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醫療器材指令修訂版：Directive 2007/47/EC
相關文件：
(1) Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (AIMD) 主動植入式醫療器材, 2007
(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) 歐盟新醫療器材法規,2017，於2021年5月26日全面實施
(3) Directive 98/79/EC on in vitro diagnostic medical devices (IVDD)體外診斷醫療器材, 2003
(3)已更新為Regulation (EU) 2017/746 In Vitro Diagnostic Devices Regulations, (IVDR)歐盟體外診斷醫療器材法規,2017，預計於2022年5月26日全面實施
(4) COM(2005) 535 Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment.
Guidelines relating to medical devices Directives 與醫療器材指令相關的指引：
2.1 Scope, field of application, definition 範圍、申請領域、定義
Definitions of “medical devices”, “accessory” and “manufacturer”, April 1994
“醫療器材”、“附件”及“製造商”的定義
Field of application of directive “active implantable medical devices”, April 1994
“主動植入式醫療器材”指示申請領域
Borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative, December 2009
邊界產品、傳遞藥物產品及醫療器材的合併物
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
與其他指令分界-與電磁相容性相關之醫療器材/指令以及個人防護設備相關
Medical devices with a measuring function, June 1998
有測量功能之醫療器材
Qualification and Classification of standalone software, July 2016
軟體需求
2.2 Essential requirements 基本要求
EMC requirements, February 1998
EMC電磁相容性要求
“Use by”-date, June 1998
使用期限
Conformity assessment of In Vitro Fertilization (IVF) and Assisted Reproduction Technologies (ART) products, January 2012
體外受精(IVF)與輔助生殖技術(ART)產品的一致性評估
2.4 Classification of MD 醫療器材分類
Classification of medical devices, June 2010
2.5 Conformity assessment procedure 一致性評估程序
•General rule 基本規範
Quality assurance. Regulatory auditing of quality systems of medical device manufacturers
品質保證：醫療器材製造商之品質系統管理審查
Subcontracting quality systems related, June 1998
相關之轉包契約品質系統
Translation procedure, February 1998
翻譯流程
Homogenous batches (verification of manufacturers' products), February 1998
同質批組
•Conformity assessment for particular groups of products 特殊產品類別的一致性評估
Conformity assessment of breast implants, July 1998
乳房植入物一致性評估
Evaluation of medical devices incorporating products containing natural rubber latex, February 2004
與取自動物之混合產品醫療器材評估
Guideline for Authorised Representatives, January 2012
授權代表指引
2.7 Clinical investigation, clinical evaluation 臨床研究臨床評估
Clinical evaluation: Guide for manufacturers and notified bodies, June 2016
Appendix 1: Clinical evaluation on coronary stents, December 2008
臨床評估：給製造商與驗證單位之導引與附件
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
臨床研究指示：給合格當權者之導引
Clinical investigations: serious adverse reporting under directives 90/385/EEC and 93/42/EC - SAE reporting form, May 2015
臨床研究：嚴重不利事件報告
Guidelines on Clinical investigations: a guide for manufacturers and notified bodies, December 2010
臨床研究導引：給製造商與驗證單位的指引
2.12 Post-Market surveillance 上市後監督
Guidelines on a Medical Devices Vigilance System, January 2013
Additional guidance on MEDDEV 2.12/1 rev.8,July 2019
醫療器材警戒系統指引
Post Market Clinical Follow-up studies, January 2012
上市後臨床追蹤報告
2.13 Transitional period 過渡期
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 體外診斷醫療器材
Borderline and Classification issues. A guide for manufacturers and notified bodies, January 2012
界定與分級議題：給製造商與驗證單位的指引
Research Use Only products, February 2004
研究專用之產品
Supply of instructions for use (IFU) and other information for in-vitro diagnostic (IVD) medical devices, January 2007
提供使用說明以及其他體外診斷醫療器材的資訊
Form for the registration of manufacturers and devices In Vitro Diagnostic Medical DeviceDirective, Article 10, January 2007
體外診斷醫療器材的製造商申請表格
CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP, January 2012
2.15 Other guidance 其他指引
Committees/Working Groups contributing to the implementation of the Medical Device Directives, December 2008
促進醫療器材指令實施的工作小組