{"id":18014,"date":"2026-09-14T11:39:47","date_gmt":"2026-09-14T08:39:47","guid":{"rendered":"https:\/\/www.kalitekit.com.tr\/?p=18014"},"modified":"2026-09-14T11:39:51","modified_gmt":"2026-09-14T08:39:51","slug":"prrc-nedir-kimler-prrc-olabilir","status":"publish","type":"post","link":"https:\/\/www.kalitekit.com.tr\/en\/prrc-nedir-kimler-prrc-olabilir\/","title":{"rendered":"PRRC Nedir? Kimler PRRC Olabilir? MDR Madde 15 \u015eartlar\u0131"},"content":{"rendered":"<style>\n.kk-prrc{max-width:960px;margin:0 auto;color:#202124;font-size:17px;line-height:1.78}\n.kk-prrc h1{font-size:36px;line-height:1.25;color:#111;margin:0 0 22px}\n.kk-prrc h2{font-size:27px;line-height:1.35;color:#111;margin:44px 0 17px}\n.kk-prrc h3{font-size:21px;line-height:1.4;color:#222;margin:29px 0 12px}\n.kk-prrc p{margin:0 0 18px}\n.kk-prrc ul,.kk-prrc ol{margin:0 0 22px 23px}\n.kk-prrc li{margin-bottom:8px}\n.kk-prrc a{text-decoration:underline}\n.kk-summary,.kk-info,.kk-warning,.kk-check{\npadding:20px 23px;margin:25px 0;border-radius:6px\n}\n.kk-summary{background:#fafafa;border:1px solid #ddd;border-left:5px solid #111}\n.kk-info{background:#f5f7f9;border-left:4px solid #333}\n.kk-warning{background:#fff7e6;border-left:4px solid #d18b00}\n.kk-check{background:#fafafa;border:1px solid #ddd}\n.kk-summary strong{font-size:19px}\n.kk-toc{background:#f7f7f7;border:1px solid #e1e1e1;padding:23px 26px;margin:30px 0;border-radius:7px}\n.kk-toc strong{display:block;font-size:20px;margin-bottom:12px}\n.kk-table{overflow-x:auto;margin:25px 0}\n.kk-prrc table{width:100%;border-collapse:collapse;min-width:680px}\n.kk-prrc th,.kk-prrc td{border:1px solid #d7d7d7;padding:12px 14px;text-align:left;vertical-align:top}\n.kk-prrc th{background:#f3f4f5;font-weight:700}\n.kk-flow{display:flex;flex-wrap:wrap;gap:7px;margin:25px 0}\n.kk-flow span{background:#f2f2f2;border:1px solid #ddd;padding:9px 12px;border-radius:4px;font-weight:600}\n.kk-faq{border-top:1px solid #e4e4e4;padding:20px 0}\n.kk-faq h3{margin-top:0}\n.kk-cta{background:#111;color:#fff;padding:29px;margin:40px 0;border-radius:7px}\n.kk-cta h2{color:#fff;margin-top:0}\n.kk-cta a{display:inline-block;background:#fff;color:#111;text-decoration:none;font-weight:700;padding:11px 17px;margin:5px 7px 5px 0;border-radius:4px}\n.kk-source{font-size:15px;color:#555}\n@media(max-width:768px){\n.kk-prrc{font-size:16px}\n.kk-prrc h1{font-size:29px}\n.kk-prrc h2{font-size:24px}\n}\n<\/style>\n\n<article class=\"kk-prrc\">\n\n\n<p>\n<strong>PRRC (Person Responsible for Regulatory Compliance)<\/strong>,\nMDR 2017\/745 ve IVDR 2017\/746 kapsam\u0131nda \u00fcreticinin veya yetkili temsilcinin\nmevzuata uyum s\u00fcre\u00e7lerinde belirli sorumluluklar\u0131 \u00fcstlenen\n<strong>Mevzuata Uyumdan Sorumlu Ki\u015fidir.<\/strong>\n<\/p>\n\n<p>\nAncak PRRC yaln\u0131zca organizasyon \u015femas\u0131nda ad\u0131 yaz\u0131lan veya k\u0131sa bir e\u011fitim\nsonras\u0131nda sertifika alan ki\u015fi de\u011fildir. MDR Madde 15, PRRC olabilecek ki\u015finin\nsahip olmas\u0131 gereken e\u011fitim ve mesleki deneyimi a\u00e7\u0131k \u015fekilde tan\u0131mlar.\n<\/p>\n\n<div class=\"kk-summary\">\n<strong>K\u0131sa cevap: Kimler PRRC olabilir?<\/strong>\n<p>\nMDR Madde 15&#8217;e g\u00f6re PRRC i\u00e7in iki temel yeterlilik yolu vard\u0131r.\n<\/p>\n<p>\n<strong>1. Yol:<\/strong> Hukuk, t\u0131p, eczac\u0131l\u0131k, m\u00fchendislik veya ba\u015fka bir ilgili\nbilimsel disiplinde uygun \u00fcniversite e\u011fitimi <strong>+ t\u0131bbi cihaz reg\u00fclasyonu veya\nkalite y\u00f6netim sistemlerinde en az 1 y\u0131l mesleki deneyim.<\/strong>\n<\/p>\n<p>\n<strong>2. Yol:<\/strong> Belirtilen akademik yeterlilik kullan\u0131lmadan,\nt\u0131bbi cihazlarla ilgili reg\u00fclasyon veya kalite y\u00f6netim sistemlerinde\n<strong>en az 4 y\u0131l mesleki deneyim.<\/strong>\n<\/p>\n<p>\nDolay\u0131s\u0131yla yaln\u0131zca PRRC e\u011fitimi almak veya PRRC sertifikas\u0131na sahip olmak,\ntek ba\u015f\u0131na Madde 15 yeterlili\u011fini sa\u011flamaz.\n<\/p>\n<\/div>\n\n<nav class=\"kk-toc\" aria-label=\"\u0130\u00e7indekiler\">\n<strong>\u0130\u00e7indekiler<\/strong>\n<ol>\n<li><a href=\"#prrc-nedir\">PRRC nedir?<\/a><\/li>\n<li><a href=\"#zorunlu\">PRRC zorunlu mu?<\/a><\/li>\n<li><a href=\"#kim-olabilir\">Kimler PRRC olabilir?<\/a><\/li>\n<li><a href=\"#bir-yil\">1 y\u0131ll\u0131k deneyim yolu<\/a><\/li>\n<li><a href=\"#dort-yil\">4 y\u0131ll\u0131k deneyim yolu<\/a><\/li>\n<li><a href=\"#deneyim\">Hangi deneyimler kabul edilir?<\/a><\/li>\n<li><a href=\"#biyoloji\">Biyoloji mezunu PRRC olabilir mi?<\/a><\/li>\n<li><a href=\"#sertifika\">PRRC sertifikas\u0131 zorunlu mu?<\/a><\/li>\n<li><a href=\"#kalite-muduru\">Kalite m\u00fcd\u00fcr\u00fc PRRC olabilir mi?<\/a><\/li>\n<li><a href=\"#disaridan\">D\u0131\u015far\u0131dan PRRC hizmeti al\u0131nabilir mi?<\/a><\/li>\n<li><a href=\"#mikro\">Mikro ve k\u00fc\u00e7\u00fck i\u015fletme nedir?<\/a><\/li>\n<li><a href=\"#gorevler\">PRRC&#8217;nin g\u00f6revleri nelerdir?<\/a><\/li>\n<li><a href=\"#teknik-dosya\">PRRC teknik dosyadan sorumlu mu?<\/a><\/li>\n<li><a href=\"#pms\">PMS ve vigilance sorumlulu\u011fu<\/a><\/li>\n<li><a href=\"#bagimsizlik\">PRRC&#8217;nin ba\u011f\u0131ms\u0131zl\u0131\u011f\u0131<\/a><\/li>\n<li><a href=\"#birden-fazla\">Birden fazla PRRC olabilir mi?<\/a><\/li>\n<li><a href=\"#ar\">Yetkili temsilcinin PRRC&#8217;si<\/a><\/li>\n<li><a href=\"#turkiye\">T\u00fcrkiye&#8217;deki \u00fcreticiler a\u00e7\u0131s\u0131ndan PRRC<\/a><\/li>\n<li><a href=\"#eudamed\">PRRC ve EUDAMED<\/a><\/li>\n<li><a href=\"#atama\">PRRC atamas\u0131 nas\u0131l dok\u00fcmante edilmeli?<\/a><\/li>\n<li><a href=\"#sss\">S\u0131k sorulan sorular<\/a><\/li>\n<\/ol>\n<\/nav>\n\n<h2 id=\"prrc-nedir\">PRRC Nedir?<\/h2>\n\n<p>\nPRRC, \u0130ngilizce <strong>Person Responsible for Regulatory Compliance<\/strong>\nifadesinin k\u0131saltmas\u0131d\u0131r.\n<\/p>\n\n<p>\nT\u00fcrk\u00e7ede genel olarak <strong>Mevzuata Uyumdan Sorumlu Ki\u015fi<\/strong>\n\u015feklinde ifade edilir.\n<\/p>\n\n<p>\nPRRC gereklili\u011fi MDR 2017\/745 Madde 15 ve IVDR 2017\/746 Madde 15\nkapsam\u0131nda d\u00fczenlenmi\u015ftir.\n<\/p>\n\n<p>\nPRRC&#8217;nin temel amac\u0131 \u00fcreticinin b\u00fct\u00fcn reg\u00fclasyon i\u015flerini tek ba\u015f\u0131na yapmak de\u011fildir.\nPRRC, mevzuatta kendisine verilen kritik alanlarda \u00fcreticinin y\u00fck\u00fcml\u00fcl\u00fcklerinin\nuygun \u015fekilde yerine getirildi\u011fini g\u00fcvence alt\u0131na alan d\u00fczenleyici fonksiyondur.\n<\/p>\n\n<div class=\"kk-info\">\n<strong>PRRC = b\u00fct\u00fcn reg\u00fclasyon i\u015flerini yapan ki\u015fi de\u011fildir.<\/strong>\n<p>\nTeknik dosyay\u0131 farkl\u0131 ki\u015filer haz\u0131rlayabilir, PMS faaliyetlerini ayr\u0131 bir ekip\ny\u00fcr\u00fctebilir ve \u00fcr\u00fcn serbest b\u0131rakma kontrollerini kalite birimi ger\u00e7ekle\u015ftirebilir.\nAncak PRRC, Madde 15&#8217;te kendisine verilen alanlarda gerekli s\u00fcre\u00e7lerin uygun\n\u015fekilde yerine getirildi\u011fini g\u00fcvence alt\u0131na almakla sorumludur.\n<\/p>\n<\/div>\n\n<h2 id=\"zorunlu\">PRRC Zorunlu mu?<\/h2>\n\n<p>\nEvet. MDR kapsam\u0131nda \u00fcreticilerin en az bir\n<strong>Mevzuata Uyumdan Sorumlu Ki\u015fiye<\/strong> sahip olmas\u0131 gerekir.\n<\/p>\n\n<p>\nAncak i\u015fletmenin b\u00fcy\u00fckl\u00fc\u011f\u00fc PRRC&#8217;nin organizasyonda nas\u0131l konumland\u0131r\u0131laca\u011f\u0131n\u0131 de\u011fi\u015ftirir.\n<\/p>\n\n<div class=\"kk-table\">\n<table>\n<thead>\n<tr>\n<th>Kurulu\u015f<\/th>\n<th>PRRC gereklili\u011fi<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Orta\/b\u00fcy\u00fck \u00fcretici<\/td>\n<td>En az bir PRRC kurulu\u015fun kendi organizasyonu i\u00e7erisinde bulunmal\u0131d\u0131r.<\/td>\n<\/tr>\n<tr>\n<td>Mikro \u00fcretici<\/td>\n<td>PRRC zorunludur ancak ki\u015finin organizasyonun \u00e7al\u0131\u015fan\u0131 olmas\u0131 \u015fart de\u011fildir; s\u00fcrekli ve devaml\u0131 \u015fekilde eri\u015filebilir olmal\u0131d\u0131r.<\/td>\n<\/tr>\n<tr>\n<td>K\u00fc\u00e7\u00fck \u00fcretici<\/td>\n<td>PRRC zorunludur ancak uygun \u015fartlarla d\u0131\u015far\u0131dan hizmet al\u0131nabilir.<\/td>\n<\/tr>\n<tr>\n<td>Yetkili temsilci<\/td>\n<td>En az bir nitelikli PRRC&#8217;yi s\u00fcrekli ve devaml\u0131 olarak eri\u015filebilir bulundurmal\u0131d\u0131r.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n<div class=\"kk-warning\">\n<strong>S\u0131k yap\u0131lan hata:<\/strong>\n\u201cMikro i\u015fletmeler PRRC atamak zorunda de\u011fil\u201d ifadesi yanl\u0131\u015ft\u0131r.\nMikro ve k\u00fc\u00e7\u00fck i\u015fletmeler yaln\u0131zca PRRC&#8217;yi kendi organizasyonlar\u0131n\u0131n i\u00e7erisinde\nbulundurma \u015fart\u0131ndan muaft\u0131r. PRRC gereklili\u011fi devam eder.\n<\/div>\n\n<h2 id=\"kim-olabilir\">Kimler PRRC Olabilir?<\/h2>\n\n<p>\nMDR Madde 15(1), gerekli uzmanl\u0131\u011f\u0131n iki alternatif yoldan biriyle\nkan\u0131tlanabilece\u011fini belirtir.\n<\/p>\n\n<div class=\"kk-table\">\n<table>\n<thead>\n<tr>\n<th>Yol<\/th>\n<th>Akademik yeterlilik<\/th>\n<th>Mesleki deneyim<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>Yol A<\/strong><\/td>\n<td>Hukuk, t\u0131p, eczac\u0131l\u0131k, m\u00fchendislik veya ba\u015fka bir ilgili bilimsel disiplinde \u00fcniversite derecesi ya da kabul edilen e\u015fde\u011fer formal yeterlilik<\/td>\n<td><strong>En az 1 y\u0131l<\/strong> t\u0131bbi cihaz reg\u00fclasyonu veya t\u0131bbi cihazlarla ilgili kalite y\u00f6netim sistemi deneyimi<\/td>\n<\/tr>\n<tr>\n<td><strong>Yol B<\/strong><\/td>\n<td>Belirtilen akademik yeterlilik aranmaz<\/td>\n<td><strong>En az 4 y\u0131l<\/strong> t\u0131bbi cihaz reg\u00fclasyonu veya t\u0131bbi cihazlarla ilgili kalite y\u00f6netim sistemi deneyimi<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n<p>\nDolay\u0131s\u0131yla PRRC olmak i\u00e7in yaln\u0131zca \u00fcniversite diplomas\u0131na sahip olmak\nyeterli olmad\u0131\u011f\u0131 gibi yaln\u0131zca t\u0131bbi cihaz sekt\u00f6r\u00fcnde \u00e7al\u0131\u015fm\u0131\u015f olmak da\nher durumda yeterli de\u011fildir.\n<\/p>\n\n<h2 id=\"bir-yil\">PRRC \u0130\u00e7in 1 Y\u0131ll\u0131k Deneyim \u015eart\u0131<\/h2>\n\n<p>\nKi\u015fi uygun bir akademik yeterlili\u011fe sahipse PRRC olabilmek i\u00e7in ayr\u0131ca\n<strong>en az bir y\u0131l profesyonel deneyime<\/strong> sahip olmal\u0131d\u0131r.\n<\/p>\n\n<p>\nBu deneyimin;\n<\/p>\n\n<ul>\n<li>t\u0131bbi cihaz reg\u00fclasyonu veya<\/li>\n<li>t\u0131bbi cihazlara ili\u015fkin kalite y\u00f6netim sistemleri<\/li>\n<\/ul>\n\n<p>\nalan\u0131nda olmas\u0131 gerekir.\n<\/p>\n\n<p>\nMDCG 2019-7 Rev.1 bu deneyimin ayr\u0131ca\n<strong>AB t\u0131bbi cihaz mevzuat\u0131 gereklilikleriyle ili\u015fkili, somut ve g\u00fcncel<\/strong>\nolmas\u0131n\u0131 beklemektedir.\n<\/p>\n\n<div class=\"kk-info\">\n<strong>\u00d6rnek:<\/strong>\n<p>\nBiyomedikal m\u00fchendisli\u011fi mezunu bir ki\u015finin yaln\u0131zca hastanede teknik servis\nm\u00fchendisi olarak bir y\u0131l \u00e7al\u0131\u015fm\u0131\u015f olmas\u0131, yapt\u0131\u011f\u0131 i\u015f reg\u00fclasyon veya t\u0131bbi cihaz\nKYS faaliyetleriyle ili\u015fkili de\u011filse Madde 15&#8217;teki deneyim \u015fart\u0131n\u0131 otomatik olarak\nkan\u0131tlamaz.\n<\/p>\n<\/div>\n\n<h2 id=\"dort-yil\">\u00dcniversite Diplomas\u0131 Olmadan PRRC Olunabilir mi?<\/h2>\n\n<p>\nMDR&#8217;nin ikinci yeterlilik yolu bunun i\u00e7in \u00f6nemlidir.\n<\/p>\n\n<p>\nKi\u015finin t\u0131bbi cihazlara ili\u015fkin;\n<\/p>\n\n<ul>\n<li>regulatory affairs veya<\/li>\n<li>quality management systems<\/li>\n<\/ul>\n\n<p>\nalan\u0131nda <strong>en az d\u00f6rt y\u0131ll\u0131k profesyonel deneyimi<\/strong> bulunuyorsa\nMadde 15(1)(b) yoluyla gerekli uzmanl\u0131k kan\u0131tlanabilir.\n<\/p>\n\n<p>\nBu yolda Madde 15(1)(a)&#8217;da belirtilen \u00fcniversite diplomas\u0131 \u015fart\u0131 aranmaz.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>Ancak \u201c4 y\u0131l herhangi bir t\u0131bbi cihaz deneyimi\u201d yeterli de\u011fildir.<\/strong>\n<p>\nDeneyimin reg\u00fclasyon veya t\u0131bbi cihaz kalite y\u00f6netim sistemi alan\u0131nda olmas\u0131 gerekir.\n\u00dcretimde d\u00f6rt y\u0131l operat\u00f6r olarak \u00e7al\u0131\u015fmak, sat\u0131\u015f yapmak veya yaln\u0131zca idari belge\ni\u015flemek tek ba\u015f\u0131na ayn\u0131 anlama gelmez.\n<\/p>\n<\/div>\n\n<h2 id=\"deneyim\">PRRC Deneyimi Nas\u0131l Kan\u0131tlan\u0131r?<\/h2>\n\n<p>\nMDCG 2019-7 Rev.1, PRRC&#8217;yi atayan \u00fcreticinin ki\u015finin gerekli yeterlili\u011fe sahip\noldu\u011funu kan\u0131tlayacak yeterli dok\u00fcman\u0131 toplamas\u0131n\u0131 beklemektedir.\n<\/p>\n\n<p>Kan\u0131tlar aras\u0131nda \u00f6rne\u011fin;<\/p>\n\n<ul>\n<li>\u00f6zge\u00e7mi\u015f,<\/li>\n<li>diploma,<\/li>\n<li>\u00e7al\u0131\u015fma belgeleri,<\/li>\n<li>i\u015f s\u00f6zle\u015fmeleri,<\/li>\n<li>g\u00f6rev tan\u0131mlar\u0131,<\/li>\n<li>i\u015fveren yaz\u0131lar\u0131,<\/li>\n<li>organizasyon \u015femalar\u0131,<\/li>\n<li>haz\u0131rlanan veya onaylanan KYS kay\u0131tlar\u0131,<\/li>\n<li>teknik dok\u00fcmantasyon \u00e7al\u0131\u015fmalar\u0131,<\/li>\n<li>reg\u00fclasyon faaliyetlerine ili\u015fkin kay\u0131tlar,<\/li>\n<li>e\u011fitim ve yetkinlik kay\u0131tlar\u0131<\/li>\n<\/ul>\n\n<p>\nkullan\u0131labilir.\n<\/p>\n\n<p>\nBurada yaln\u0131zca \u00e7al\u0131\u015fma s\u00fcresini de\u011fil,\n<strong>ki\u015finin bu s\u00fcre i\u00e7inde ger\u00e7ekte hangi i\u015fi yapt\u0131\u011f\u0131n\u0131<\/strong>\ng\u00f6sterebilmek \u00f6nemlidir.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>MDCG \u00f6nemli bir s\u0131n\u0131r \u00e7iziyor:<\/strong>\n<p>\nYaln\u0131zca dok\u00fcmanlar\u0131n idari olarak i\u015flenmesi veya regulatory affairs\nuzmanlar\u0131n\u0131 g\u00f6zlemlemek gibi faaliyetler yeterli mesleki deneyim olarak\nkabul edilmemelidir.\n<\/p>\n<\/div>\n\n<h2 id=\"biyoloji\">Biyoloji Mezunu PRRC Olabilir mi?<\/h2>\n\n<p>\nBu, PRRC konusunda en s\u0131k sorulan sorulardan biridir.\n<\/p>\n\n<p>\nMDR Madde 15 yaln\u0131zca hukuk, t\u0131p, eczac\u0131l\u0131k ve m\u00fchendislik b\u00f6l\u00fcmlerini saymaz.\nBunlara ek olarak <strong>\u201canother relevant scientific discipline\u201d yani\n\u201cba\u015fka bir ilgili bilimsel disiplin\u201d<\/strong> ifadesini de kullan\u0131r.\n<\/p>\n\n<p>\nDolay\u0131s\u0131yla biyoloji, kimya veya benzeri bilimsel bir b\u00f6l\u00fcm\u00fcn\nPRRC akademik yeterlili\u011fi a\u00e7\u0131s\u0131ndan de\u011ferlendirilmesi m\u00fcmk\u00fcnd\u00fcr.\n<\/p>\n\n<p>\nAncak burada iki \u00f6nemli nokta vard\u0131r:\n<\/p>\n\n<ol>\n<li>Mezun olunan disiplinin yap\u0131lan t\u0131bbi cihaz faaliyetleri bak\u0131m\u0131ndan <strong>ilgili<\/strong> oldu\u011funun gerek\u00e7elendirilebilmesi,<\/li>\n<li>Madde 15(1)(a) yolu kullan\u0131l\u0131yorsa ayr\u0131ca en az <strong>1 y\u0131l uygun mesleki deneyimin<\/strong> kan\u0131tlanabilmesi.<\/li>\n<\/ol>\n\n<div class=\"kk-warning\">\n<strong>Biyoloji diplomas\u0131 tek ba\u015f\u0131na \u201cotomatik PRRC yeterlili\u011fi\u201d anlam\u0131na gelmez.<\/strong>\n<p>\nPRRC atayan \u00fcreticinin hem formal yeterlili\u011fi hem de gerekli t\u0131bbi cihaz\nreg\u00fclasyon\/KYS deneyimini dok\u00fcmante ederek ki\u015finin ilgili g\u00f6revi yerine\ngetirebilecek uzmanl\u0131\u011fa sahip oldu\u011funu g\u00f6sterebilmesi gerekir.\n<\/p>\n<\/div>\n\n<h3>T\u00fcrkiye&#8217;den al\u0131nan diploma a\u00e7\u0131s\u0131ndan \u00f6nemli ayr\u0131nt\u0131<\/h3>\n\n<p>\nMDCG 2019-7 Rev.1, AB d\u0131\u015f\u0131nda edinilmi\u015f diploma veya di\u011fer formal yeterliliklerin\nMadde 15(1)(a) yolu i\u00e7in kullan\u0131lmas\u0131 halinde, ilgili yeterlili\u011fin\n<strong>bir AB \u00dcye Devleti taraf\u0131ndan kar\u015f\u0131l\u0131k gelen ulusal yeterlili\u011fe e\u015fde\u011fer\nolarak tan\u0131nm\u0131\u015f olmas\u0131n\u0131n yeterli oldu\u011funu<\/strong> belirtmektedir.\n<\/p>\n\n<p>\nBu husus \u00f6zellikle T\u00fcrkiye&#8217;deki bir \u00fcniversiteden mezun olup\nAB MDR kapsam\u0131nda bir \u00fcreticinin PRRC&#8217;si olarak atanacak ki\u015filer a\u00e7\u0131s\u0131ndan\ng\u00f6zden ka\u00e7\u0131r\u0131lmamal\u0131d\u0131r.\n<\/p>\n\n<h2 id=\"sertifika\">PRRC Sertifikas\u0131 Zorunlu mu?<\/h2>\n\n<p>\nMDR Madde 15&#8217;te ayr\u0131ca tan\u0131mlanm\u0131\u015f zorunlu bir\n<strong>\u201cPRRC e\u011fitim sertifikas\u0131\u201d<\/strong> \u015fart\u0131 bulunmamaktad\u0131r.\n<\/p>\n\n<p>\nPRRC yeterlili\u011fi;\n<\/p>\n\n<p>\n<strong>uygun formal yeterlilik + 1 y\u0131l ilgili deneyim<\/strong>\n<\/p>\n\n<p>veya<\/p>\n\n<p>\n<strong>4 y\u0131l ilgili profesyonel deneyim<\/strong>\n<\/p>\n\n<p>\nyollar\u0131ndan biri \u00fczerinden de\u011ferlendirilir.\n<\/p>\n\n<p>\nPRRC e\u011fitimi al\u0131nmas\u0131 ki\u015finin MDR\/IVDR bilgilerini geli\u015ftirmek ve\nyetkinlik kay\u0131tlar\u0131n\u0131 desteklemek a\u00e7\u0131s\u0131ndan yararl\u0131 olabilir.\nAncak birka\u00e7 g\u00fcnl\u00fck PRRC e\u011fitiminden al\u0131nan kat\u0131l\u0131m veya ba\u015far\u0131 sertifikas\u0131\nMadde 15&#8217;teki deneyimin yerine ge\u00e7mez.\n<\/p>\n\n<div class=\"kk-info\">\n<strong>K\u0131sacas\u0131:<\/strong><br>\nPRRC e\u011fitimi \u2260 PRRC yeterlili\u011fi.<br>\nE\u011fitim destekleyicidir; Madde 15 \u015fartlar\u0131n\u0131 ortadan kald\u0131rmaz.\n<\/div>\n\n<h2 id=\"kalite-muduru\">Kalite M\u00fcd\u00fcr\u00fc PRRC Olabilir mi?<\/h2>\n\n<p>\nEvet, gerekli yeterlilikleri sa\u011flamas\u0131 halinde bir kalite m\u00fcd\u00fcr\u00fc\nayn\u0131 zamanda PRRC olarak atanabilir.\n<\/p>\n\n<p>\nAncak ki\u015finin i\u015f unvan\u0131n\u0131n \u201cKalite M\u00fcd\u00fcr\u00fc\u201d, \u201cKalite Y\u00f6neticisi\u201d,\n\u201cRegulatory Affairs Manager\u201d veya benzeri olmas\u0131 kendi ba\u015f\u0131na\nPRRC yeterlili\u011finin kan\u0131t\u0131 de\u011fildir.\n<\/p>\n\n<p>\nKi\u015finin;\n<\/p>\n\n<ul>\n<li>Madde 15 yeterlilik \u015fartlar\u0131n\u0131 kar\u015f\u0131lamas\u0131,<\/li>\n<li>PRRC sorumluluklar\u0131n\u0131n g\u00f6rev tan\u0131m\u0131nda a\u00e7\u0131k\u00e7a belirlenmesi,<\/li>\n<li>gerekli bilgi ve kay\u0131tlara eri\u015febilmesi,<\/li>\n<li>g\u00f6revlerini yerine getirebilecek yetkiye sahip olmas\u0131<\/li>\n<\/ul>\n\n<p>\ngerekir.\n<\/p>\n\n<h3>PRRC ile Kalite M\u00fcd\u00fcr\u00fc aras\u0131ndaki fark nedir?<\/h3>\n\n<div class=\"kk-table\">\n<table>\n<thead>\n<tr>\n<th>Kalite M\u00fcd\u00fcr\u00fc<\/th>\n<th>PRRC<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Kurulu\u015fun KYS yap\u0131s\u0131 i\u00e7indeki organizasyonel bir g\u00f6revdir.<\/td>\n<td>MDR\/IVDR Madde 15 taraf\u0131ndan d\u00fczenlenen mevzuata dayal\u0131 bir fonksiyondur.<\/td>\n<\/tr>\n<tr>\n<td>G\u00f6rev kapsam\u0131 \u015firket taraf\u0131ndan belirlenebilir.<\/td>\n<td>En az\u0131ndan Madde 15(3)&#8217;teki sorumluluklar\u0131 kapsamal\u0131d\u0131r.<\/td>\n<\/tr>\n<tr>\n<td>PRRC olmas\u0131 otomatik de\u011fildir.<\/td>\n<td>Madde 15 yeterlilik kriterlerini kar\u015f\u0131lamal\u0131d\u0131r.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n<h2 id=\"disaridan\">D\u0131\u015far\u0131dan PRRC Hizmeti Al\u0131nabilir mi?<\/h2>\n\n<p>\n<strong>Evet, ancak her \u00fcretici i\u00e7in de\u011fil.<\/strong>\n<\/p>\n\n<p>\nMDR Madde 15(2), mikro ve k\u00fc\u00e7\u00fck i\u015fletmelerin PRRC&#8217;yi kendi\norganizasyonlar\u0131n\u0131n i\u00e7erisinde bulundurma zorunlulu\u011funu kald\u0131r\u0131r.\n<\/p>\n\n<p>\nBu i\u015fletmeler nitelikli bir PRRC&#8217;yi\n<strong>s\u00fcrekli ve devaml\u0131 \u015fekilde eri\u015filebilir<\/strong>\nbulundurmak \u015fart\u0131yla d\u0131\u015far\u0131dan hizmet alabilir.\n<\/p>\n\n<p>\nMDCG 2019-7 Rev.1 bu durumda \u00fcretici ile d\u0131\u015f PRRC veya PRRC&#8217;nin ba\u011fl\u0131 oldu\u011fu\nkurulu\u015f aras\u0131nda bir s\u00f6zle\u015fme kurulabilece\u011fini belirtir.\n<\/p>\n\n<h3>D\u0131\u015f PRRC s\u00f6zle\u015fmesinde neler bulunmal\u0131?<\/h3>\n\n<p>S\u00f6zle\u015fmede en az\u0131ndan;<\/p>\n\n<ul>\n<li>PRRC olarak g\u00f6revlendirilen ki\u015finin kimli\u011fi,<\/li>\n<li>Madde 15 yeterlilik dayana\u011f\u0131,<\/li>\n<li>g\u00f6rev ve sorumluluklar,<\/li>\n<li>hangi \u00fcr\u00fcn\/\u00fcr\u00fcn gruplar\u0131n\u0131 kapsad\u0131\u011f\u0131,<\/li>\n<li>bilgi ve dok\u00fcmana eri\u015fim,<\/li>\n<li>ileti\u015fim y\u00f6ntemi,<\/li>\n<li>acil vigilance durumlar\u0131nda ula\u015f\u0131labilirlik,<\/li>\n<li>s\u00fcreklilik d\u00fczenlemesi,<\/li>\n<li>de\u011fi\u015fiklik ve fesih durumundaki devir s\u00fcreci<\/li>\n<\/ul>\n\n<p>\ngibi konular\u0131n a\u00e7\u0131k\u00e7a tan\u0131mlanmas\u0131 yararl\u0131 olacakt\u0131r.\n<\/p>\n\n<div class=\"kk-info\">\n<strong>\u201cS\u00fcrekli ve devaml\u0131 eri\u015filebilir\u201d = 7\/24 telefonda beklemek de\u011fildir.<\/strong>\n<p>\nMDCG 2019-7 Rev.1, PRRC&#8217;nin g\u00f6revlerini ger\u00e7ekle\u015ftirebilecek ve gerekti\u011finde\nzaman\u0131nda reaksiyon g\u00f6sterebilecek \u015fekilde eri\u015filebilir olmas\u0131n\u0131 esas al\u0131r.\nBu ifade g\u00fcnl\u00fck 24 saat eri\u015filebilirlik anlam\u0131na gelmez.\n<\/p>\n<\/div>\n\n<h2 id=\"mikro\">MDR&#8217;ye G\u00f6re Mikro ve K\u00fc\u00e7\u00fck \u0130\u015fletme Nedir?<\/h2>\n\n<p>\nMDR, mikro ve k\u00fc\u00e7\u00fck i\u015fletme de\u011ferlendirmesinde\n<strong>Komisyon Tavsiye Karar\u0131 2003\/361\/EC<\/strong> tan\u0131m\u0131na at\u0131f yapar.\n<\/p>\n\n<div class=\"kk-table\">\n<table>\n<thead>\n<tr>\n<th>Business<\/th>\n<th>\u00c7al\u0131\u015fan say\u0131s\u0131<\/th>\n<th>Y\u0131ll\u0131k ciro veya bilan\u00e7o toplam\u0131<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>Mikro i\u015fletme<\/strong><\/td>\n<td>10&#8217;dan az<\/td>\n<td>2 milyon \u20ac&#8217;yu a\u015fmayan<\/td>\n<\/tr>\n<tr>\n<td><strong>K\u00fc\u00e7\u00fck i\u015fletme<\/strong><\/td>\n<td>50&#8217;den az<\/td>\n<td>10 milyon \u20ac&#8217;yu a\u015fmayan<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n<p>\n\u0130\u015fletmenin ba\u011fl\u0131 veya ortak i\u015fletmelerle ili\u015fkileri de KOB\u0130 stat\u00fcs\u00fc\nhesaplamas\u0131nda etkili olabilece\u011finden yaln\u0131zca \u015firketin kendi bordro say\u0131s\u0131na\nbakarak kesin sonuca var\u0131lmamal\u0131d\u0131r.\n<\/p>\n\n<h2 id=\"gorevler\">PRRC&#8217;nin G\u00f6revleri Nelerdir?<\/h2>\n\n<p>\nMDR Madde 15(3), PRRC&#8217;nin en az\u0131ndan g\u00fcvence alt\u0131na almas\u0131 gereken\nbe\u015f temel alan\u0131 tan\u0131mlar.\n<\/p>\n\n<div class=\"kk-table\">\n<table>\n<thead>\n<tr>\n<th>Alan<\/th>\n<th>PRRC&#8217;nin temel sorumlulu\u011fu<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td><strong>1. \u00dcr\u00fcn uygunlu\u011fu<\/strong><\/td>\n<td>Cihaz piyasaya verilmeden \u00f6nce uygunlu\u011fun ilgili KYS kapsam\u0131nda uygun \u015fekilde kontrol edildi\u011fini g\u00fcvence alt\u0131na almak.<\/td>\n<\/tr>\n<tr>\n<td><strong>2. Teknik dok\u00fcmantasyon<\/strong><\/td>\n<td>Teknik dok\u00fcmantasyon ve AB Uygunluk Beyan\u0131n\u0131n haz\u0131rlanmas\u0131n\u0131 ve g\u00fcncel tutulmas\u0131n\u0131 g\u00fcvence alt\u0131na almak.<\/td>\n<\/tr>\n<tr>\n<td><strong>3. PMS<\/strong><\/td>\n<td>Piyasa sonras\u0131 g\u00f6zetim y\u00fck\u00fcml\u00fcl\u00fcklerinin yerine getirilmesini g\u00fcvence alt\u0131na almak.<\/td>\n<\/tr>\n<tr>\n<td><strong>4. Vigilance<\/strong><\/td>\n<td>MDR Madde 87-91 kapsam\u0131ndaki raporlama y\u00fck\u00fcml\u00fcl\u00fcklerinin yerine getirilmesini g\u00fcvence alt\u0131na almak.<\/td>\n<\/tr>\n<tr>\n<td><strong>5. Ara\u015ft\u0131rma cihazlar\u0131<\/strong><\/td>\n<td>Ara\u015ft\u0131rma ama\u00e7l\u0131 cihazlarda Annex XV kapsam\u0131nda gerekli beyan\u0131n d\u00fczenlenmesini g\u00fcvence alt\u0131na almak.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n\n<p>\nBuradaki <strong>\u201censuring\u201d<\/strong> yakla\u015f\u0131m\u0131 \u00f6nemlidir.\nPRRC&#8217;nin b\u00fct\u00fcn dok\u00fcmanlar\u0131 \u015fahsen yazmas\u0131 gerekmez.\nAncak gerekli s\u00fcrecin mevzuata uygun \u015fekilde ger\u00e7ekle\u015fti\u011fini g\u00fcvence alt\u0131na\nalabilecek yetki, bilgi ve eri\u015fime sahip olmas\u0131 gerekir.\n<\/p>\n\n<h2 id=\"teknik-dosya\">PRRC Teknik Dosyadan Sorumlu mu?<\/h2>\n\n<p>\nPRRC, MDR Madde 15 kapsam\u0131nda teknik dok\u00fcmantasyonun ve\nAB Uygunluk Beyan\u0131n\u0131n haz\u0131rlanmas\u0131n\u0131 ve g\u00fcncelli\u011fini g\u00fcvence alt\u0131na almakla\nsorumludur.\n<\/p>\n\n<p>\nBu, teknik dosyan\u0131n tamam\u0131n\u0131 PRRC&#8217;nin tek ba\u015f\u0131na haz\u0131rlamas\u0131 gerekti\u011fi anlam\u0131na gelmez.\n<\/p>\n\n<p>\nTeknik dok\u00fcmantasyon;\n<\/p>\n\n<ul>\n<li>Ar-Ge,<\/li>\n<li>kalite,<\/li>\n<li>reg\u00fclasyon,<\/li>\n<li>klinik,<\/li>\n<li>\u00fcretim,<\/li>\n<li>yaz\u0131l\u0131m ve<\/li>\n<li>d\u0131\u015f uzmanlar<\/li>\n<\/ul>\n\n<p>\ntaraf\u0131ndan haz\u0131rlanan \u00e7ok say\u0131da kan\u0131t\u0131 i\u00e7erebilir.\n<\/p>\n\n<p>\nPRRC a\u00e7\u0131s\u0131ndan \u00f6nemli olan; dok\u00fcmantasyonun varl\u0131\u011f\u0131, g\u00fcncelli\u011fi,\ntutarl\u0131l\u0131\u011f\u0131 ve uygulanabilir mevzuat gerekliliklerini kar\u015f\u0131layan\nsistem i\u00e7erisinde y\u00f6netildi\u011finin g\u00fcvence alt\u0131na al\u0131nmas\u0131d\u0131r.\n<\/p>\n\n<p>\nTeknik dosya yap\u0131s\u0131n\u0131 incelemek i\u00e7in\n<a href=\"\/en\/mdr-uyumlu-teknik-dosya-technical-documentation-hazirlama-rehberi\/\">\n<strong>MDR Uyumlu Teknik Dosya Haz\u0131rlama Rehberimizi<\/strong>\n<\/a>\ninceleyebilirsiniz.\n<\/p>\n\n<h2 id=\"pms\">PRRC&#8217;nin PMS ve Vigilance Sorumlulu\u011fu<\/h2>\n\n<p>\nPRRC&#8217;nin g\u00f6revi CE i\u015faretinin al\u0131nmas\u0131yla bitmez.\nMadde 15, PRRC&#8217;yi do\u011frudan piyasa sonras\u0131 faaliyetlerle de ili\u015fkilendirir.\n<\/p>\n\n<p>\nPRRC;\n<\/p>\n\n<ul>\n<li>PMS y\u00fck\u00fcml\u00fcl\u00fcklerinin yerine getirildi\u011fini,<\/li>\n<li>gerekli raporlamalar\u0131n yap\u0131ld\u0131\u011f\u0131n\u0131,<\/li>\n<li>vigilance s\u00fcrecinin mevzuata uygun y\u00fcr\u00fct\u00fcld\u00fc\u011f\u00fcn\u00fc<\/li>\n<\/ul>\n\n<p>\ng\u00fcvence alt\u0131na alan sistemin i\u00e7erisinde yer almal\u0131d\u0131r.\n<\/p>\n\n<p>\nPMS konusunda\n<a href=\"\/en\/post-market-surveillance-pms-ve-vigilance-sureci-mdr-uyumunda-kritik-adimlar\/\">\n<strong>Post-Market Surveillance ve Vigilance Rehberini<\/strong>\n<\/a>,\nPMCF taraf\u0131nda ise\n<a href=\"\/en\/mdr-post-market-clinical-follow-up-pmcf-plani-ve-raporu-hazirlama-rehberi\/\">\n<strong>PMCF Plan\u0131 ve Raporu Haz\u0131rlama Rehberini<\/strong>\n<\/a>\ninceleyebilirsiniz.\n<\/p>\n\n<h2 id=\"bagimsizlik\">PRRC Y\u00f6netimden Ba\u011f\u0131ms\u0131z m\u0131 Olmal\u0131?<\/h2>\n\n<p>\nPRRC&#8217;nin organizasyonda hi\u00e7bir y\u00f6neticiye ba\u011fl\u0131 olmamas\u0131 \u015feklinde ayr\u0131 bir\norganizasyon modeli MDR&#8217;de tan\u0131mlanmam\u0131\u015ft\u0131r.\n<\/p>\n\n<p>\nAncak Madde 15(5) \u00e7ok \u00f6nemli bir koruma getirir:\nPRRC, g\u00f6revlerini uygun \u015fekilde yerine getirmesi nedeniyle kurulu\u015f i\u00e7erisinde\n<strong>herhangi bir dezavantaja maruz b\u0131rak\u0131lmamal\u0131d\u0131r.<\/strong>\n<\/p>\n\n<p>\n\u00d6rne\u011fin PRRC;\n<\/p>\n\n<ul>\n<li>uygunsuz bir \u00fcr\u00fcn\u00fcn serbest b\u0131rak\u0131lmas\u0131na itiraz etti\u011fi,<\/li>\n<li>teknik dosyadaki eksikli\u011fi bildirdi\u011fi,<\/li>\n<li>vigilance bildiriminin yap\u0131lmas\u0131 gerekti\u011fini belirtti\u011fi veya<\/li>\n<li>mevzuata ayk\u0131r\u0131 bir i\u015flemi durdurdu\u011fu<\/li>\n<\/ul>\n\n<p>\ni\u00e7in cezaland\u0131r\u0131lmamal\u0131 veya g\u00f6revini do\u011fru yapt\u0131\u011f\u0131 i\u00e7in profesyonel\ndezavantaja u\u011frat\u0131lmamal\u0131d\u0131r.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>PRRC yaln\u0131zca imza atan ki\u015fi olmamal\u0131d\u0131r.<\/strong>\n<p>\nKi\u015fiye PRRC sorumlulu\u011fu verilip teknik dosyaya, PMS kay\u0131tlar\u0131na,\nuygunsuzluklara veya \u00fcr\u00fcn serbest b\u0131rakma bilgilerine eri\u015fim verilmemesi,\nPRRC fonksiyonunun ger\u00e7ek anlamda \u00e7al\u0131\u015fmas\u0131n\u0131 engeller.\n<\/p>\n<\/div>\n\n<h2 id=\"birden-fazla\">Bir Firmada Birden Fazla PRRC Olabilir mi?<\/h2>\n\n<p>\nEvet. MDR, birden fazla ki\u015finin PRRC sorumluluklar\u0131n\u0131 payla\u015fmas\u0131na izin verir.\n<\/p>\n\n<p>\nAncak birden fazla PRRC varsa her ki\u015finin sorumluluk alan\u0131\n<strong>yaz\u0131l\u0131 olarak a\u00e7\u0131k\u00e7a belirlenmelidir.<\/strong>\n<\/p>\n\n<p>\u00d6rne\u011fin;<\/p>\n\n<ul>\n<li>bir PRRC teknik dok\u00fcmantasyon ve \u00fcr\u00fcn serbest b\u0131rakma,<\/li>\n<li>di\u011fer PRRC PMS ve vigilance<\/li>\n<\/ul>\n\n<p>\nalanlar\u0131ndan sorumlu olabilir.\n<\/p>\n\n<p>\nFakat g\u00f6rev payla\u015f\u0131m\u0131 yap\u0131lmas\u0131 sorumluluklar\u0131n belirsiz b\u0131rak\u0131labilece\u011fi\nanlam\u0131na gelmez.\n<\/p>\n\n<h3>Bir \u015firket grubunda tek PRRC yeterli mi?<\/h3>\n\n<p>\nMDCG 2019-7 Rev.1&#8217;e g\u00f6re ayn\u0131 ana \u015firket alt\u0131nda birden fazla\n<strong>ayr\u0131 yasal \u00fcretici<\/strong> varsa her yasal \u00fcreticinin kendi PRRC\ngereklili\u011fini kar\u015f\u0131lamas\u0131 gerekir.\n<\/p>\n\n<p>\nDolay\u0131s\u0131yla grup \u015firketinde tek bir kalite departman\u0131 bulunmas\u0131,\nher yasal \u00fcreticinin Madde 15 y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fcn\u00fc otomatik olarak kar\u015f\u0131lamaz.\n<\/p>\n\n<h2>Bir Ki\u015fi Birden Fazla Firmaya D\u0131\u015f PRRC Hizmeti Verebilir mi?<\/h2>\n\n<p>\nMikro veya k\u00fc\u00e7\u00fck \u00fcreticilere d\u0131\u015far\u0131dan PRRC hizmeti veren ki\u015finin birden fazla\nkurulu\u015fla \u00e7al\u0131\u015fmas\u0131 tek ba\u015f\u0131na yasaklanm\u0131\u015f de\u011fildir.\n<\/p>\n\n<p>\nAncak ki\u015finin her kurulu\u015f i\u00e7in ger\u00e7ekten\n<strong>s\u00fcrekli ve devaml\u0131 eri\u015filebilirlik<\/strong> \u015fart\u0131n\u0131 sa\u011flayabildi\u011finin\ng\u00f6sterilebilmesi gerekir.\n<\/p>\n\n<p>\n\u00c7ok say\u0131da firmada yaln\u0131zca isim olarak PRRC g\u00f6r\u00fcnmek ancak teknik dosyaya,\nPMS kay\u0131tlar\u0131na ve kritik s\u00fcre\u00e7lere fiilen eri\u015fememek Madde 15&#8217;in amac\u0131na\nuygun de\u011fildir.\n<\/p>\n\n<h2 id=\"ar\">Yetkili Temsilcinin de PRRC&#8217;si Olmal\u0131 m\u0131?<\/h2>\n\n<p>\nEvet. MDR Madde 15(6) uyar\u0131nca yetkili temsilciler de gerekli uzmanl\u0131\u011fa\nsahip en az bir PRRC&#8217;yi\n<strong>s\u00fcrekli ve devaml\u0131 olarak eri\u015filebilir<\/strong> bulundurmal\u0131d\u0131r.\n<\/p>\n\n<p>\nYetkili temsilcinin PRRC&#8217;sinin g\u00f6revi, yetkili temsilcinin \u00fcreticiyle yapt\u0131\u011f\u0131\nyetki s\u00f6zle\u015fmesi ve MDR Madde 11 kapsam\u0131nda \u00fczerine d\u00fc\u015fen g\u00f6revlerin\nyerine getirildi\u011fini g\u00fcvence alt\u0131na almakt\u0131r.\n<\/p>\n\n<h3>\u00dcreticinin PRRC&#8217;si ile Yetkili Temsilcinin PRRC&#8217;si ayn\u0131 ki\u015fi olabilir mi?<\/h3>\n\n<p>\n<strong>Hay\u0131r.<\/strong>\n<\/p>\n\n<p>\nMDCG 2019-7 Rev.1, AB d\u0131\u015f\u0131nda yerle\u015fik \u00fcreticinin PRRC&#8217;si ile\nayn\u0131 \u00fcreticinin yetkili temsilcisinin PRRC&#8217;sinin ayn\u0131 ki\u015fi olamayaca\u011f\u0131n\u0131\na\u00e7\u0131k \u015fekilde belirtir.\n<\/p>\n\n<p>\nBunun temel nedeni yetkili temsilcinin \u00fcretici \u00fczerinde ilave bir kontrol\nve g\u00f6zetim katman\u0131 olu\u015fturmas\u0131d\u0131r.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>Daha da \u00f6nemlisi:<\/strong>\n<p>\nMikro veya k\u00fc\u00e7\u00fck \u00fcretici d\u0131\u015far\u0131dan PRRC hizmeti kullan\u0131yorsa,\n\u00fcreticinin d\u0131\u015f PRRC&#8217;si ile yetkili temsilcinin PRRC&#8217;si ayn\u0131 d\u0131\u015f hizmet\nkurulu\u015funa da ba\u011fl\u0131 olmamal\u0131d\u0131r.\n<\/p>\n<\/div>\n\n<h2 id=\"turkiye\">T\u00fcrkiye&#8217;deki T\u0131bbi Cihaz \u00dcreticileri \u0130\u00e7in PRRC<\/h2>\n\n<p>\nT\u00fcrkiye&#8217;de \u00fcretim yapan ve MDR kapsam\u0131nda Avrupa Birli\u011fi pazar\u0131na cihaz sunan\nbir \u00fcretici a\u00e7\u0131s\u0131ndan PRRC konusu \u00f6zellikle dikkatli de\u011ferlendirilmelidir.\n<\/p>\n\n<p>\nMDCG 2019-7 Rev.1, PRRC ile \u00fcretim faaliyetleri aras\u0131nda\n<strong>s\u00fcrekli ve yak\u0131n bir ba\u011f<\/strong> bulunmas\u0131 gerekti\u011fini belirtir.\n<\/p>\n\n<p>\nBu nedenle;\n<\/p>\n\n<ul>\n<li>AB&#8217;de yerle\u015fik \u00fcreticinin PRRC&#8217;sinin AB&#8217;de,<\/li>\n<li>AB d\u0131\u015f\u0131nda yerle\u015fik \u00fcreticinin PRRC&#8217;sinin ise \u00fcreticiyle yak\u0131n co\u011frafi ili\u015fki sa\u011flayacak \u015fekilde AB d\u0131\u015f\u0131nda<\/li>\n<\/ul>\n\n<p>\nbulunmas\u0131 beklenir.\n<\/p>\n\n<p>\nT\u00fcrkiye&#8217;deki \u00fcretici i\u00e7in ayr\u0131ca AB&#8217;deki yetkili temsilcinin kendi\nba\u011f\u0131ms\u0131z PRRC y\u00fck\u00fcml\u00fcl\u00fc\u011f\u00fc bulunmaktad\u0131r.\n<\/p>\n\n<div class=\"kk-info\">\n<strong>T\u00fcrkiye&#8217;deki yap\u0131 basitle\u015ftirilmi\u015f \u015fekilde:<\/strong>\n<div class=\"kk-flow\">\n<span>T\u00fcrkiye&#8217;deki \u00dcretici<\/span>\n<span>\u2192<\/span>\n<span>\u00dcreticinin PRRC&#8217;si<\/span>\n<span>\u2192<\/span>\n<span>AB Yetkili Temsilci<\/span>\n<span>\u2192<\/span>\n<span>Yetkili Temsilcinin Ayr\u0131 PRRC&#8217;si<\/span>\n<\/div>\n<\/div>\n\n<h2 id=\"eudamed\">PRRC Bilgileri EUDAMED&#8217;e Girilir mi?<\/h2>\n\n<p>\nEvet. MDR Annex VI Part A kapsam\u0131nda ekonomik operat\u00f6r kay\u0131t bilgilerinin\ni\u00e7erisinde Madde 15&#8217;te belirtilen PRRC veya PRRC&#8217;lerin;\n<\/p>\n\n<ul>\n<li>ad\u0131,<\/li>\n<li>adresi ve<\/li>\n<li>ileti\u015fim bilgileri<\/li>\n<\/ul>\n\n<p>\nyer almaktad\u0131r.\n<\/p>\n\n<p>\nBu nedenle PRRC atamas\u0131 yaln\u0131zca \u015firket i\u00e7erisinde haz\u0131rlanan bir g\u00f6revlendirme\nformu olarak d\u00fc\u015f\u00fcn\u00fclmemelidir. D\u00fczenleyici ekonomik operat\u00f6r kay\u0131t yap\u0131s\u0131yla da\ndo\u011frudan ba\u011flant\u0131l\u0131d\u0131r.\n<\/p>\n\n<p>\nEUDAMED s\u00fcre\u00e7leri hakk\u0131nda\n<a href=\"\/en\/service\/eudamed-urun-kayit\/\">\n<strong>KaliteKit EUDAMED \u00dcr\u00fcn Kay\u0131t Deste\u011fini<\/strong>\n<\/a>\ninceleyebilirsiniz.\n<\/p>\n\n<h2 id=\"atama\">PRRC Atamas\u0131 Nas\u0131l Dok\u00fcmante Edilmeli?<\/h2>\n\n<p>\nMDR yaln\u0131zca bir ki\u015finin ad\u0131n\u0131 organizasyon \u015femas\u0131na yazmay\u0131 yeterli bir\nPRRC sistemi olarak tan\u0131mlamaz.\n<\/p>\n\n<p>Uygulamada PRRC dosyas\u0131nda en az\u0131ndan \u015fu kan\u0131tlar\u0131n bulunmas\u0131 yararl\u0131 olacakt\u0131r:<\/p>\n\n<div class=\"kk-check\">\n<ol>\n<li>PRRC atama\/g\u00f6revlendirme yaz\u0131s\u0131,<\/li>\n<li>g\u00fcncel \u00f6zge\u00e7mi\u015f,<\/li>\n<li>diploma ve gerekli formal yeterlilik kay\u0131tlar\u0131,<\/li>\n<li>gerekiyorsa diploma e\u015fde\u011ferli\u011fine ili\u015fkin kan\u0131t,<\/li>\n<li>1 y\u0131l veya 4 y\u0131ll\u0131k deneyimi g\u00f6steren kay\u0131tlar,<\/li>\n<li>g\u00f6rev tan\u0131m\u0131,<\/li>\n<li>Madde 15(3) sorumluluk matrisi,<\/li>\n<li>organizasyon \u015femas\u0131,<\/li>\n<li>PRRC&#8217;nin bilgi ve dok\u00fcmana eri\u015fim yetkileri,<\/li>\n<li>birden fazla PRRC varsa yaz\u0131l\u0131 g\u00f6rev payla\u015f\u0131m\u0131,<\/li>\n<li>d\u0131\u015f PRRC ise hizmet s\u00f6zle\u015fmesi,<\/li>\n<li>s\u00fcrekli ve devaml\u0131 eri\u015filebilirli\u011fin nas\u0131l sa\u011flanaca\u011f\u0131n\u0131 g\u00f6steren d\u00fczenleme,<\/li>\n<li>yedekleme\/devir yakla\u015f\u0131m\u0131,<\/li>\n<li>EUDAMED ekonomik operat\u00f6r kayd\u0131ndaki PRRC bilgilerinin g\u00fcncelli\u011fi.<\/li>\n<\/ol>\n<\/div>\n\n<h2>PRRC Denetiminde Hangi Kan\u0131tlar Sorulabilir?<\/h2>\n\n<p>\nBir denet\u00e7inin yaln\u0131zca \u201cPRRC&#8217;niz kim?\u201d diye sorup ki\u015finin ad\u0131n\u0131 \u00f6\u011frenmekle\nyetinmesini beklememek gerekir.\n<\/p>\n\n<p>Denetimde \u015fu sorular g\u00fcndeme gelebilir:<\/p>\n\n<ul>\n<li>PRRC hangi Madde 15 yeterlilik yoluyla atanm\u0131\u015ft\u0131r?<\/li>\n<li>Diplomas\u0131 ve deneyimi nas\u0131l kan\u0131tlanm\u0131\u015ft\u0131r?<\/li>\n<li>PRRC&#8217;nin g\u00f6rev tan\u0131m\u0131 var m\u0131?<\/li>\n<li>\u00dcr\u00fcn serbest b\u0131rakma s\u00fcrecine nas\u0131l dahil oluyor?<\/li>\n<li>Teknik dosya de\u011fi\u015fikliklerinden nas\u0131l haberdar oluyor?<\/li>\n<li>PMS sonu\u00e7lar\u0131na eri\u015fimi var m\u0131?<\/li>\n<li>Vigilance kararlar\u0131nda rol\u00fc nedir?<\/li>\n<li>PRRC bir uygunsuzluk tespit etti\u011finde kime eskalasyon yap\u0131yor?<\/li>\n<li>PRRC yokken kritik bir olay meydana gelirse s\u00fcre\u00e7 nas\u0131l devam ediyor?<\/li>\n<li>D\u0131\u015f PRRC ise firmaya ne kadar h\u0131zl\u0131 eri\u015febiliyor?<\/li>\n<\/ul>\n\n<p>\nBu nedenle PRRC atamas\u0131n\u0131n yaln\u0131zca personel klas\u00f6r\u00fcnde duran bir belge de\u011fil,\n<strong>KYS i\u00e7erisinde \u00e7al\u0131\u015fan bir s\u00fcre\u00e7<\/strong> olarak tasarlanmas\u0131 gerekir.\n<\/p>\n\n<h2>PRRC, \u00dcr\u00fcn\u00fcn Serbest B\u0131rak\u0131lmas\u0131n\u0131 \u0130mzalamak Zorunda m\u0131?<\/h2>\n\n<p>\nMDR, PRRC i\u00e7in b\u00fct\u00fcn cihazlarda kullan\u0131lacak belirli bir\n<strong>\u201cPRRC \u00fcr\u00fcn serbest b\u0131rakma imzas\u0131\u201d<\/strong> format\u0131 tan\u0131mlamaz.\n<\/p>\n\n<p>\nMadde 15(3)(a)&#8217;daki temel y\u00fck\u00fcml\u00fcl\u00fck, cihaz piyasaya verilmeden \u00f6nce uygunlu\u011funun\n\u00fcretimin ger\u00e7ekle\u015ftirildi\u011fi kalite y\u00f6netim sistemi do\u011frultusunda uygun \u015fekilde\nkontrol edildi\u011finin g\u00fcvence alt\u0131na al\u0131nmas\u0131d\u0131r.\n<\/p>\n\n<p>\nKurulu\u015f bu g\u00fcvenceyi kendi KYS yap\u0131s\u0131na uygun kontrol, g\u00f6zden ge\u00e7irme,\n\u00f6rnekleme, denetim veya kay\u0131t mekanizmalar\u0131yla dok\u00fcmante edebilir.\n<\/p>\n\n<div class=\"kk-warning\">\n<strong>PRRC&#8217;yi her dok\u00fcman\u0131n alt\u0131na imza atan ki\u015fiye d\u00f6n\u00fc\u015ft\u00fcrmek do\u011fru yakla\u015f\u0131m de\u011fildir.<\/strong>\nAs\u0131l konu imza say\u0131s\u0131 de\u011fil, PRRC&#8217;nin Madde 15 kapsam\u0131ndaki kontrolleri\nger\u00e7ekten ger\u00e7ekle\u015ftirebilecek sistem, bilgi ve yetkiye sahip olmas\u0131d\u0131r.\n<\/div>\n\n<h2>PRRC Atarken En S\u0131k Yap\u0131lan Hatalar<\/h2>\n\n<h3>1. Yaln\u0131zca e\u011fitim sertifikas\u0131na bakmak<\/h3>\n<p>\n\u00dc\u00e7 g\u00fcnl\u00fck PRRC e\u011fitimi Madde 15&#8217;teki 1 veya 4 y\u0131ll\u0131k profesyonel deneyimin\nyerini tutmaz.\n<\/p>\n\n<h3>2. Her sekt\u00f6r deneyimini t\u0131bbi cihaz deneyimi saymak<\/h3>\n<p>\nDeneyimin medical device regulatory affairs veya medical device QMS ile\nili\u015fkili olmas\u0131 gerekir.\n<\/p>\n\n<h3>3. D\u00f6rt y\u0131l \u00e7al\u0131\u015fm\u0131\u015f olmay\u0131 yeterli kabul etmek<\/h3>\n<p>\nD\u00f6rt y\u0131l\u0131n hangi g\u00f6revlerle ge\u00e7irildi\u011finin belgelenmesi gerekir.\n<\/p>\n\n<h3>4. Mikro i\u015fletmenin PRRC&#8217;den tamamen muaf oldu\u011funu d\u00fc\u015f\u00fcnmek<\/h3>\n<p>\nMuafiyet PRRC&#8217;den de\u011fil, PRRC&#8217;yi organizasyon i\u00e7erisinde bulundurma\nzorunlulu\u011fundand\u0131r.\n<\/p>\n\n<h3>5. D\u0131\u015f PRRC&#8217;ye dok\u00fcman eri\u015fimi vermemek<\/h3>\n<p>\nTeknik dosyay\u0131, PMS kay\u0131tlar\u0131n\u0131 veya kritik uygunsuzluklar\u0131 g\u00f6remeyen bir\nPRRC&#8217;nin sorumluluklar\u0131n\u0131 etkili \u015fekilde yerine getirmesi m\u00fcmk\u00fcn de\u011fildir.\n<\/p>\n\n<h3>6. \u00dcretici ve yetkili temsilci i\u00e7in ayn\u0131 PRRC&#8217;yi kullanmak<\/h3>\n<p>\nAB d\u0131\u015f\u0131ndaki \u00fcretici ile yetkili temsilcisinin PRRC&#8217;si ayn\u0131 ki\u015fi olamaz.\n<\/p>\n\n<h3>7. PRRC&#8217;yi yaln\u0131zca denetim \u00f6ncesinde sisteme dahil etmek<\/h3>\n<p>\nPRRC s\u00fcrekli i\u015fleyen kalite ve reg\u00fclasyon s\u00fcre\u00e7lerinin par\u00e7as\u0131 olmal\u0131d\u0131r.\n<\/p>\n\n<div class=\"kk-cta\">\n<h2>MDR S\u00fcrecinizde PRRC&#8217;nin Yeri<\/h2>\n\n<p>\nPRRC atamas\u0131; teknik dosya, kalite y\u00f6netim sistemi, PMS, vigilance,\nuygunluk beyan\u0131 ve EUDAMED s\u00fcre\u00e7lerinden ba\u011f\u0131ms\u0131z d\u00fc\u015f\u00fcn\u00fclmemelidir.\n<\/p>\n\n<a href=\"\/en\/tibbi-cihaz-ce-belgesi-nasil-alinir\/\">MDR \/ CE S\u00fcrecini \u0130ncele<\/a>\n<a href=\"\/en\/mdr-uyumlu-teknik-dosya-technical-documentation-hazirlama-rehberi\/\">Teknik Dosya Rehberi<\/a>\n<a href=\"\/en\/post-market-surveillance-pms-ve-vigilance-sureci-mdr-uyumunda-kritik-adimlar\/\">PMS ve Vigilance<\/a>\n<a href=\"\/en\/service\/eudamed-urun-kayit\/\">EUDAMED S\u00fcreci<\/a>\n<\/div>\n\n<h2 id=\"sss\">PRRC Hakk\u0131nda S\u0131k Sorulan Sorular<\/h2>\n\n<div class=\"kk-faq\">\n<h3>PRRC nedir?<\/h3>\n<p>\nPRRC, Person Responsible for Regulatory Compliance ifadesinin k\u0131saltmas\u0131d\u0131r.\nMDR ve IVDR Madde 15 kapsam\u0131nda \u00fcretici veya yetkili temsilcinin belirli\nmevzuat uyum y\u00fck\u00fcml\u00fcl\u00fcklerini g\u00fcvence alt\u0131na alan ki\u015fidir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>PRRC olmak i\u00e7in ka\u00e7 y\u0131l deneyim gerekir?<\/h3>\n<p>\nUygun formal yeterlilik varsa en az 1 y\u0131l; bu akademik yeterlilik yolu\nkullan\u0131lm\u0131yorsa en az 4 y\u0131l t\u0131bbi cihaz regulatory affairs veya kalite\ny\u00f6netim sistemi deneyimi gerekir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>Biyoloji mezunu PRRC olabilir mi?<\/h3>\n<p>\nMDR, hukuk, t\u0131p, eczac\u0131l\u0131k ve m\u00fchendisli\u011fin yan\u0131nda ba\u015fka bir ilgili bilimsel\ndisipline de izin vermektedir. Biyoloji bu kapsamda de\u011ferlendirilebilir;\nancak diploman\u0131n uygunlu\u011fu tek ba\u015f\u0131na yeterli de\u011fildir. \u0130lgili bilimsel\ndisiplin olmas\u0131n\u0131n gerek\u00e7elendirilmesi ve akademik yol kullan\u0131l\u0131yorsa\nen az bir y\u0131ll\u0131k uygun profesyonel deneyimin ayr\u0131ca kan\u0131tlanmas\u0131 gerekir.\nAB d\u0131\u015f\u0131nda al\u0131nan diploma bak\u0131m\u0131ndan MDCG 2019-7 Rev.1&#8217;deki tan\u0131nma\ngereklili\u011fi de dikkate al\u0131nmal\u0131d\u0131r.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>PRRC sertifikas\u0131 almak yeterli mi?<\/h3>\n<p>\nHay\u0131r. Bir PRRC e\u011fitim sertifikas\u0131 Madde 15&#8217;te tan\u0131mlanan formal yeterlilik\nve profesyonel deneyim \u015fartlar\u0131n\u0131n yerine ge\u00e7mez.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>ISO 13485 deneyimi PRRC deneyimi say\u0131l\u0131r m\u0131?<\/h3>\n<p>\nT\u0131bbi cihazlara ili\u015fkin kalite y\u00f6netim sistemi alan\u0131nda somut profesyonel\ndeneyim Madde 15 a\u00e7\u0131s\u0131ndan de\u011ferlendirilebilir. Ancak yaln\u0131zca ISO 13485\ne\u011fitim sertifikas\u0131na sahip olmak profesyonel deneyim de\u011fildir.\nKi\u015finin t\u0131bbi cihaz KYS s\u00fcre\u00e7lerinde fiilen y\u00fcr\u00fctt\u00fc\u011f\u00fc g\u00f6revler kan\u0131tlanmal\u0131d\u0131r.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>Kalite m\u00fcd\u00fcr\u00fc PRRC olabilir mi?<\/h3>\n<p>\nEvet. Madde 15 yeterlilik \u015fartlar\u0131n\u0131 kar\u015f\u0131layan bir kalite m\u00fcd\u00fcr\u00fc PRRC olarak\natanabilir. \u201cKalite M\u00fcd\u00fcr\u00fc\u201d unvan\u0131n\u0131n bulunmas\u0131 tek ba\u015f\u0131na yeterli de\u011fildir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>PRRC firma \u00e7al\u0131\u015fan\u0131 olmak zorunda m\u0131?<\/h3>\n<p>\nMikro ve k\u00fc\u00e7\u00fck i\u015fletme istisnas\u0131 d\u0131\u015f\u0131nda \u00fcreticinin PRRC&#8217;sinin organizasyon\ni\u00e7erisinde bulunmas\u0131 gerekir ve MDCG 2019-7 Rev.1 bunu \u00e7al\u0131\u015fan olarak a\u00e7\u0131klar.\nMikro ve k\u00fc\u00e7\u00fck i\u015fletmeler ise nitelikli ki\u015fiyi s\u00fcrekli ve devaml\u0131 olarak\neri\u015filebilir bulundurmak \u015fart\u0131yla d\u0131\u015f PRRC kullanabilir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>D\u0131\u015far\u0131dan PRRC hizmeti al\u0131nabilir mi?<\/h3>\n<p>\nMikro ve k\u00fc\u00e7\u00fck \u00fcreticiler a\u00e7\u0131s\u0131ndan evet. Ancak PRRC&#8217;nin yeterlilik \u015fartlar\u0131n\u0131\nta\u015f\u0131mas\u0131, s\u00fcrekli ve devaml\u0131 eri\u015filebilir olmas\u0131 ve bu ili\u015fkinin uygun \u015fekilde\ndok\u00fcmante edilmesi gerekir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>Bir ki\u015fi birden fazla firman\u0131n PRRC&#8217;si olabilir mi?<\/h3>\n<p>\nD\u0131\u015f PRRC kullanmas\u0131na izin verilen kurulu\u015flar a\u00e7\u0131s\u0131ndan bu durum otomatik olarak\nyasak de\u011fildir. Ancak ki\u015finin her \u00fcretici i\u00e7in s\u00fcrekli eri\u015filebilir oldu\u011funu ve\nMadde 15 sorumluluklar\u0131n\u0131 etkili bi\u00e7imde yerine getirebildi\u011fini g\u00f6sterebilmesi gerekir.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>PRRC ile yetkili temsilci ayn\u0131 ki\u015fi olabilir mi?<\/h3>\n<p>\nKavramlar farkl\u0131d\u0131r. Ayr\u0131ca AB d\u0131\u015f\u0131nda yerle\u015fik \u00fcreticinin PRRC&#8217;si ile\no \u00fcreticinin AB yetkili temsilcisinin PRRC&#8217;si ayn\u0131 ki\u015fi olamaz.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>PRRC&#8217;nin ad\u0131 EUDAMED&#8217;e girilir mi?<\/h3>\n<p>\nEvet. MDR Annex VI Part A kapsam\u0131nda ekonomik operat\u00f6r kay\u0131t bilgilerinde\nPRRC&#8217;nin ad\u0131, adresi ve ileti\u015fim bilgileri yer al\u0131r.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>PRRC teknik dosyay\u0131 haz\u0131rlamak zorunda m\u0131?<\/h3>\n<p>\nHay\u0131r. Teknik dosyan\u0131n tamam\u0131n\u0131 PRRC&#8217;nin \u015fahsen haz\u0131rlamas\u0131 gerekmez.\nPRRC, teknik dok\u00fcmantasyon ve AB Uygunluk Beyan\u0131n\u0131n haz\u0131rlanmas\u0131n\u0131 ve\ng\u00fcncel tutulmas\u0131n\u0131 g\u00fcvence alt\u0131na almakla sorumludur.\n<\/p>\n<\/div>\n\n<div class=\"kk-faq\">\n<h3>PRRC \u00fcr\u00fcn serbest b\u0131rakmay\u0131 imzalamak zorunda m\u0131?<\/h3>\n<p>\nMDR b\u00fct\u00fcn \u00fcreticiler i\u00e7in belirli bir PRRC serbest b\u0131rakma imzas\u0131 format\u0131\ntan\u0131mlamaz. PRRC, cihaz piyasaya verilmeden \u00f6nce uygunlu\u011funun KYS kapsam\u0131nda\nuygun \u015fekilde kontrol edildi\u011fini g\u00fcvence alt\u0131na almal\u0131d\u0131r.\n<\/p>\n<\/div>\n\n<h2>Sonu\u00e7: PRRC Bir Unvan De\u011fil, Kan\u0131tlanmas\u0131 Gereken Bir Yeterliliktir<\/h2>\n\n<p>\n<strong>PRRC kim olabilir?<\/strong> sorusunun cevab\u0131 yaln\u0131zca ki\u015finin diplomas\u0131na,\ni\u015f unvan\u0131na veya ald\u0131\u011f\u0131 e\u011fitim sertifikas\u0131na bak\u0131larak verilemez.\n<\/p>\n\n<p>\nDo\u011fru de\u011ferlendirme;\n<\/p>\n\n<div class=\"kk-flow\">\n<span>Formal Yeterlilik<\/span>\n<span>+<\/span>\n<span>\u0130lgili Mesleki Deneyim<\/span>\n<span>+<\/span>\n<span>Madde 15 G\u00f6revleri<\/span>\n<span>+<\/span>\n<span>Dok\u00fcman Eri\u015fimi<\/span>\n<span>+<\/span>\n<span>Yetki<\/span>\n<span>+<\/span>\n<span>S\u00fcreklilik<\/span>\n<\/div>\n\n<p>\n\u00fczerinden yap\u0131lmal\u0131d\u0131r.\n<\/p>\n\n<p>\n\u00d6zellikle T\u00fcrkiye&#8217;den Avrupa pazar\u0131na t\u0131bbi cihaz sunan \u00fcreticilerin;\nPRRC&#8217;nin akademik ve profesyonel yeterlili\u011fini, \u015firket b\u00fcy\u00fckl\u00fc\u011f\u00fcne g\u00f6re\ni\u00e7\/d\u0131\u015f PRRC modelini, AB yetkili temsilcisinin ayr\u0131 PRRC yap\u0131s\u0131n\u0131 ve\nEUDAMED kay\u0131tlar\u0131n\u0131 birlikte de\u011ferlendirmesi gerekir.\n<\/p>\n\n<hr>\n\n<section class=\"kk-source\">\n\n<h2>Resm\u00ee Kaynaklar<\/h2>\n\n<p>\nBu rehber haz\u0131rlan\u0131rken ba\u015fta MDR 2017\/745 Madde 15,\nIVDR 2017\/746 Madde 15 ve Avrupa Komisyonu\nMDCG 2019-7 Rev.1 rehberi esas al\u0131nm\u0131\u015ft\u0131r.\n<\/p>\n\n<p>\n<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\" target=\"_blank\" rel=\"noopener noreferrer\">\nRegulation (EU) 2017\/745 \u2013 MDR\n<\/a>\n<\/p>\n\n<p>\n<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/463b4f08-44a2-4018-9957-488bf386fc3a_en\" target=\"_blank\" rel=\"noopener noreferrer\">\nMDCG 2019-7 Rev.1 \u2013 Guidance on Article 15 \/ PRRC\n<\/a>\n<\/p>\n\n<p>\n<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/0a7613cb-6b9a-4396-a4c6-d2479e43e167_en\" target=\"_blank\" rel=\"noopener noreferrer\">\nMDCG 2022-16 \u2013 Guidance on Authorised Representatives\n<\/a>\n<\/p>\n\n<p>\n<strong>Son g\u00f6zden ge\u00e7irme:<\/strong> 14 Eyl\u00fcl 2026\n<\/p>\n\n<p>\n<strong>Bilgilendirme:<\/strong>\nBu i\u00e7erik genel bilgilendirme amac\u0131yla haz\u0131rlanm\u0131\u015ft\u0131r. PRRC yeterlili\u011fi;\nki\u015finin formal e\u011fitimi, e\u011fitimin tan\u0131nma durumu, mesleki deneyimin i\u00e7eri\u011fi,\ns\u00fcresi, g\u00fcncelli\u011fi, \u00fcreticinin bulundu\u011fu \u00fclke ve kurulu\u015f yap\u0131s\u0131 birlikte\nde\u011ferlendirilerek belirlenmelidir.\n<\/p>\n\n<\/section>\n\n<\/article>","protected":false},"excerpt":{"rendered":"<p>PRRC (Person Responsible for Regulatory Compliance), MDR 2017\/745 ve IVDR 2017\/746 kapsam\u0131nda \u00fcreticinin veya yetkili temsilcinin mevzuata uyum s\u00fcre\u00e7lerinde belirli [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[],"tags":[],"class_list":["post-18014","post","type-post","status-publish","format-standard","hentry"],"_links":{"self":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/18014","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/comments?post=18014"}],"version-history":[{"count":0,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/posts\/18014\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/media?parent=18014"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/categories?post=18014"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kalitekit.com.tr\/en\/wp-json\/wp\/v2\/tags?post=18014"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}