Europe

EUROPE

Medical Devices
Medical Device Directive 93/42/EEC
Active Implantable Medical Device Directive 90/385/EC
In Vitro Diagnostic Directive 98/79/EC
Latest revision of the Medical Device Directive, Active Implantable Device Directive and Biocidal Directive 2007/47/EC

Medicinal Products
Good Clinical Practice Directive 2005/28/EC
Directive on Medicinal Products 2001/83/EC
Clinical Trial Directive 2001/20/EC

GUIDELINES
MEDDEV

Classification of a Medical Device Part 1
Classification of a Medical Device Part 2
Medical Device Vigilance System
Interface with other directives - medical devices/medicinal products
Evaluation of medical devices incorporating products of animal origin
Evaluation of medical device incorporating natural rubber latex

EC Guidelines

EC Guidance document for the implementation of the 2007/47/EC directive

IVD
Borderline issues