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Manual on borderline and classification in the community regulatory framework for medical devices
Guidance document - Market surveillance - Guidelines on a Medical Devices Vigilance System - MEDDEV 2.12/1 rev.8
Guidance document - Market surveillance - Guidelines on a Medical Devices Vigilance System - MEDDEV 2.12/1 rev.8
Guidance document - In vitro diagnostic medical devices - CE marking of blood based in vitro diagnostic medical devices for variant Creutzfeldt-Jakob Disease (vCJD) based on detection of abnormal PrP (host protein) - MEDDEV 2.14/4
Guidance document Medical Devices - Conformity assessment procedure - Guideline for Authorised Representatives - MEDDEV 2.5/10
Guidance document - In vitro diagnostic medical devices - Borderline and Classification issues. A guide for manufacturers and notified bodies - MEDDEV 2.14/1 rev.2
Guidance document Medical Devices - Essential requirements - Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products - MEDDEV 2.2/4
Guidance document Medical Devices - Scope, field of application, definition - Qualification and Classification of stand alone software - MEDDEV 2.1/6
Guidance document Medical devices - Market surveillance - Post Market Clinical Follow-up studies - MEDDEV 2.12/2 rev.2
Manual of Decisions for Implementation of Directive 98/8/EC concerning the placing on the market of biocidal products
Information on the Customs Union Agreement with Turkey in the field of medical devices
Guidance document - Clinical investigation, clinical evaluation - Clinical investigations: serious adverse event reporting - MEDDEV 2.7/3
Guidance document Medical Devices - Clinical investigation, clinical evaluation - Guidelines on Clinical investigations: a guide for manufacturers and notified bodies - MEDDEV 2.7/4
Informative document of the Commission’s services on placing on the market of medical devices
Guidance document - Classification of Medical Devices - MEDDEV 2.4/1 rev.9
Guidance document - Clinical investigation, clinical evaluation - Clinical evaluation: Guide for manufacturers and notified bodies - MEDDEV 2.7/1 rev.3
Guidance document - Scope, field of application, definition - Borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative - MEDDEV 2.1/3 rev.3
Information on the relation between the revised Directives 90/385/EEC and 93/42/EEC concerning (active implantable) medical devices and Directive 2006/42/EC on machinery
Information on the relation between the revised Directive 93/42/EEC concerning medical devices and Directive 89/686/EEC on personal protective equipment
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