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Meddevs

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