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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
Informative document of the Commission’s services on implementation of directive 2007/47/EC amending directives 90/385/EEC, 93/42/EEC and 98/8/EC
Guidance document - Committees/Working Groups contributing to the implementation of the Medical Device Directives - MEDDEV 2.15 rev.3
Guidance document Medical Devices - Clinical investigation, clinical evaluation - Guide for Competent Authorities in making an assessment of clinical investigation notification - MEDDEV 2.7/2
Information on the Medical Devices Directives in relation to medical device own brand labellers
Guidance document - In vitro diagnostic medical devices - Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices - MEDDEV 2.14/3 rev.1
Guidance document - In vitro diagnostic medical devices - Research Use Only products - MEDDEV 2.14/2 rev.1
Guidance document - Conformity assessment procedure - Evaluation of medical devices incorporating products containing natural rubber latex - MEDDEV 2.5/9 rev.1
Guidance document - Notified bodies - Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices - MEDDEV 2.10/2 rev.1
Guidance document - Conformity assessment procedure - Conformity assessment of breast implants - MEDDEV 2.5/7 rev.1
Guidance document - Medical devices with a measuring function - MEDDEV 2.1/5
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