關於 mdd 93/42/eec ，我們在網路上蒐集到這些相關的討論、資訊與評價

#11. Medical Device Directive 93/42/EEC - Medcert

The Directive 93/42/EEC applies for the placing on the market and launching of medical devices and their accessories. Product placement on the market cannot be ...

#12. Medical Devices Directive 93/42/EEC - Intertek

The Medical Device Regulation (MDR) (2017/745) will replace the EU's current Medical Device Directive (93/42/EEC) and the EU's Directive on Active Implantable ...

#13. Medical Devices Directive - Wikipedia

The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise ...

#14. Clinical Investigation of the MDD 93/42/EEC (Annex X)

MDD 93/42/EEC (Medical Device Directive), amended by the 2007/47/EC, requires clinical data and an evaluation of that data to ensure the safety of the ...

#15. 歐盟EMA

(2) Directive 93/42/EEC concerning medical devices (MDD)醫療器材指令, 2007. (1)&(2)已更新為Regulation (EU) 2017/745 Medical Devices Regulations, (MDR) 歐盟 ...

#16. Tag Archives: Council Directive 93/42/EEC - Medical Device ...

ANNEX XVII. Correlation table. Council Directive 90/385/EEC, Council Directive 93/42/EEC, This Regulation.

#17. EU Medical Devices Directive - MDD 93/42/EEC and 2007/47 ...

Full text of the European Medical Devices Directive 93/42/EEC including amendments by 2007/47/EC. Interactive web page allows for in-page navigation from ...

#18. The Medical Devices Directive (MDD: 93/42/EC) - EMC testing

The Medical Devices Directive (MDD: 93/42/EC). The Medical Devices Directive is concerned with all medical devices, from sterile gloves to electronic ...

#19. Council Directive 93/42/EEC on medical devices - TUV Sud

important aspects and requirements contained in Directive 93/42/EEC incl. 2007/47/EC. What exactly is a medical device? Medical device means any instrument, ...

#20. MDD 93/42/EEC - SIQ

The Medical Device Directive 93/42/EEC regulates the area of medical devices for human use and includes non-active medical devices, non-active implants, ...

#21. Transitioning from MDD 93/42/EEC to MDR 2017/745 - 博客來

書名：Medical Device Regulations: Transitioning from MDD 93/42/EEC to MDR 2017/745，語言：英文，ISBN：9781774078082，作者：Naidoo, Shalinee， ...

#22. Medical Devices Directive Testing - MDD 93/42/EEC | F2 Labs

F2 Labs is your premier choice for medical device directive testing. Contact us today to learn how we can assist with MDD 93/42/EEC certification testing.

#23. Medical Device Directive 93/42/EWG (MDD) - Johner Institute

The MDD is the Medical Device Directive or 93/42/EEC. The number indicates the year of initial release (1993) and the consecutive number of directives in that ...

#24. Medical Devices Directive 93/42/EEC - cemarking.net

Description: The Medical Devices Directive aims to ensure the free movement of goods within the Community, while providing patients, users and third parties ...

#25. EU Council Directive 93/42/EEC - Medical Devices - CE ...

A Medical Device is defined in Directive (93/42/EEC) as ; Any instrument, apparatus, appliance, material or other article, whether used alone or in ...

#26. Guidance document - Classification of medical devices

Directive 93/42/EEC, as amended, allows for derogation from the classification rules outlined in its Annex IX in light of technical progress or on information.

#27. Medical Device Directive 93/42/EEC CE-Marking What ...

Only one name is allowed and is to be preceded by the EU Symbol for manufacturer. Conformity with Medical Device Directive 93/42/EEC is mandatory all devices ...

#28. mdd-93-42-eec - Baat Medical products b.v.

Mdd 93 42 eec for Medical Products ✓ 20+ years experience in Unique Device Identification ✓ Consulting for directive 93/42/eec ✓ Contact our experts ...

#29. 93/42/EEC(MDD)_百度百科

医疗器械Medical Devices Directive，指令名： 医疗器械的1993年6月14日理事会指令93/42/EEC，适用范围： 医疗器械和它们的附件。

#30. Medical Devices 93/42/CEE and Active Implantable ... - IMQ

Medical devices can be placed on the market or put into service only if they meet the requirements of Directive 93/42 /EEC and as amended, including the " ...

#31. Medical Devices Directive (MDD) 93/42/EEC – Explained

Information & Best Practice on the Medical Device Directive 93/42/EEC. The Articles and Annex's which detail the requirements for compliance.

#32. 93/42/EEC - mdc medical device certification GmbH

Summary list of harmonised standards under Directive 93/42/EEC for Medical devices (25.03.2020, Official Journal of the European Union: OJ L 90I) ...

#33. MDD 93/42/EEC - Pharma Systems

Tags: certificates, EN ISO 13485:2012, ISO 13485:2016, MDD 93/42/EEC, medical manufacturer. Become a Distributor! Get distributor access! Popular; Recent.

#34. Medical Device Classification, MDD 93/42/EEC, IVDD

... according to the Medical Device Directive (MDD) 93/42/EEC & In Vitro Medical Diagnostic Medical Devices Directive (IVDD) 98/79/EC.

#35. Medical Device Directive (MDD), Directive 93/42/EEC

Council Directive 93/42/EEC of 14 June 1993 Concerning medical devices.

#36. 医疗器械指令（MDD）93/42/EEC协调标准

所有作为指令基本要求符合性推断的协调标准均由欧盟委员会通过官方公报（OJ）发布，详细的协调标准清单请点击：Directive 93/42/EEC相关协调标准。

#37. [08B316]如何看懂歐盟醫療器材指令與法規(MDD 93/42/EEC ...

如何看懂歐盟醫療器材指令與法規(MDD 93/42/EEC & MDR 2017/745)

#38. 93/42/EEC医疗设备指令

Medical device is defined as 'any instrument, apparatus, device or other ... 医疗器械指令MDD 93/42/eec 附录九中详定18条规则，按医疗产品的危险程度，将产品分 ...

#39. 93/42/EEC – Medical Devices Directive, CE Marking for Europe

Manufacturers of Class I (sterile/measuring), IIa, IIb and III devices must obtain certification against the CE marking directive, 93/42/EEC, ...

#40. MDD 93-42-EEC 指令理解和实施培训 - 医疗器械

MDD 93-42 -EEC 指令理解和实施培训. 1993年6月14日理事会第93/42/EEC号指令 关于医疗器材 欧洲共同体理事会，依据欧洲经济体所制订的罗马条约，特别是第100a条规定， ...

#41. MDD 93/42/EEC) Archives - AKRN Consulting

MDD 93/42/EEC ). Articles – Resources – AKRN Social network. Articles. March 22, 2019. Do ...

#42. Medical Devices Directive 1993/42 / EEC - Ente Certificazione ...

The CE mark declares that the product complies with the applicable European directives. The Medical Device Directive 93/42/EEC (MDD) lists the essential safety, ...

#43. 新MDR醫療器材規定Regulation (EU)2017/745 - CE認證

... 26 日止將取代現行的醫療器材指令（Medical Device Directive, MDD, 93/42/EEC）和主動植入式醫療器材指令（Active Implantable Medical Device Directive, AIMD, ...

#44. MDD 93/42/EEC - DQS Hellas Ltd.

Certification Profile. Since 14th June 1998, Medical devices may only be marketed in the European Union, if the requirements of Directive 93/42/EEC (MDD) ...

#45. 30-0013-declaration-of-conformity-pfu.pdf - Auditdata

According to Medical Device Directive (MDD) 93/42/EEC. Manufacturer. Auditdata A/S. Dalbergstroeget 5-7. 2630 Taastrup. Denmark.

#46. CE Marking: Medical Devices Directive (MDD) 93/42/EEC

CE Marking: Medical Devices Directive (MDD) 93/42/EEC: Requirements for Furniture ... The Medical Devices Directive (MDD) has an extremely broad remit, ...

#47. MDD 93/42/EEC - SlideShare

Medical Device Directive (MDD) 93/42/EEC as amended by 2007/42/EC Pavan Kumar Malwade 01 April 2016 1.

#48. Medical Device Regulations: Transitioning from MDD 93/42 ...

Medical Device Regulations: Transitioning from MDD 93/42/EEC to MDR 2017/745 [Naidoo, Shalinee] on Amazon.com. *FREE* shipping on qualifying offers.

#49. Council Directive 93/42/EEC of 14 June 1993 concerning ...

This A11 introduces a revised Annex ZA & Annex ZZ to EN IEC 60601-2-83:2020 in view of offering it for citation in OJEU under MDD (93/42/EEC) and MDR ...

#50. Intended purpose as medical device - Memmert GmbH + Co. KG

Intended purpose Medical devices. Memmert successfully has passed the extension of the MDD 93/42/EEC certificates. The existing EC certificate, directive 93/42/ ...

#51. MEDICAL DEVICES : Guidance document - Team NB

1. The Directive 90/385/EEC on active implantable medical devices (AIMD) and the Directive. 93/42/EEC on medical devices (MDD) are "specific directives" with ...

#52. Medical Device Directive 93/42/EEC | SQS Switzerland

The conformity of medical devices must be assessed under EU Directive 93/42/EEC before they are placed on the market. One part of the conformity assessment ...

#53. Changes to the Medical Devices Directive: 93/42/EEC

This webinar will provide valuable assistance and guidance to medical device companies that are preparing for CE Mark and ensuring compliance to MDD ...

#54. 歐盟發布《醫療器材規章》（MDR）有關客製化醫材之釐清文件

... 178/2002）以及化妝品規章（Regulation(EC) 1223/2009），並廢止醫療器材指令（Directive 93/42/EEC, Medical Device Directive(MDD)）和主動植入 ...

#55. Medical Devices in the EU: CE Mark and 93/42/EEC Directive

This webinar will provide valuable assistance and guidance to all regulated companies that are preparing for CE Mark and ensuring compliance to MDD ...

#56. MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 ...

According to article 120(2) of Regulation (EU) 2017/475 on Medical Devices (the MDR), certificates issued in accordance with Directive 93/42/EEC ...

#57. 歐盟醫療器材法規(MDR)與單一識別系統要求 - 衛生福利部食品 ...

Medical Devices (MDD) Council. Directive 93/42/EEC on (1993) ... [1]AIMDD/MDD certificates will generally remain valid until their indicated expiry dates.

#58. Medical Device Directive, 93/42/EEC | Szutest.com

After assessment of the explanation of the change requested by the manufacturer with the MDD certificate issued by SZUTEST, it is confirmed in ...

#59. MDD 93/42/EEC certification - aXcent medical GmbH

aXcent medical achieves MDD 93/42/EEC certification. aXcent MDD 93/42/EEC Certificate (306.6 KiB). Go back. You would like to get in contact with us?

#60. Regulating medical devices in the UK - GOV.UK

Directive 93/42/EEC on medical devices (EU MDD); Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD). This means that the Great ...

#61. EC Declaration of Conformity according to MDD 93/42/EEC

Council Directive on the harmonization of the Laws of the Member States concerning Medical Device ... Annex II without section 4 (MDD 93/42/EEC).

#62. basic info mdd 93/42/eec | Heri Sutikno - Academia.edu

basic info mdd 93/42/eec. ... Basic Information about the European Directive 93/42/EEC on Medical Devices mdc medical device certification GmbH ...

#63. MDD Directive - 93/42/EEC

MDD Directive - 93/42/EEC. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. Description: The Medical Devices Directive aims to ensure ...

#64. Directive 93/42/EEC - Clinical Evaluation Report

The Medical Devices Directive 93/42/EEC (MDD) has been published by the Council on 14 June 1993 and is intended to harmonise the laws relating to medical ...

#65. Guide to Medical Device Directive Compliance (93/42/EEC)

The Medical Devices Directive (MDD) is a European CE-Directive that is replaced by the Regulation (EU) 2017/745. The Directive set standards ...

#66. The Medical Devices Directive (MDD) 93/42/EEC - Polmed.de

The Medical Devices Directive (MDD) 93/42/EEC Medical Devices means : “any instrument, apparatus, implement, machine, appliance, imp...

#67. Key note: EU Medical Devices Directive (MDD 93/42/EEC ...

Key note: EU Medical Devices Directive (MDD 93/42/EEC) and the coming. EU Medical Devices Regulation – similarities and expected differences.

#68. Definition of a Medical Device: Explainer - Acorn Regulatory

MDR 2017/245 covers devices that previously fell under two separate European directives, the Medical Devices Directive (MDD 93/42/EEC) and the Active ...

#69. THE TERMINOLOGICAL CHALLENGE OF THE MDD 93/42/EEC

2022年4月30日 — Request PDF | DIRECTIVES AND THE SWORN TRANSLATOR: THE TERMINOLOGICAL CHALLENGE OF THE MDD 93/42/EEC | The presentation addresses the field ...

#70. 歐盟MDR，全新醫療器材法規啟動 - 能邁科技

歐盟MDR(Medical Devices Regulation)法規取代舊有的MDD(Medical Devices Directive)醫療器材法(93/42/EEC)與AIMDD(Active Implantable Medical Devices Directive) ...

#71. Medical devices - all you need to know! ⚕️ MDR Regulator

Check FAQ! Medical devices include a wide range of products described in Directive 93/42/EEC (MDD) or in the new Regulation 2017/745 (MDR).

#72. Understanding the European Directive 93/42/EEC for Medical ...

In-house workshop reviewing the articles of the European Directive 93/42/EEC for medical devices & applying risk evaluation & risk control principles.

#73. 93/42 EEC Guide Informational Training |

The purpose of this training is to clarify the requirements of the 93/42 EEC Certification Medical Device Directive and share information on ...

#74. Post-market Clinical Follow-up (PMCF) GAP Analysis for ...

The passage from the MDD 93/42/CEE to the MDR 2017/745 remains a big challenge for the manufactures. The interpretation of the regulatory requirements stays ...

#75. STATEMENT TRANSITION FROM THE MDD 93/42/EEC ...

PREMISE. The new European Regulation 745/2017 (MDR) officially became effective on 26 May 2021, replacing the Directive 93/42 / EEC (MDD) on Medical Devices ...

#76. Medical Device Directives - the Association of British ...

The Medical Devices Directive (93/42/EEC) classifies products according to their level of risk. Manufacturers must make sure they comply with all the ...

#77. MDD醫療設備指令輔導及稽核發證 - 歐盟CE認證

醫療器械指令（Medical Devices Directive，93/42/EEC），適用範圍很廣，包括除有源植入性和體外診斷器械之外的幾乎所有的醫療器械，如無源性醫療器械（敷料、一次性使用 ...

#78. Declaration of Conformity According to Medical Device ...

According to Medical Device Directive (MDD) 93/42/EEC. We declare under our sole responsibility that the products, to which this declaration relates,.

#79. EN 455 part 1,2,3 and 4: Directive 93/42/EEC ... - Reflexx

EN 455 part 1,2,3 and 4: Directive 93/42 / EEC on medical devices (MDD 93/42), Published on Official Gazette of the Community in June 1993.

#80. European Medical Device Directive - Essential Requirements ...

Essential Requirements – Annex I, 93/42/EEC as amended by Directive 2007/47/EC. I. GENERAL REQUIREMENTS. 1. The devices must be designed and manufactured in.

#81. How to Obtain a CE Mark for Medical Device - Decomplix

Directive concerning medical devices 93/42/EEC (MDD). But the directives have already reached their expiration date: In May 2017, the new ...

#82. LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC ...

LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 93/42/EEC Medical devices. Name and address of the notified bodies.

#83. The MDD 93/42/EEC: Buy Devine Guidance for Complying ...

Devine Guidance for Complying with the European Medical Device Directive (MDD) - The MDD 93/42/EEC by Devine Christopher Joseph Dr, PhD from Flipkart.com.

#84. Medical Device Directive 93/42/EEC Archives - Orcanos

Orcanos G2 Badges · Categories · Popular Tags · Our Address · Products · Company · Resources.

#85. EU MDD 93/42/EEC - IET Digital Library

... (2) Council Directive 93/42/EEC on Medical Devices (1993) [8]; and (3) Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998) ...

#86. 2006-2 Certificates issued by Notified Bodies with reference to ...

Certificates issued by Notified Bodies with reference to the Council Directives 93/42/EEC on medical devices (MDD), 98/79/EC on in vitro diagnostic medical ...

#87. How are medical devices regulated in the European Union?

Medical Device Directive (MDD 93/42/EEC);. In Vitro Diagnostic Medical Device Directive (IVDMDD 98/79/EC).

#88. The New List Of Harmonised Standards For Medical Devices

The harmonised standards for medical devices drafted in support of Directive 93/42/EEC and listed in Annexes I and II to this Decision may not be used to ...

#89. Column - MDD – Annex VII - MedTech Intelligence

Annex VII (EC Declaration of Conformity) of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) is all about the ...

#90. 歐盟醫療器材法規重大更新，衝擊醫材廠商布局

MDR 法規將取代醫療器材指令（Medical Device Directive, MDD, 93/42/EEC）和主動植入式醫療器材指令（Active Implantable Medical Device Directive, ...

#91. MDD 93/42/EEC - 微珂医药技术服务（上海）有限公司

MDD 93/42 /EEC. 医疗器械Medical Devices Directive，指令名： 医疗器械的1993年6月14日理事会指令93/42/EEC，适用范围： 医疗器械和它们的附件。

#92. 集賢生技醫療器材法規顧問公司

我們提供醫療器材上市許可證申請，以符合歐盟醫療器材法規MDD IVDD IVDR、美國醫療 ... 醫療器材指令(Medical Device Directive, 93/42/EEC )(Directive 2007/47/EC ...

#93. MDD – Medical Devices Directive - mdi Europa

The Medical Devices Directive 93/42/EEC (MDD) gives manufacturers the opportunity to develop their own compliance program. We guide you through the entire ...

#94. 93/42/EEC Archives - Medical Device Academy

There were several updates to the MEDDEVs released as supporting documents for the M5 version of the MDD (93/42/EEC as modified by ...

#95. Medical Devices Directive 93/42/EEC (MDD) - Kiwa

Read here more about the Medical Devices Directive 93/42/EEC (MDD), which was taken effect in 1993, revised in 2010 and is replaced by the MDR in 2021.

#96. Medical Devices 93/42 / EEC – CE Mark MDD - EUROCERT

Medizinprod93 / 42 / EWG – CE certification for medical devices MDD. Council Directive 93/42 / EEC of June 14, 1993 on medical devices is ...

#97. 93/42/EEC (2007) Medical Device Directive - CEpartner4U

93/42 /EEC (2007) Medical Device Directive ; 1993-42-EEC-MDD EN-2007.pdf, Download ...

#98. 2_1_3_rev_3-12_2009_en.pdf - MEDDEV.info

The demarcation between the Medical Devices Directive 93/42/EEC (MDD)3 and the Active Implantable Medical Device Directive 90/385/EEC (AIMDD)4 on the one ...