CE医疗器械相关法规
发布人： 发布时间：2016-10-25 点击：872次
医疗器材指令修订版：Directive 2007/47/EC
相关文件：
(1) Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (AIMD)主动植入式医疗器材 , 2007
(2) Directive 93/42/EEC concerning medical devices (MDD)医疗器材指令 , 2007
(3) Directive 98/79/EC on in vitro diagnostic medical devices (IVDD)体外诊断医疗器材 , 2003
(4) COM(2005) 535 Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment.
Guidelines relating to medical devices Directives:
2.1 Scope, field of application, definition 范围、申请领域、定义
MEDDEV 2.1/1Definitions of “medical devices”, “accessory” and “manufacturer”, April 1994
“医疗器材”、”附件”及”製造商”定义
MEDDEV 2.1/2 rev.2 Field of application of directive “active implantable medical devices”, February 1998
“主动植入式医疗器材” 指示申请领域
MEDDEV 2.1/3 rev.3 Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative,December 2009
边界产品、传递药物产品及医疗器材的合併物
MEDDEV 2.1/4 Interface with other directives – Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment, March 1994
与其他指令分界-与电磁相容性相关之医疗器材/指令以及个人防护设备相关
MEDDEV 2.1/5 Medical devices with a measuring function, June 1998
有测量功能之医疗器材
MEDDEV 2.1/6 Qualification and Classification of stand alone software, January 2012
软体需求
2.2 Essential requirements基本要求
MEDDEV 2.2/1 rev.1 EMC requirements, February 1998EMC电磁相容性要求
MEDDEV 2.2/3 rev.3 “Use by”-date, June 1998使用期限
MEDDEV 2.2/4 Conformity assessment of In VitroFertilisation (IVF) and Assisted Reproduction Technologies (ART) products, January 2012
2.4 Classification of MD 医疗器材分类
MEDDEV 2.4/1 rev.9 Classification of medical devices, June 2010
2.5 Conformity assessment procedure一致性评估程序
General rule 基本规范
Quality assurance. Regulatory auditing of quality systems of medical device manufacturers
品质保证：医疗器材製造商之品质系统管理审查
MEDDEV 2.5/3 rev.2 Subcontracting quality systems related, June 1998相关之转包契约品质系统
MEDDEV 2.5/5 rev.3 Translation procedure, February 1998 翻译流程
MEDDEV 2.5/6 rev.1 Homogenous batches (verification of manufacturers' products), February 1998 同质批组
Conformity assessment for particular groups of products 特殊产品类别的一致性评估
MEDDEV 2.5/7 rev.1 Conformity assessment of breast implants, July 1998
乳房植入物一致性评估
MEDDEV 2.5/9 rev.1 Evaluation of medical devices incorporating products containing natural rubber latex, February 2004 与取自动物之混合产品医疗器材评估
MEDDEV 2.5/10 Guideline for Authorised Representatives, January 2012
2.7 Clinical investigation, clinical evaluation临床研究临床评估
MEDDEV 2.7/1 rev.3 Clinical evaluation: Guide for manufacturers and notified bodies, December 2009
Appendix 1: Clinical evaluation on coronary stents, December 2008
临床评估：给製造商与验证单位之导引与附件
MEDDEV 2.7/2 rev. 2 Guidelines for Competent Authorities for making a validation/assessment of a clinical investigation application under directives 90/385/EEC and 93/42/EC, September 2015临床研究指示：给合格当权者之导引
MEDDEV 2.7/3 rev. 3 Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC - SAE reporting form, May 2015
临床研究：严重不利事件报告
MEDDEV 2.7/4 Guidelines on Clinical investigations: a guide for manufacturers and notified bodies, December 2010临床研究导引：给製造商与验证单位之导引
2.12 Market surveillance 市场调查
MEDDEV 2.12/1 rev.8 Guidelines on a Medical Devices Vigilance System, January 2013 医疗器材警觉系统导引
MEDDEV 2.12/2 rev.2 Post Market Clinical Follow-up studies, January 2012 上市后临床追踪报告
2.13 Transitional period 过渡时期
MEDDEV 2.13 rev.1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05), August 1998
As regards the transitional regime of Directive 2007/47/EC see the Interpretative Document of the Commission's services of 5 June 2009
2.14 IVD
MEDDEV 2.14/1 rev.2 Borderline and Classification issues. A guide for manufacturers and notified bodies, January 2012 边界议题
MEDDEV 2.14/2 rev.1 Research Use Only products, February 2004 研究专用之产品
MEDDEV 2.14/3 rev.1 Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD)Medical Devices, January 2007 使用指示提供以及其他IVD医疗器材相关资讯
Form for the registration of manufacturers and devices In Vitro Diagnostic Medical DeviceDirective, Article 10, January 2007 IVD医疗器材的製造商申请格式
MEDDEV 2.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP, January 2012
2.15 Other guidances 其他指引
MEDDEV 2.15 rev.3 Committees/Working Groups contributing to the implementation of the Medical Device Directives, December 2008
相关文件：
(1) Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (AIMD)主动植入式医疗器材 , 2007
(2) Directive 93/42/EEC concerning medical devices (MDD)医疗器材指令 , 2007
(3) Directive 98/79/EC on in vitro diagnostic medical devices (IVDD)体外诊断医疗器材 , 2003
(4) COM(2005) 535 Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment.
Guidelines relating to medical devices Directives:
2.1 Scope, field of application, definition 范围、申请领域、定义
MEDDEV 2.1/1Definitions of “medical devices”, “accessory” and “manufacturer”, April 1994
“医疗器材”、”附件”及”製造商”定义
MEDDEV 2.1/2 rev.2 Field of application of directive “active implantable medical devices”, February 1998
“主动植入式医疗器材” 指示申请领域
MEDDEV 2.1/3 rev.3 Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative,December 2009
边界产品、传递药物产品及医疗器材的合併物
MEDDEV 2.1/4 Interface with other directives – Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment, March 1994
与其他指令分界-与电磁相容性相关之医疗器材/指令以及个人防护设备相关
MEDDEV 2.1/5 Medical devices with a measuring function, June 1998
有测量功能之医疗器材
MEDDEV 2.1/6 Qualification and Classification of stand alone software, January 2012
软体需求
2.2 Essential requirements基本要求
MEDDEV 2.2/1 rev.1 EMC requirements, February 1998EMC电磁相容性要求
MEDDEV 2.2/3 rev.3 “Use by”-date, June 1998使用期限
MEDDEV 2.2/4 Conformity assessment of In VitroFertilisation (IVF) and Assisted Reproduction Technologies (ART) products, January 2012
2.4 Classification of MD 医疗器材分类
MEDDEV 2.4/1 rev.9 Classification of medical devices, June 2010
2.5 Conformity assessment procedure一致性评估程序
General rule 基本规范
Quality assurance. Regulatory auditing of quality systems of medical device manufacturers
品质保证：医疗器材製造商之品质系统管理审查
MEDDEV 2.5/3 rev.2 Subcontracting quality systems related, June 1998相关之转包契约品质系统
MEDDEV 2.5/5 rev.3 Translation procedure, February 1998 翻译流程
MEDDEV 2.5/6 rev.1 Homogenous batches (verification of manufacturers' products), February 1998 同质批组
Conformity assessment for particular groups of products 特殊产品类别的一致性评估
MEDDEV 2.5/7 rev.1 Conformity assessment of breast implants, July 1998
乳房植入物一致性评估
MEDDEV 2.5/9 rev.1 Evaluation of medical devices incorporating products containing natural rubber latex, February 2004 与取自动物之混合产品医疗器材评估
MEDDEV 2.5/10 Guideline for Authorised Representatives, January 2012
2.7 Clinical investigation, clinical evaluation临床研究临床评估
MEDDEV 2.7/1 rev.3 Clinical evaluation: Guide for manufacturers and notified bodies, December 2009
Appendix 1: Clinical evaluation on coronary stents, December 2008
临床评估：给製造商与验证单位之导引与附件
MEDDEV 2.7/2 rev. 2 Guidelines for Competent Authorities for making a validation/assessment of a clinical investigation application under directives 90/385/EEC and 93/42/EC, September 2015临床研究指示：给合格当权者之导引
MEDDEV 2.7/3 rev. 3 Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC - SAE reporting form, May 2015
临床研究：严重不利事件报告
MEDDEV 2.7/4 Guidelines on Clinical investigations: a guide for manufacturers and notified bodies, December 2010临床研究导引：给製造商与验证单位之导引
2.12 Market surveillance 市场调查
MEDDEV 2.12/1 rev.8 Guidelines on a Medical Devices Vigilance System, January 2013 医疗器材警觉系统导引
MEDDEV 2.12/2 rev.2 Post Market Clinical Follow-up studies, January 2012 上市后临床追踪报告
2.13 Transitional period 过渡时期
MEDDEV 2.13 rev.1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05), August 1998
As regards the transitional regime of Directive 2007/47/EC see the Interpretative Document of the Commission's services of 5 June 2009
2.14 IVD
MEDDEV 2.14/1 rev.2 Borderline and Classification issues. A guide for manufacturers and notified bodies, January 2012 边界议题
MEDDEV 2.14/2 rev.1 Research Use Only products, February 2004 研究专用之产品
MEDDEV 2.14/3 rev.1 Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD)Medical Devices, January 2007 使用指示提供以及其他IVD医疗器材相关资讯
Form for the registration of manufacturers and devices In Vitro Diagnostic Medical DeviceDirective, Article 10, January 2007 IVD医疗器材的製造商申请格式
MEDDEV 2.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP, January 2012
2.15 Other guidances 其他指引
MEDDEV 2.15 rev.3 Committees/Working Groups contributing to the implementation of the Medical Device Directives, December 2008