色综合色综合久久综合频道88丨欧美在线 | 亚洲丨蜜桃久久精品成人无码av丨九九精品99久久久香蕉丨无码中文av波多野结衣一区

(EU) 2017/745 Medical Device Regulation

(EU) 2017/745 Medical Device Regulation

In order to protect patient and user health, the European Union (EU) has made a major change in medical device directive with stricter requirements in order to improve quality, safety and performance data in medical devices and to harmonize all sector stakeholders, whether manufacturers, notified bodies or competent authorities. The New Medical Device Regulation came into force on May 25, 2017 and started to be implemented as of May 26, 2021 (DoA - Date of Application) with the completion of the four-year transition period. The implementation of the 93/42/EEC Medical Device Directive (MDD) has also ended as of this date.

 

 

Improvements under MDR

  • Stricter preliminary control for high-risk devices through a new pre-market review mechanism with a pool of experts at EU level;
  • Strengthening criteria for appointment and oversight of Notified Bodies
  • Including some aesthetic devices that have the same features and risk profile as similar medical devices within the scope of the regulation (Annex XVI);
  • Improved transparency through a comprehensive EU database on medical devices (EUDAMED)
  • A traceability system based on the UDI system;
  • Requirement for an “implant card” containing information for patients with implantable medical devices;
  • Strengthening the rules on clinical evidence, including an EU-wide coordinated procedure for authorizing multicenter clinical trials;
  • Strengthening post-market surveillance requirements for manufacturers;
  • Improved coordination mechanisms on vigilance and market surveillance among EU countries;
  • A robust financial compensation mechanism that allows patients to compensate for harm caused by defective devices.

It is important that the guidelines prepared by MDCG (Medical Device Coordination Group) regarding applications within the scope of MDR are followed and implemented by manufacturers and notified bodies. You can access the relevant guidelines via the link below.
https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

You can also access the Turkish translations of the relevant guidelines on the TITCK website below.
https://www.titck.gov.tr/faaliyetalanlari/tibbicihaz/tibbi-cihaz-mevzuati


Application Process

Before starting the medical device conformity assessment process, you must verify whether your product is a medical device according to the MDR medical device definition. If your product meets the definition of a medical device, you can check the conformity of the scope of notified bodies through the NANDO Information System to receive conformity assessment service.

You can access the UDEM (2292) MDR designation scope from the link below:
https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies/notifications/1004365?organizationVersion=7

You can access the pricing details regarding medical device conformity assessment activities carried out by UDEM A.?. through the MDR Standard Fee List document.

MDR Standard Fee List

APPLY NOW

To receive MDR conformity assessment service from UDEM A.?.; You can download and fill out the application form and send it to your e-mail address mdr@udem.com.tr.

You can access the Technical Documentation Content Guide document, which has been prepared for informational purposes for manufacturers, via the link below.

Technical Documentation Content Guide

Our Subcontractor Laboratories

1. AYA Validasyon Ambalaj Sterilizasyon A.?.

2. LVT Test Laboratuvarlar? Ltd. ?ti.

3. ERA Yönetim Test ve Belgelendirme Hiz. A.?.

4. Kobay Deney Hayvanlar? Laboratuvar? Sanayi ve Ticaret A.?.

5. Udem Uluslararas? Belgelendirme Denetim E?itim Merkezi San. ve Tic. A.?. - Test Laboratory

 


UDEM Certificate

We crown our achievements with originality with our sector experience and expert personnel, we continue to be the choice of professionals.

Without compromising our principles of impartiality, independence and confidentiality, we aim to be a leader not only in Türkiye, but also in the global market, we are expanding our international network every day.

Continue on udemchina.cn.

Select the website you want to go to.

Any addresses, social media platforms, or online sources other than the specified websites do not belong to UDEM A.?. and do not reflect our organization's information. To avoid encountering false or misleading information, we recommend obtaining information only through these official websites.

We use cookies on this website to improve your user experiene. You will have accepted our use of cookies if you continue. Cookie Policy OK
主站蜘蛛池模板: 毛片24种姿势无遮无拦| 亚洲欧洲中文日韩乱码av| 无码视频一区二区三区| 狼人无码精华av午夜精品| 一本一道av无码中文字幕| 99国产成人精品视频| 日韩欧美激情兽交| 国产av一区二区三区日韩| 国产综合精品一区二区三区 | 久久久久亚洲精品中文字幕| 熟女视频一区二区在线观看 | 久久久久久a亚洲欧洲av| 欧洲极品无码一区二区三区 | 亚洲国产欧美在线观看片不卡| 内射人妻少妇无码一本一道 | 亚欧美无遮挡hd高清在线视频| 国产高潮流白浆免费观看| 欧美伦费免费全部午夜最新| 中文字幕人妻无码一夲道| 在线天堂中文在线资源网| 亚洲国产精品一区二区第四页| 久久高清超碰av热热久久| 熟妇人妻中文字幕无码老熟妇| 朝鲜女人大白屁股ass| 果冻传媒2021精品一区| 日韩99在线 | 中文| 亚洲精品乱码久久久久久蜜桃 | 特级做a爰片毛片免费看108| 三级成年网站在线观看级爱网| 97免费人妻在线视频| 日本va欧美va精品发布| 亚洲偷自拍国综合| 久久视频这里只精品99| 久天啪天天久久99久孕妇| 自拍偷自拍亚洲精品播放| 香港三级韩国三级日本三级| 国产成人精品久久一区二区| 97丨九色丨国产人妻熟女| 久久久久亚洲精品无码网址| 久久国产成人免费网站| 日本熟妇厨房xxxxx乱|