Meddevs
INDEX
2.1 SCOPE, FIELD OF APPLICATION, DEFINITION
2.4 CLASSIFICATION OF MEDICAL DEVICES
2.5 CONFORMITY ASSESSMENT PROCEDURE
2.7 CLINICAL INVESTIGATION AND CLINICAL EVALUATION
2.14 IN VITRO DIAGNOSTIC MEDICAL DEVICES
2.1 SCOPE, FIELD OF APPLICATION, DEFINITION
Definitions of 'medical devices', 'accessory' and 'manufacturer' - April 1994
Field of application of directive 'active implantable medical devices' - April 1994
Treatment of computers used to program implantable pulse generators - February 1998
Borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative - December 2009
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
Medical devices with a measuring function - June 1998
Qualification and classification of stand alone software - July 2016
2.2 ESSENTIAL REQUIREMENTS
EMC requirements - February 1998
'Use by' date - June 1998
Conformity assessment of in vitro fertilisation (IVF) and assisted reproduction technologies (ART) products - January 2012
2.4 CLASSIFICATION OF MEDICAL DEVICES
Classification of Medical Devices - June 2010
2.5 SCOPE, FIELD OF APPLICATION, DEFINITION
Subcontracting quality systems related - June 1998
Translation procedure - February 1998
Homogenous batches (verification of manufacturers' products) - February 1998
Conformity assessment of breast implants - July 1998
Evaluation of medical devices incorporating products containing natural rubber latex - February 2004
Guideline for authorised representatives - January 2012
2.7 CLINICAL INVESTIGATION AND CLINICAL EVALUATION
Clinical evaluation: Guide for manufacturers and notified bodies - June 2016
Clinical evaluation on coronary stents - December 2008
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
Clinical investigations: serious adverse reporting under Directives 90/385/EEC and 93/42/EC - May 2015
Guidelines on clinical investigations: a guide for manufacturers and notified bodies - December 2010
2.10 NOTIFIED BODIES
Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices - April 2001
Guidance on the preparation of a curriculum vitae for a Medical Device Expert (document is written in German and translated to English) - April 2001
Example of a training course format - April 2001
The responsibilities of the Notified Body under the Medical Device Directives Document - April 2001
Special Rules of accreditation for Certification Bodies of Quality Systems (scope “Sterile Medical Devices”) - April 2001
2.12 MARKET SURVEILLANCE
Guidelines on a Medical Devices Vigilance System - January 2013
July 2019
December 2012
Post Market Clinical Follow-up studies - December 2012
2.13 TRANSITIONAL PERIOD
Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05) - August 1998
June 2009
2.14 IN VITRO DIAGNOSTIC MEDICAL DEVICES
Borderline and Classification issues. A guide for manufacturers and notified bodies - January 2012
Research Use Only products - February 2004
Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices - January 2007
CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP - January 2012
2.15 OTHER GUIDANCES
Committees/Working Groups contributing to the implementation of the Medical Device Directives - December 2008