Meddevs

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

Interface with other directives – Medical devices Directive 89/336/EEC relating to electromagnetic compatibility and Directive 89/686/EEC relating to personal protective equipment - March 1994

MEDDEV 2.1/5

Medical devices with a measuring function - June 1998

MEDDEV 2.1/6

Qualification and classification of stand alone software - July 2016

Return to index

2.2 ESSENTIAL REQUIREMENTS

MEDDEV 2.2/1 rev.1

EMC requirements - February 1998

MEDDEV 2.2/3 rev.3

'Use by' date - June 1998

MEDDEV 2.2/4

Conformity assessment of in vitro fertilisation (IVF) and assisted reproduction technologies (ART) products - January 2012

Return to index

2.4 CLASSIFICATION OF MEDICAL DEVICES

MEDDEV 2.4/1 rev.9

Classification of Medical Devices - June 2010

Return to index

2.5 SCOPE, FIELD OF APPLICATION, DEFINITION

MEDDEV 2.5/3 rev.2

Subcontracting quality systems related - June 1998

MEDDEV 2.5/5 rev.3

Translation procedure - February 1998

MEDDEV 2.5/6 rev.1

Homogenous batches (verification of manufacturers' products) - February 1998

MEDDEV 2.5/7 rev.1

Conformity assessment of breast implants - July 1998

MEDDEV 2.5/9 rev.1

Evaluation of medical devices incorporating products containing natural rubber latex - February 2004

MEDDEV 2.5/10

Guideline for authorised representatives - January 2012

Return to index

2.7 CLINICAL INVESTIGATION AND CLINICAL EVALUATION

MEDDEV 2.7/1 rev.4

Clinical evaluation: Guide for manufacturers and notified bodies - June 2016

MEDDEV 2.7.1 Appendix 1

Clinical evaluation on coronary stents - December 2008

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

MEDDEV 2.7/3 rev.3

Clinical investigations: serious adverse reporting under Directives 90/385/EEC and 93/42/EC - May 2015

MEDDEV 2.7/3 SAE Report Table v2

2.1

2.2

Index

2.4

2.5

2.7

MEDDEV 2.7/4

Guidelines on clinical investigations: a guide for manufacturers and notified bodies - December 2010

Return to index

2.10

2.10 NOTIFIED BODIES

MEDDEV 2.10/2 rev.1

Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices - April 2001

MEDDEV 2.10/2 rev.1 Annex 1

Guidance on the preparation of a curriculum vitae for a Medical Device Expert (document is written in German and translated to English) - April 2001

MEDDEV 2.10/2 rev.1 Annex 2

Example of a training course format - April 2001

MEDDEV 2.10/2 rev.1 Annex 3

The responsibilities of the Notified Body under the Medical Device Directives Document - April 2001

MEDDEV 2.10/2 rev.1 Annex 4

Special Rules of accreditation for Certification Bodies of Quality Systems (scope “Sterile Medical Devices”) - April 2001

Return to index

2.12

2.12 MARKET SURVEILLANCE

MEDDEV 2.12/1 rev.8

Guidelines on a Medical Devices Vigilance System - January 2013

Additional Guidance Regarding the Vigilance System

MEDDEV 2.12/1 rev.8, 2013

July 2019

MEDDEV 2.12/1 Field Safety Corrective Action

December 2012

MEDDEV 2.12/1 Field Safety Notice Template

MEDDEV 2.12/1 Qs and As to fill in the Field Safety Notice

MEDDEV 2.12/1 Field Safety Notice - Customer Reply

MEDDEV 2.12/1 Field Safety Notice - Distributor/Importer

Reply

MEDDEV 2.12/1 Trend Report

MEDDEV 2.12/1 Periodic Summary Report

MEDDEV 2.12/2 rev.2

Post Market Clinical Follow-up studies - December 2012

Return to index

2.13 TRANSITIONAL PERIOD

2.13

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