1 Classification等级 Rule规则 A/NA Description Non-invasive devices非侵略性设备 1.1Rule 1 All non-invasive devices are in Class I,unless one of the rules set out hereinafter applies 所有非侵入性设备在I类,除非下文列出的适用规则之一 1.2Rule 2 All non-invasive devices intended for channeling or ...
Rule11:新添加,提出用于提供诊断或治疗目的决策信息和监测生理过程的软件,均为II a类;其他软件类为I类。 Rule 14-Rule 22:SPECIAL RULES特殊规则 Rule14:进一步完善了“衍生自人体血液或血浆的医疗产品”分类的要求。 Rule 18:进一步完善“利用非活性或处理为非活性的人体或动物源组织或细胞或其他衍生物制成的器械...
文档分类: 待分类 文档标签: ce认证mdd分类导则 系统标签: 认证devicesruleliquidschannelingextracorporeal 16 MEDDEV2.4/1–rev.8PART2:GUIDELINESFORTHECLASSIFICATIONOFMEDICALDEVICES(July2001) ... 4.2GENERALEXPLANATIONOFRULES/PRACTICALISSUES/EXAMPLES Rule1-Devicesthateitherdonottouchthepatientorcontactintactskin...
1 . Devices shall be divided into Classes I, Ila, lib and III. Classification shall be carried out in accordance with Annex IX. 2. In the event of a dispute between the manufacturer and the notified body concerned, resulting from the application of the classification rules, the matter shall...
MEDICAL DEVICES: Guidance document MEDDEV 2.4/1 Rev.8 July 2001 GUIDELINES FOR THE CLASSIFICATION OF MEDICAL DEVICES The present Guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on medical devices. They are legally not binding. The Guidelines ...
Whereas the classification rules generally enable medical devices to be appropriately classified; whereas, in view of the diverse nature of the devices and technological progress in this field, steps must be taken to include amongst the implementing powers conferred on the Commission the decisions to ...
85 – PMS report (class I devices) YES (classification of devices in class I follows classification rules of the MDD, i.e. Art. 85 applies to class I ‘legacy devices’ despite the fact that those devices might be in a higher class under the MDR) Art. 86 – PSUR (class IIa, IIb ...
16MEDDEV.4/1–rev.8PART:GUIDELINESFORTHECLASSIFICATIONOFMEDICALDEVICESJuly001...4.GENERALEXPLANATIONOFRULES/PRACTICALISSUES/EXAMPLESRule1-DevicesthateitherdonottouchthepatientorcontactintactskinonlyGeneralexplanationoftheruleThisisafallback
2、PlaceCountry : Accessories: Date Name Reviewer Signature Reviewer DateName Reviewer Signature Reviewer Checklist according to annex I of the Medical Device Directive (MDD)按医疗器械指令(MDD) 附录一的基本要求检查表A/NA适用/不适用Standards, other directives and other rules applied by manufacturer制造...
MDCG也发布了MDR下医疗器械分类的指南文件:MDCG 2021-24 Guidance on classification of medical devices 对应分类规则如下: 器械类型 MDD MDR NON-INVASIVE DEVICES NVASIVE DEVICES ACTIVE DEVICES SPECIAL RULES Rule 1- Rule 4 Rule 5-Rule 8 Rule 9-Rule 12 Rule 13-Rule 18 Rule 1- Rule 4 Rule 5-Ru...