+32(0)14 49 04 22

MEDDEV guidance

Guidance Documents

Guidance Documents

Library

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.

If you want to receive document updates and other regulatory news immediately in your mailbox, subscribe to our newsletter!

Other libraries

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) »

Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8 Download (862 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) »

Don't hesitate to contact us if you need help with the interpretation with one of these documents!

QARAD B.V.B.A.

Headquarters
Pas 257, 2440 Geel
BELGIUM
Tel.: +32 (0)14 49 04 22
Mail.: info@qarad.com

ISO 13485 Certified

Follow us on:

Quicklinks

Website by Analyz-it • Contents by Qarad • Terms and conditions • Privacy policy • Cookie policy •

Close

Attention!

This website uses cookies to enhance your surfing experience.
Certain webfunctions rely on the usage of these cookies.
If you want more information regarding our cookie policy, you may visit this link.