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MEDDEV guidance

Guidance Documents

Guidance Documents

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MEDDEV guidance

List of all the MEDDEVs, the European Commission's official guidance for Medical Devices. This European guidelines are useful for Medical Device manufacturers, Notified Bodies and Competent Authorities.

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MEDDEV 2.1 Scope, field of application, definition

MEDDEV 2.1/1 Definitions of Medical Devices, Accessory and Manufacturer April 1994 Download (19 KB) »

MEDDEV 2.1/2 rev.2 Field of Application of Directive Active Implantable Medical Devices April 1994 Download (14 KB) »

MEDDEV 2.1/2.1 Treatment of Computers used to program Implantable Pulse Generators February 1998 Download (12 KB) »

MEDDEV 2.1/3 rev.3 Borderline products, Drug-delivery products and Ancillary Medicinal Substance or 2009 Download (180 KB) »

MEDDEV 2.1/4 Interface with other directives EMC, PPE and Medical Devices Directive March 1994 Download (21 KB) »

MEDDEV 2.1/5 Medical devices with a Measuring Function June 1998 Download (10 KB) »

MEDDEV 2.1/6 Qualification and Classification of Standalone Software July 2016 Download (463 KB) »

MEDDEV 2.2 Essential Requirements

MEDDEV 2.2/1 rev.1 EMC requirement February 1998 Download (16 KB) »

MEDDEV 2.2/3 rev.3 "Use-by" date June 1998 Download (17 KB) »

MEDDEV 2.2/4 Conformity assessment of IVF and Assisted Reproduction Technologies (ART) January 2012 Download (39 KB) »

MEDDEV 2.4 Classification of Medical Devices

MEDDEV 2.4/1 rev. 9 Classification of Medical Devices June 2010 Download (428 KB) »

MEDDEV 2.5 Conformity Assessment Procedure

MEDDEV 2.5/3 rev.2 Subcontracting - Quality systems related June 1998 Download (9 KB) »

MEDDEV 2.5/5 rev.3 Translation procedure February 1998 Download (7 KB) »

MEDDEV 2.5/6 rev.1 Homogenous batches February 1998 Download (10 KB) »

MEDDEV 2.5/7 rev.1 Conformity assessment of breast implants July 1998 Download (93 KB) »

MEDDEV 2.5/9 rev.1 Evaluation of MDs incorporating products containing natural rubber latex February 2004 Download (97 KB) »

MEDDEV 2.5/10 Guideline for Authorized Representative January 2012 Download (75 KB) »

MEDDEV 2.7 Clinical investigation and clinical evaluation

MEDDEV 2.7/1 rev.4 Clinical evaluation - Guide for manufacturers and notified bodies June 2016 Download (519 KB) »

MEDDEV 2.7.1 Appendix 1 Clinical evaluation of Coronary Stents December 2008 Download (101 KB) »

MEDDEV 2.7/2 rev.2 Guide for CAs for making an assessment of clinical investigation application September 2015 Download (409 KB) »

MEDDEV 2.7/3 rev. 3 Clinical investigations - serious adverse event reporting May 2015 Download (354 KB) »

MEDDEV 2.7/3 SAE Report Table v2 Excel Download (28 KB) »

MEDDEV 2.7/4 Guidelines on clinical investigations - a guide for manufacturers and notified bodies December 2010 Download (66 KB) »

MEDDEV 2.10 Notified Bodies

MEDDEV 2.10/2 rev.1 Designation and monitoring of notified bodies April 2001 Download (76 KB) »

MEDDEV 2.10/2 rev.1 Annex 1 Qualification of personnel April 2001 - German version Download (120 KB) »

MEDDEV 2.10/2 rev.1 Annex 2 Program April 2001 Download (14 KB) »

MEDDEV 2.10/2 rev.1 Annex 3 UK Medical Device Notified Body Group - Responsibilities of NBs April 2001 Download (17 KB) »

MEDDEV 2.10/2 rev.1 Annex 4 Rules of Accreditation for Certification Bodies of Quality Systems April 2001 Download (26 KB) »

MEDDEV 2.12 Market Surveillance

MEDDEV 2.12/1 rev.8 Medical devices vigilance system January 2013 Download (745 KB) »

MEDDEV 2.12/1 How to use the MIR form? March 2011 Download (13 KB) »

MEDDEV 2.12/1 Report form: Manufacturer's Incident Report December 2012 Download (971 KB) »

MEDDEV 2.12/1 Report Form: Field Safety Corrective Action December 2012 Download (1,35 MB) »

MEDDEV 2.12/1 Field Safety Notice Template Word Download (107 KB) »

MEDDEV 2.12/1 FAQ to fill in Field Safety Notice Download (135 KB) »

MEDDEV 2.12/1 Field Safety Notice - Distributors/Importers reply form Download (59 KB) »

MEDDEV 2.12/1 Field Safety Notice - Customers reply form Download (80 KB) »

MEDDEV 2.12/1 rev.7 Periodic Summary Report form March 2012 Download (195 KB) »

MEDDEV 2.12/1 rev.7 Trend report form March 2012 Download (166 KB) »

MEDDEV 2.12/1 Manufacturer Incident Report: MDR/IVDR (Serious Incidents) & (AI)MDD/IVDD (Incidents) Download (178 KB) »

MEDDEV 2.12/1 How to use the new Manufacturer Incident Report (MIR) form Download (129 KB) »

MEDDEV 2.12/2 rev.2 Clinical evaluation - Post market clinical follow-up January 2012 Download (221 KB) »

MEDDEV 2.13 Transitional period

MEDDEV 2.13/1 rev.1 Commission communication on the application of transitional provision April 1998 Download (13 KB) »

MEDDEV 2.13/1 Interpretative document of the commission's services June 2009 Download (37 KB) »

MEDDEV 2.14 In Vitro Diagnostic Medical Devices

MEDDEV 2.14/1 rev.2 Borderline and Classification issues January 2012 Download (75 KB) »

MEDDEV 2.14/2 rev.1 Research use only products February 2004 Download (64 KB) »

MEDDEV 2.14/3 rev.1 Supply of Instructions for Use and other information for IVD January 2007 Download (80 KB) »

MEDDEV 2.14/4 CE marking of blood based IVD for vCJD based on detection of abnormal PrP January 2012 Download (115 KB) »

MEDDEV 2.15 Other guidances

MEDDEV 2.15 rev.3 Committees/Working groups contributing to the implementation of the MDD December 2008 Download (33 KB) »

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