Navigation path

Guidance document - Committees/Working Groups contributing to the implementation of the Medical Device Directives - MEDDEV 2.15 rev.3
Workshop on reprocessing of medical devices (Brussels, 5 December 2008)
Guidance document Medical Devices - Clinical investigation, clinical evaluation - Guide for Competent Authorities in making an assessment of clinical investigation notification - MEDDEV 2.7/2
Outcome of the first public consultation on the reprocessing of medical devices
Recast of the medical devices directives - public consultation
Information on the Medical Devices Directives in relation to medical device own brand labellers
Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive, Article 10
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 on Directive 2005/50/EC on the reclassification of hip, knee and shoulder joint replacements
Guidance document on the demarcation between the cosmetic products Directive 76/768 and the medicinal products Directive 2001/83 as agreed between the commission services and the competent authorities of Member States
Public Consultation on a proposal for a Directive of the European Parliament and of the Council amending Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
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
Guidance document - Essential requirements - “Use by”-date - MEDDEV 2.2/3 rev.3
Guidance document - Conformity assessment procedure - Subcontracting quality systems related - MEDDEV 2.5/3 rev.2
Guidance document - Field of application of directive “active implantable medical devices” - Treatment of computers used to program implantable pulse generators - MEDDEV 2.1/2.1
Guidance document - Essential requirements - Electromagnetic Compatibility (EMC) requirements - MEDDEV 2.2/1 rev.1
Guidance document - Conformity assessment procedure - Translation procedure - MEDDEV 2.5/5 rev.3
Guidance document - Conformity assessment procedure - Homogenous batches (verification of manufacturers' products) - MEDDEV 2.5/6 rev.1
Guidance document - Definitions of “medical devices”, “accessory” and “manufacturer” - MEDDEV 2.1/1
Guidance document - Field of application of directive “active implantable medical devices” - MEDDEV 2.1/2 rev.2
Guidance document - Interface with other directives – Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective equipment - MEDDEV 2.1/4
Results per page: 5 10 15 20 25 | Page 11 out of 11

Additional tools