TIBBİ CİHAZ YÖNETMELİĞİ (93/42/AT)
26 Mayıs 2021 tarihinden itibaren, 93/42/AT sayılı Tıbbi Cihaz Yönetmeliği (MDD) kapsamında atanmış olan onaylanmış kuruluşumuz MDD kapsamında yeni belge düzenleyememektedir.
(AB) 2017/745 sayılı Tıbbi Cihaz Regülasyonu ‘nün (MDR) 120. Maddesinde belirtildiği üzere geçiş sürecinde yalnızca MDD kapsamında geçerli bir şekilde düzenlenen belgeler için gözetim faaliyetlerinin yürütülmesine izin verilmektedir.
(AB) 2017/745 sayılı Tıbbi Cihaz Regülasyonu Hakkında
Firmaların, 26 Mayıs 2021 tarihi sonrasında 93/42/AT Tıbbi Cihazlar Yönetmeliği kapsamında düzenlenmiş belgeleri üzerinde değişikliğe sebep olacak başvuruları (kapsam genişletme, tasarım değişikliği, adres değişikliği vb.) ya da ilk belgelendirme talepleri olması durumunda (AB) 2017/745 sayılı Tıbbi Cihazlar Regülasyonu (MDR) kapsamında atanmış onaylanmış kuruluşlara başvuru yapması gerekmektedir.
Tıbbi Cihaz Yönetmeliği geçiş süreci hakkında bilgilendirme
02.06.2021 tarih ve 31499 (Mükerrer) sayılı Resmî Gazete’de yayımlanan Tıbbi Cihaz Yönetmeliği Madde 110 ile 7/6/2011 tarihli ve 27957 sayılı Resmî Gazete’de yayımlanan Tıbbi Cihaz Yönetmeliği yürürlükten kaldırılmıştır.
Yürürlükten kaldırılan Tıbbi Cihaz Yönetmeliği (93/42/AT) kapsamında onaylanmış kuruluşumuz tarafından düzenlenen belgeler, belge üzerinde belirtilen belge geçerlilik tarihine (en geç 26 Mayıs 2024) kadar geçerli olacaktır. Onaylanmış kuruluşumuz geçerli belge kapsamındaki tıbbi cihaz ile ilgili uygulanabilir gerekliliklerin tümüne yönelik gerekli gözetimi gerçekleştirmeye devam edecektir. 02.06.2021 tarih ve 31499 (Mükerrer) sayılı Resmi Gazete’de yayımlanan Tıbbi Cihaz Yönetmeliğinin (2017/745 sayılı Tıbbi Cihazlar Regülasyonu) piyasaya arz sonrası gözetim, piyasa gözetimi ve denetimi, vijilans, iktisadi işletmecilerin ve cihazların kaydı ile ilgili gereklilikleri; yürürlükten kaldırılan Tıbbi Cihaz Yönetmeliğindeki (93/42/AT) ilgili gerekliliklerin yerine uygulanır. Geçerli belge kapsamındaki tıbbi cihazların piyasaya arz edilebilmesi için tasarım ya da amaçlanan kullanımda önemli değişiklik yapılmaması gerekmektedir.
Başvuru Alınmamaktadır.
Tel: 90 – 312 416 64 61
Fax: 90 – 312 416 6282
Direktif Müdürlüğü genel mail adresi: ce@tse.org.tr
Direktifler Müdürü telefon numarası: 0312 416 64 99
Adres: Necatibey Caddesi No: 112 Bakanlıklar / Ankara
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To fulfill this, we aim to adhere as strictly as possible to the World Wide Web Consortium’s (W3C) Web Content Accessibility Guidelines 2.1 (WCAG 2.1) at the AA level. These guidelines explain how to make web content accessible to people with a wide array of disabilities. Complying with those guidelines helps us ensure that the website is accessible to all people: blind people, people with motor impairments, visual impairment, cognitive disabilities, and more.
This website utilizes various technologies that are meant to make it as accessible as possible at all times. We utilize an accessibility interface that allows persons with specific disabilities to adjust the website’s UI (user interface) and design it to their personal needs.
Additionally, the website utilizes an AI-based application that runs in the background and optimizes its accessibility level constantly. This application remediates the website’s HTML, adapts Its functionality and behavior for screen-readers used by the blind users, and for keyboard functions used by individuals with motor impairments.
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Our website implements the ARIA attributes (Accessible Rich Internet Applications) technique, alongside various different behavioral changes, to ensure blind users visiting with screen-readers are able to read, comprehend, and enjoy the website’s functions. As soon as a user with a screen-reader enters your site, they immediately receive a prompt to enter the Screen-Reader Profile so they can browse and operate your site effectively. Here’s how our website covers some of the most important screen-reader requirements, alongside console screenshots of code examples:
Screen-reader optimization: we run a background process that learns the website’s components from top to bottom, to ensure ongoing compliance even when updating the website. In this process, we provide screen-readers with meaningful data using the ARIA set of attributes. For example, we provide accurate form labels; descriptions for actionable icons (social media icons, search icons, cart icons, etc.); validation guidance for form inputs; element roles such as buttons, menus, modal dialogues (popups), and others. Additionally, the background process scans all of the website’s images and provides an accurate and meaningful image-object-recognition-based description as an ALT (alternate text) tag for images that are not described. It will also extract texts that are embedded within the image, using an OCR (optical character recognition) technology. To turn on screen-reader adjustments at any time, users need only to press the Alt+1 keyboard combination. Screen-reader users also get automatic announcements to turn the Screen-reader mode on as soon as they enter the website.
These adjustments are compatible with all popular screen readers, including JAWS and NVDA.
Keyboard navigation optimization: The background process also adjusts the website’s HTML, and adds various behaviors using JavaScript code to make the website operable by the keyboard. This includes the ability to navigate the website using the Tab and Shift+Tab keys, operate dropdowns with the arrow keys, close them with Esc, trigger buttons and links using the Enter key, navigate between radio and checkbox elements using the arrow keys, and fill them in with the Spacebar or Enter key.Additionally, keyboard users will find quick-navigation and content-skip menus, available at any time by clicking Alt+1, or as the first elements of the site while navigating with the keyboard. The background process also handles triggered popups by moving the keyboard focus towards them as soon as they appear, and not allow the focus drift outside of it.
Users can also use shortcuts such as “M” (menus), “H” (headings), “F” (forms), “B” (buttons), and “G” (graphics) to jump to specific elements.
We aim to support the widest array of browsers and assistive technologies as possible, so our users can choose the best fitting tools for them, with as few limitations as possible. Therefore, we have worked very hard to be able to support all major systems that comprise over 95% of the user market share including Google Chrome, Mozilla Firefox, Apple Safari, Opera and Microsoft Edge, JAWS and NVDA (screen readers), both for Windows and for MAC users.
Despite our very best efforts to allow anybody to adjust the website to their needs, there may still be pages or sections that are not fully accessible, are in the process of becoming accessible, or are lacking an adequate technological solution to make them accessible. Still, we are continually improving our accessibility, adding, updating and improving its options and features, and developing and adopting new technologies. All this is meant to reach the optimal level of accessibility, following technological advancements. For any assistance, please reach out to