Council Directive of June 14, 1993 concerning medical devices   
SEE MDD 93/42/EEC  (full Version of MDD)

The Council Directive of June 20, 1990, on the approximation of the laws of the Member States relating to active implantable medical devices
SEE MDD 90/385/EEC  (full Version of AIMDD)

 

European Commission
Guidance Documents

Guidelines on a Medical Device Vigilance System
MEDDEV 2.12-1 rev 4 April 2001

Guidelines for the Classification of Medical Devices
MEDDEV 2.4/1 rev 8 July 2001

Guidelines on 90/385/EEC April ’94 

Guidelines relating to the application of Council Directive 90/385/EEC on Active Implantable Medical Devices and Council Directive 93/42/EEC on Medical Devices: Definition of "medical devices", Definition of "accessory", Definition of "manufacturer"

Commission Communication – 05 June ’98 - Final Draft

Transitional Period

MEDDEV 2.5/5 Rev.0 – January ’98

Guidelines on assessment of medical devices incorporating materials of animal origin with respect to viruses and transmissible agents

MEDDEV 2.12/1 Rev.3 – February ’98

Guidelines on a Medical Devices Vigilance System

MEDDEV 2.1/3 Rev.5.1 – March ’98

Guidelines relating to the demarcation between Directive 90/385/EEC on Active Implantable Medical Devices, Directive 93/42/EEC on Medical Devices and Directive 65/65/EEC relating to Medicinal Products and Related Directives

MEDDEV 13/93 Rev.1 –

Guidelines relating to the application of Council Directive 90/385/EEC on Active Implantable Medical Devices and Council Directive 93/42/EEC on Medical Devices

MEDDEV 5/93 Rev.2 –

Guidelines relating to the application of Council Directive 90/385/EEC on Active Implantable Medical Devices and Council Directive 93/42/EEC on Medical Devices: Field of Application of Directive 90/385/EEC

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