關於 mdr ivdr ，我們在網路上蒐集到這些相關的討論、資訊與評價

#11. Medical Device Definition (MDR/IVDR) - Advena Ltd

Medical Device Definition (MDR/IVDR). It is important to understand the definition of a Medical Device, or an In-Vitro Diagnostic Medical Device (IVD), ...

#12. MDR/IVDR Update - BD

All MDs and IVDs manufactured with a CE mark will be affected by the MDR and IVDR. The new regulations were developed in part as a response to rising concerns ...

#13. MDR / IVDR Information | NSAI

NSAI is now designated under Medical Device Regulation 2017/745 · MDR and IVDR Publications · MDCG Guidance Documents · Contact NSAI Medical Devices Email: medical ...

#14. The new MDR and IVDR, consequences for manufacturers

The new EU Medical Devices Regulation (MDR) imposes more and stricter rules on medical devices, effective 26 May 2021 across the European Union.

#15. 歐盟MDCG發布EMDN問答集

歐盟MDCG小組於今年6月發布EMDN (European Medical Device Nomenclature)相關的問答集(MDCG 2021-12)。EMDN的建立是基於MDR第26條以及IVDR第23條的 ...

#16. New medical devices regulations - Swissmedic

... force on 26 May 2017 and shall apply after graduated transitional periods, ranging from 6 months to 5 years, in Spring 2021 (MDR) or Spring 2022 (IVDR), ...

#17. 歐盟醫療器材法規(MDR)與單一識別系統要求

(MDR), April 5, 2017. Regulation (EU). 2017/746 (IVDR), April 5, 2017. 4. *Extension. [1]AIMDD/MDD certificates will generally remain valid until their ...

#18. MDR/IVDR Transition Subgroup - CAMD

About the MDR/IVDR Transition Subgroup. The key objectives of the Transition Subgroup are to: identify areas with the potential for inconsistent application ...

#19. 歐盟MDR/IVDR - Hukui Biotechnology Co., Ltd

Home · 法規顧問; 歐盟MDR/IVDR. 聯絡資訊. 服務專線 +886-2- 2579-6538; 傳真 +886-2- 2579-6506; 地址： 10558 台北市松山區八德路三段2 號11 樓之1.

#20. EU builds out MDR, IVDR guidance ahead of flurry of ...

The push to back implementation of the EU's new medical device and looming in vitro diagnostic regulations is coming at a steady pace this ...

#21. Update on Notified Bodies designation under MDR / IVDR

This blog provides an update on NB designation to MDR/IVDR and discusses some of the key challenges ahead.

#22. May's Regulatory Focus: EU MDR and EU IVDR update, and ...

Feature articles during May focused on the EU Medical Device Regulation (MDR) and the EU In Vitro Diagnostic Regulation (IVDR).

#23. MDR/IVDR transition - CE plus

MDR /IVDR transition. Needless to say, the new EU Regulation on medical devices (MDR 2017/745) and the EU ...

#24. MDR & IVDR Conference 19.10.2022 | Swiss Medtech

MDR & IVDR national Conference. Save already today the 19 October 2022 for the MDR & IVDR Conference in Bern. More information will follow at a later date.

#25. The ultimate guide to the EU MDR/IVDR UDI - Rimsys

A deep dive into the new EU UDI and EUDAMED systems that were introduced as part of the MDR and IVDR regulations in the European Union.

#26. Prepare for EU MDR/IVDR Compliance - Validant

No longer directives, but laws that enforce penalties, the European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) will ...

#27. EU MDR and IVDR Compliance - USDM Life Sciences

The European Union's EU Medical Device Regulation MDR and In Vitro Diagnostic Regulation IVDR solutions for medical device manufacturers.

#28. TIC Council publishes its recommendations to improve the ...

TIC Council publishes its recommendations to improve the MDR/IVDR transition process. TIC Council shares today with the European Commission its ...

#29. 當代醫藥法規月刊第95期

... 係將原有的醫療器材指令(MDD)、體外診斷醫材指令(IVDD)升級為歐盟醫療器材法(MDR, EU Medical Device Regulation 2017/745) [6] ，及體外診斷醫療器材法（IVDR, ...

#30. Classification of software under MDR and IVDR - AKRN ...

Qualification guidance of software as a Medical Device or In-vitro Diagnostic Device under the MDR and IVDR.

#31. MDR and IVDR establish new obligations for market participants

The purpose of the new regulation introduced by the MDR and IVDR is to increase safety and efficiency in the EU medical device market, including ...

#32. Latest Regulations for EU MDR & IVDR - Quality Support Group

EU MDR & IVDR sets forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU.

#33. MDR, IVDR and ISO 14155 clinical activity compliance support

MDR, IVDR and ISO 14155 clinical activity compliance support. Quality procedure set-up support and compliance review for EU clinical activities: Medical devices ...

#34. MDR/IVDR: Which supportive initiatives are available?

New regulations, such as the MDR and IVDR, not only provide the industry with opportunities like reorganizing and imroving processes.

#35. 製造商可能在等待MDR / IVDR審核的同時受益於MDSAP審核

This guidance document is targeted for notified bodies on use of MDASP audit reports in surveillance audit carried out under MDR/IVDR.

#36. Importers: What Do the MDR and IVDR Actually Demand?

The EU regulations the MDR and IVDR set out precise requirements for importers. And they also define who is an importer. Learn more!

#37. New EU MDR/IVDR Legislation - Medical Devices - HPRA

The MDR and IVDR represent a significant development and strengthening of the existing regulatory system for medical devices in Europe and will replace the ...

#38. Guidesheet for Importers and Distributors - Mindray

Introduction and Timeline of MDR/IVDR: The MDR will replace the existing medical devices Directive 93/42/ EEC (MDD) and active implantable medical devices ...

#39. MDR / IVDR Produktzulassung - EXCO (de)

Mit EXCO zur MDR / IVDR Compliance. 2017 sind die neue europäische Medical Device Regulation (MDR, Medizinprodukte-Verordnung) und die EU-Verordnung über ...

#40. EU MDR vs. IVDR (In Vitro Diagnostic Regulation) - Supplier ...

In contrast to the EU MDR, the IVDR covers diagnostic and monitoring devices that may attach to a person, but are specifically used for ...

#41. MDR and IVDR News | SGS

Read about the latest MDR and IVDR highlights and regulatory updates from SGS – a notified body for medical devices. Find out more.

#42. MedTech Report 2020: EU MDR and IVDR Compliance

This final report based on 265 responses reveals unique insights into the EU MDR and IVDR readiness of industry today as we head towards the key 2020 and ...

#43. EU MDR Planning & Execution | RQM+

Our new series of interactive tools allow you to easily filter lines of the IVDR and MDR by topic, chapter, section, article, and any search ...

#44. EU medical device regulations MDR/IVDR - orangeglobal

for medical technology and in-vitro diagnostic · EU medical device regulation: · Conformity assessment · MDR/IVDR versus MDD/AIMDD/IVDD · Other fundamental new ...

#45. MDR and IVDR: MedTech Europe calls for an extension of the ...

MDR and IVDR: MedTech Europe calls for an extension of the transitional provisions ... (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

#46. MDR-IVDR Awareness | HCL Technologies

The Global Healthcare Industry is going through a shift. Medical Devices companies are now building solutions / products keeping Patients at center and are ...

#47. 使用MDSAP模式进行MDR/IVDR审核 - Qserve

MDSAP报告提供了对制造商（QMS）是否符合ISO 13485要求以及许多其他类似于某些MDR / IVDR法规要求的详细评估。 若公告机构可以在MDR / IVDR审核中 ...

#48. EU Notified Bodies Under EU MDR 2017/745 and IVD 2017/746

UPDATED September 3, 2021. Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR.

#49. EU regulations IVDR and MDR | ICON plc

MDR takes effect and IVDR is around the corner - what manufacturers need to know. The European Union's new Medical Device Regulation (MDR) came into effect ...

#50. EU clearance for MDR and IVDR harmonised standards - mdi ...

EU clearance for MDR and IVDR harmonised standards ... 2017/746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR).

#51. 歐盟MDR及IVDR對於品質管理系統(Quality Management ...

歐盟醫療器材法規(MDR)和體外診斷醫療器材法規(IVDR)對於製造商的品質管理系統(Quality Management System, QMS)要求包括在第10條第9點(Article 10, ...

#52. EU MDR and EU IVDR Compliance Services | Medical Devices

Efficiently transition to EU MDR and EU IVDR while containing regulatory compliance costs and mitigating business risks with Tata Elxsi's EU MDR and IVDR ...

#53. IVDR – MDR Labelling differences: what symbols apply to IVDs

The Medical Devices Regulation 2017/745/EU ('MDR') and the In-vitro Devices Regulation 2017/746. (IVDR) both have new requirements for label and packaging of ...

#54. MDR and IVDR: Everything You Need to Know | RegDesk

A compiliation of informative articles related to implementation of new medical device regulations under MDR and IVDR.

#55. Your Regulatory Partner for Medical Devices - EU MDR and ...

Regulatory Globe is your regulatory affairs partner in regards to the new medical device regulation (EU MDR) and in-vitro diagnostic (IVDR).

#56. MDR與IVDR Basic UDI-DI定義及GS1 GMN編碼方式

歐盟MDR (2017/745) 與IVDR (2017/746) Annex VI Part C定義Basic UDI-DI是不同於UDI-DI，它是產品型號的主要識別，不是針對單一產品，而是針對一組類型的產品， ...

#57. Webinar to update current changes to MDR and IVDR - Med ...

Medilink Midlands will cover an update on the current changes to Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR) and ...

#58. EU MDR & IVDR | Kallik

EU MDR & IVDR · Breadcrumb · The new EU Medical Devices and In Vitro Diagnostical Medical Devices regulations are presenting huge challenges for medical device ...

#59. Delayed but not forgotten – MDR/IVDR should make you work ...

At 174 pages for MDR and 157 for IVDR, the new regulatory documents are physically 3 times longer than the 60-page predecessor, MDD, or the very ...

#60. BioStock's article series on MDR and IVDR: Notified Bodies

With the introduction of MDR and IVDR, the regulatory landscape in the EU for medical devices is undergoing tremendous change.

#61. MDR, IVDR, and Compliance: A Guide for Distributors

MDR, IVDR, and Compliance: A Guide for Distributors. To better view this article, click here. Page 1 / 5. Zoom 100%. Page 1 / 5. Zoom 100% ...

#62. MDR and IVDR - Are they a threat or opportunity for your ...

The Medical Devices Regulation (MDR) has been in force since May 2021. The In Vitro Diagnostic Medical Device Regulation (IVDR) replaces the ...

#63. 歐盟MDD及IVDD改版為新醫療器材法規(MDR)及體外診斷醫療 ...

歐盟新醫療器材法規（Medical Devices Regulations, MDR）以及體外診斷醫療器材法規（In Vitro Diagnostic Devices Regulations, IVDR）已於今年5月5 ...

#64. Greenlight Guru Announces True Quality Summit Series: EU ...

EU MDR & IVDR Virtual Summit Series - Press Release Graphic. INDIANAPOLIS — February 8, 2021 — Greenlight Guru, the leading medical device ...

#65. The “sell off” provision under the MDR and IVDR - Obelis Group

4 MDR & Art. 110 par. 4 IVDR). The purpose of such provision is to limit the time in which compliant devices already placed on the market prior to the date ...

#66. 生醫創業講座: 如何將對歐盟MDR & IVDR 法規的了解轉化為 ...

... 如何將對歐盟MDR & IVDR 法規的了解轉化為商業優勢為主題，帶來線上英文演講及同步Q&A問答，請想了解歐洲醫材法規的朋友不要錯過本次課程講座！

#67. EU Commission Proposes Codes for Medical Devices Under ...

EU Commission Proposes Codes for Medical Devices Under MDR/IVDR. In Compliance. October 26, 2017. The Commission of the European Union (EU) has issued a ...

#68. Compliance with the new EU MDR and IVDR - Capgemini

Europe is affected by the European Union (EU) Medical Device Regulations (MDR) and In-Vitro Diagnostic Regulations (IVDR) revoke existing ...

#69. [09B355]【科管局補助】歐盟CE MDR/IVDR 法規及其醫療器材 ...

【科管局補助】歐盟CE MDR/IVDR 法規及其醫療器材技術資料剖析.

#70. Nieuwe Europese verordeningen MDR en IVDR - Inspectie ...

Er zijn nieuwe Europese regels voor medische hulpmiddelen (MDR) en in-vitro diagnostica (IVDR). Doel van de nieuwe regels is de patiëntveiligheid te ...

#71. Post Market Surveillance and Vigilance New Requirements ...

Learn more about GMED's Post Market Surveillance and Vigilance New Requirements under the (EU) MDR/IVDR and view more events, conferences, ...

#72. Chemical Compliance Requirements for EU MDR ...

Did you know that both the new Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) for the European Union (EU) ...

#73. European Union: New MDCG guidance – MDR compliance of ...

European Union: New MDCG guidance – MDR compliance of legacy devices and ... devices under Article 16 MDR/IVDR (guidance document 2021-26).

#74. EU Medical Device and IVDR Training | NSF International

NSF International's training provides comprehensive instructions on regulation and identifies key topics and changes associated with the EU MDR and EU IVDR.

#75. MDR/ IVDR - In-Vitro Diagnostic Regulation - senetics

Prepare now for the challenges of the MDR and IVDR. Together with you we analyze your technical documentation and help you to resolve the evaluated gap!

#76. MDR & IVDR Soforthilfe BW

Die Verordnungen (EU) 2017/745 über Medizinprodukte (Medical Device Regulation, MDR) und (EU) 2017/746 über In-vitro-Diagnostika (In-vitro Diagnostics ...

#77. EU MDR and IVDR Conference

The MDR & IVDR EU Conference 2020 is dedicated to guidance and training for those impacted by the new Regulations to help you prepare to meet the timelines.

#78. Authorities in non-EU/EEA States - DNV.ae

The new Medical Devices Regulation (EU). 2017/745 (MDR) and the In Vitro Diagnostic. Medical Devices Regulations, (EU) 2017/746. (IVDR) bring EU ...

#79. Implementing EU MDR and IVDR Lessons Learned Part 2

Because EU MDR and EU IVDR do not allow grandfathering, all new requirements – including additional information that must be gathered and ...

#80. 基礎歐盟醫材MDR，看這篇就夠了!(1) - 什麼是MDR?

而觸發MDR產生的原因，正是PIP事件。下面的圖可以簡單解釋，MDD、AIMD、IVDD、IVDR和MDR的方向。

#81. More time to wait until the EU MDR and IVDR are ready | UL

The European Council has reached a political agreement on the proposed/draft Medical Devices and IVD Regulations. The press release, issued May 25th, ...

#82. MHRA guidance on the health institution exemption (HIE)

on in house manufacture continues to apply until May 2021 (MDR) and May 2022. (IVDR) when they will fully apply in Northern Ireland.

#83. Almost three-quarters of medical device companies ready to ...

44% of organizations admit the MDR and IVDR regulations are their top ... they have put in place to complete EU MDR/EU IVDR compliance.

#84. ‎在App Store 上的「Regulatory Globe MDR / IVDR」

閱讀評論、比較客戶評分、查看截圖，並進一步瞭解「Regulatory Globe MDR / IVDR」。下載「Regulatory Globe MDR / IVDR」並在iPhone、iPad 和iPod touch 上盡享豐富 ...

#85. Q&A document on the implementation of the MDR and IVDR

Q&A document on the implementation of the MDR and IVDR ... devices (MDR) and the in vitro diagnostic medical devices (IVDR) regulations.

#86. 【奥译言】有关MDR/IVDR公告机构的最新消息：欧盟发布指定 ...

【奥译言】有关MDR/IVDR公告机构的最新消息：欧盟发布指定当局的最终评估表 ... 法规（MDR）（2020年5月施行）和体外诊断医疗器械法规（IVDR）（2022 ...

#87. The HPRA published a MDR/IVDR Guide for Distributors of ...

The Guide addresses and clarifies the obligations which will be applicable to distributors of medical devices under the MDR and the IVDR. The ...

#88. EU MDR IVDR | Destination Labeling - Innovatum

EU MDR regulations create some unique challenges. Innovatum's EU MDR IVDR solutions, extensive experience, and industry leadership make all the difference.

#89. The New, Stringent MDR and IVDR Regulations - PubMed

The New, Stringent MDR and IVDR Regulations: Viewing this Change as an Opportunity. Chimia (Aarau). 2018 Jun 27;72(6):430-431. doi: 10.2533/chimia.2018.430.

#90. EC 'Rolling Plan' for MDR & IVDR Regulations | EUCOPE AISBL

News - November 15, 2018. The European Commission publishes a 'Rolling Plan' for MDR & IVDR Regulations. Following the last Medical Devices Coordination ...

#91. MDR / IVDR Transitional Regime: Timing is All! | Fieldfisher

It is less than 2 years before MDR and 4 years before IVDR become fully applicable, and medical devices manufacturers requiring notified body ...

#92. MDR/IVDR Rollout And Challenges—2021 Year In Review

With the MDR sprint mercifully behind them, medtech firms must now turn their attention to the next leg of Europe's revamped regulatory ...

#93. EN ISO 13485 Linked To MDR and IVDR At Last - Medtech ...

Nearly four months after the full application date of the EU's Medical Device Regulation, the EU standards bodies have updated the most ...

#94. Europe - EU MDR/IVDR Coordination Group Urges Exemption ...

Europe – EU MDR/IVDR Coordination Group Urges Exemption Clarification ... in Article 54(2) of the EU's medical device regulation (MDR), ...

#95. New EU Medical Devices Regulation/In Vitro Diagnostics ...

The MDR/IVDR obligates the manufacturer or authorized representative in the EU to generate the technical documentation and sign the declaration ...

#96. MDR / IVDR - BASG

Die beiden Verordnungen (EU) 2017/745 über Medizinprodukte (MDR) und (EU) 2017/746 über In-vitro-Diagnostika (IVDR) sind am 25.05.2017 in Kraft getreten.

#97. MDR / IVDR Implementation Rolling Plan - Qarad

MDR / IVDR Implementation Rolling Plan. 2018/10/17. The European Commission has published a "rolling plan" which provides deadlines and a state-of-play for ...

#98. MDR and IVDR - IMARC Research

Two big deadlines are looming for manufacturers who do business in Europe: the EU Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation ...

#99. European Medical Device Regulations MDR & IVDR - Lean ...

The current edition focuses on the new Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). By ...