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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
MEDDEV 2.1/1
Definitions of “medical devices”, “accessory” and “manufacturer”, April 1994
“醫療器材”、“附件”及“製造商”的定義
MEDDEV 2.1/2 rev.2
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
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
邊界產品、傳遞藥物產品及醫療器材的合併物
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
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
MEDDEV 2.1/5
Medical devices with a measuring function, June 1998
有測量功能之醫療器材
MEDDEV 2.1/6
Qualification and Classification of standalone software, July 2016
軟體需求
2.2 Essential requirements 基本要求
MEDDEV 2.2/1 rev.1
EMC requirements, February 1998
EMC電磁相容性要求
MEDDEV 2.2/3 rev.3
“Use by”-date, June 1998
使用期限
MEDDEV 2.2/4
Conformity assessment of In 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
MEDDEV 2.4/1 rev.9
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
MEDDEV 2.5/3 rev.2
Subcontracting quality systems related, June 1998
相關之轉包契約品質系統
MEDDEV 2.5/5 rev.3
Translation procedure, February 1998
翻譯流程
MEDDEV 2.5/6 rev.1
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
MEDDEV 2.5/7 rev.1
Conformity assessment of breast implants, July 1998
乳房植入物一致性評估
MEDDEV 2.5/9 rev.1
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
MEDDEV 2.5/10
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
MEDDEV 2.7/1 rev. 4
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
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
臨床研究指示：給合格當權者之導引
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
臨床研究：嚴重不利事件報告
MEDDEV 2.7/4
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
MEDDEV 2.12/1 rev.8
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
MEDDEV 2.12/2 rev.2
Post Market Clinical Follow-up studies, January 2012
上市後臨床追蹤報告
2.13 Transitional period 過渡期
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 體外診斷醫療器材
MEDDEV 2.14/1 rev.2
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
MEDDEV 2.14/2 rev.1
Research Use Only products, February 2004
研究專用之產品
MEDDEV 2.14/3 rev.1
Supply of instructions for use (IFU) and other information for in-vitro diagnostic (IVD) medical devices, January 2007
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
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 guidance 其他指引
MEDDEV 2.15 rev.3
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
