konsultimit dhe finalizimit t\u00eb projektligjeve<\/strong>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">AmCham Albania dhe ekspert\u00ebt e kompanive tona an\u00ebtare mbeten t\u00eb gatsh\u00ebm p\u00ebr t\u00eb vijuar kontributin n\u00eb k\u00ebt\u00eb proces, p\u00ebrfshir\u00eb p\u00ebrmes <strong>diskutimeve teknike me strukturat dhe ekspert\u00ebt p\u00ebrgjegj\u00ebs t\u00eb Ministris\u00eb<\/strong>, me q\u00ebllim adresimin e \u00e7\u00ebshtjeve t\u00eb ngritura dhe p\u00ebrmir\u00ebsimin e m\u00ebtejsh\u00ebm t\u00eb kuadrit t\u00eb propozuar.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Duke shpresuar q\u00eb k\u00ebto komente dhe rekomandime do t\u00eb merren n\u00eb konsiderat\u00eb, mbetemi n\u00eb dispozicion p\u00ebr \u00e7do sqarim t\u00eb nevojsh\u00ebm.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Me respekt,<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dhoma Amerikane e Tregtis\u00eb<\/p>\n","protected":false},"excerpt":{"rendered":"<p>N\u00eb kuad\u00ebr t\u00eb procesit t\u00eb konsultimit publik p\u00ebr projektligjin \u201cP\u00ebr Pajisjet Mjek\u00ebsore\u201d dhe projektligjin \u201cP\u00ebr Pajisjet Mjek\u00ebsore Diagnostikuese In Vitro\u201d, t\u00eb publikuara m\u00eb 20 korrik 2026, Dhoma Amerikane e Tregtis\u00eb n\u00eb Shqip\u00ebri (AmCham Albania), pas konsultimit me an\u00ebtar\u00ebt e saj, paraqet n\u00eb vijim disa komente dhe rekomandime me synim p\u00ebrmir\u00ebsimin e qart\u00ebsis\u00eb, koherenc\u00ebs dhe zbatueshm\u00ebris\u00eb [&hellip;]<\/p>\n","protected":false},"author":15,"featured_media":116472,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","_seopress_robots_follow":"","_seopress_robots_imageindex":"","_seopress_robots_snippet":"","_seopress_robots_primary_cat":"","_seopress_robots_breadcrumbs":"","_seopress_robots_freeze_modified_date":"","_seopress_robots_custom_modified_date":"","_seopress_robots_canonical":"","_seopress_social_fb_title":"","_seopress_social_fb_desc":"","_seopress_social_fb_img":"","_seopress_social_fb_img_attachment_id":0,"_seopress_social_fb_img_width":0,"_seopress_social_fb_img_height":0,"_seopress_social_twitter_title":"","_seopress_social_twitter_desc":"","_seopress_social_twitter_img":"","_seopress_social_twitter_img_attachment_id":0,"_seopress_social_twitter_img_width":0,"_seopress_social_twitter_img_height":0,"_seopress_redirections_value":"","_seopress_redirections_enabled":"","_seopress_redirections_enabled_regex":"","_seopress_redirections_logged_status":"","_seopress_redirections_param":"","_seopress_redirections_type":0,"_seopress_analysis_target_kw":"","_seopress_news_disabled":"","_seopress_video_disabled":"","_seopress_video":[],"_seopress_pro_schemas_manual":[],"_seopress_pro_rich_snippets_disable_all":"","_seopress_pro_rich_snippets_disable":[],"_seopress_pro_schemas":[],"inline_featured_image":false,"footnotes":"","tve_updated_post":"","tve_custom_css":"","tve_user_custom_css":"","tve_globals":{},"tcb2_ready":0,"tcb_editor_enabled":0,"tve_landing_page":"","_tve_header":"","_tve_footer":""},"categories":[333,425,320,324],"tags":[],"class_list":["post-116474","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blogu","category-position-papers-sq","category-publikimet","category-slaidet","post-wrapper","thrv_wrapper"],"acf":[],"_links":{"self":[{"href":"https:\/\/amcham.com.al\/sq\/wp-json\/wp\/v2\/posts\/116474","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/amcham.com.al\/sq\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/amcham.com.al\/sq\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/amcham.com.al\/sq\/wp-json\/wp\/v2\/users\/15"}],"replies":[{"embeddable":true,"href":"https:\/\/amcham.com.al\/sq\/wp-json\/wp\/v2\/comments?post=116474"}],"version-history":[{"count":2,"href":"https:\/\/amcham.com.al\/sq\/wp-json\/wp\/v2\/posts\/116474\/revisions"}],"predecessor-version":[{"id":116476,"href":"https:\/\/amcham.com.al\/sq\/wp-json\/wp\/v2\/posts\/116474\/revisions\/116476"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/amcham.com.al\/sq\/wp-json\/wp\/v2\/media\/116472"}],"wp:attachment":[{"href":"https:\/\/amcham.com.al\/sq\/wp-json\/wp\/v2\/media?parent=116474"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/amcham.com.al\/sq\/wp-json\/wp\/v2\/categories?post=116474"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/amcham.com.al\/sq\/wp-json\/wp\/v2\/tags?post=116474"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}