最新欧盟医疗器械法规目录

Guidance MEDDEVs

The guidelines aim at promoting a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives, and by the Competent Authorities charged with safeguarding Public Health.

They have been carefully drafted through a process of consultation with various interested parties during which intermediate drafts were circulated and comments were taken up in the documents. Therefore, they reflect positions taken in particular by representatives ofCompetent Authorities and Commission Services, Notified Bodies, industry and other interested parties in the medical devices sector.

The guidelines are not legally binding. It is recognised that under given circumstances, for example, as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements.

Due to the participation of the aforementioned interested parties and of experts from Competent Authorities, it is anticipated that the guidelines will be followed within the Member States and, therefore, ensure uniform application of relevant Directive provisions. Guidelines are subject of a regular updating process.

Disclaimer : Please note that the amendments introduced by Directive 2007/47/EC or previous amending directives have not yet been incorporated in all MEDDEVs. The necessary revision is under way.

2.1

Scope, field of application, definition

TITLE

MEDDEV 2.1/1(19 KB) Definitions of \\April 1994

MEDDEV 2.1/2 rev.2(14 KB) Field of application of directive \medical devices\April 1994

MEDDEV 2.1/2.1(12 KB) Field of

application of directive \medical devices\February 1998

MEDDEV 2.1/3 rev.3(182

KB) Borderline products, drug-delivery products and medical devices

incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative December 2009

MEDDEV 2.1/4(21 KB) 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

For the relation between the MDD and directive 89/686/EEC concerning personal protective

equipment, please see the Commission services interpretative document of 21 August 2009(32 KB)

MEDDEV 2.1/5(10 KB) Medical devices with a measuring function June 1998

MEDDEV 2.1/6(323 KB) Qualification and Classification of stand alone software January 2012

2.2

Essential requirements

MEDDEV 2.2/1 rev.1February 1998 MEDDEV 2.2/3 rev.3June 1998

(16 KB) EMC requirements

(17 KB)\

MEDDEV 2.2/4(39 KB) Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products

January 2012

MEDDEV 2.4/1 rev.9(654 KB) Classification of medical devices June 2010

2.4

Classification of MD 2.5

Conformity assessment procedure

General rules

Quality assurance.

Regulatory auditing of quality systems of medical device manufacturers

(See document in the GHTF-Global Harmonization Task Force) MEDDEV 2.5/3 rev.2related June 1998

MEDDEV 2.5/5 rev.3February 1998

(9 KB) Subcontracting quality systems

(7 KB) Translation procedure

MEDDEV 2.5/6 rev.1(10 KB) Homogenous batches (verification of manufacturers' products) February 1998

Conformity assessment for particular groups of products MEDDEV 2.5/7 rev.1implants July 1998

(93 KB) Conformity assessment of breast

Evaluation of medical devices incorporating products of animal origin. (See MEDDEV 2.11/1 rev.2(82 KB))

MEDDEV 2.5/9 rev.1(97 KB) Evaluation of medical devices incorporating products containing natural rubber latex February 2004 MEDDEV 2.5/10 Representatives January 2012

(78 KB) Guideline for Authorised

2.7

Clinical

investigation, clinical evaluation

MEDDEV 2.7/1 rev.3(378 KB) Clinical evaluation: Guide for manufacturers and notified bodies December 2009

Appendix 1: Clinical evaluation on coronary stents(101 KB) December 2008

MEDDEV 2.7/2(37 KB) Guide for Competent Authorities in making an assessment of clinical investigation notification December 2008 MEDDEV 2.7/3

(166 KB) Clinical investigations: serious

adverse event reporting - SAE reporting formDecember 2010

(87 KB)

MEDDEV 2.7/4(180 KB) Guidelines on Clinical

investigations: a guide for manufacturers and notified bodies December 2010

MEDDEV 2.10/2 rev.1(105 KB) Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices

Annex 1(120 KB), Annex 2(14 KB), Annex 3(17 KB), Annex 4(26 KB) April 2001

MEDDEV 2.12/1 rev.8(745 KB) Medical Devices Vigilance System

January 2013 Manufacturer Incident Report(971 KB) How to use the MIR(13 KB)

Field Safety Corrective Action(2 MB) Trend Report(151 KB)

Periodic Summary Report(192 KB) MIR and FSCA xml files (2 MB) List of contact points

2.10 Notified bodies

2.12 Market surveillance

MEDDEV 2.12/2 rev.2 Follow-up studies January 2012

(221 KB) Post Market Clinical

2.13

Transitional period

MEDDEV 2.13 rev.1(13 KB) 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(36 KB)

MEDDEV 2.14/1 rev.2(75 KB) Borderline and Classification issues. A guide for manufacturers and notified bodies January 2012 MEDDEV 2.14/2 rev.1February 2004

(64 KB) Research Use Only products

2.14 IVD

MEDDEV 2.14/3 rev.1(80 KB) Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD)Medical Devices

January 2007

Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device

Directive, Article 10(213 KB) January 2007

MEDDEV 2.14/4(115 KB) CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP January 2012

MEDDEV 2.15 rev.3(33 KB) Committees/Working Groups contributing to the implementation of the Medical Device Directives

December 2008

2.15 Other guidances

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