Date : April 05, 2017
Author : Europe
Goal/scope : To ensure the proper functioning of the internal market for medical devices, based on a high level of health protection for patients and users, and taking into account small and medium-sized enterprises that are active in this sector.
At the same time, to set high standards for the quality and safety of medical devices in order to address common safety issues related to these products.
Date : April 05, 2017
Author : Europe
Objectif/scope : To ensure the proper functioning of the internal market for in vitro diagnostic medical devices, based on a high level of health protection for patients and users, and taking into account small and medium-sized enterprises that are active in this sector.
At the same time, to set high standards for the quality and safety of in vitro diagnostic medical devices in order to address common safety issues related to these products.
Date : November 26, 2021
Author : Europe
Goal/scope : Modalities of application of Regulation (EU) 2017/745 of the European Parliament and of the Council with regard to the European database on medical devices (Eudamed).
Date : December 14, 2021
Author : Europe
Goal/scope : Modalities of application of Regulation (EU) 2017/745 of the European Parliament and of the Council with regard to electronic instructions for use of medical devices.
Date : August 08, 2012
Ahor : Europe
Goal/scope : Specific requirements concerning the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC for active implantable medical devices and medical devices manufactured using animal tissues.
Date : April 27, 2016
Author : Europe
Goal/scope : Protection of individuals with regard to the processing of personal data and on the free movement of such data (This regulation is not specifically related to the CE marking of medical devices – IVDMDs, but the storage and processing of data related to patients and/or users may be a regulatory issue).
Date : 2022
Author : France
Goal/scope :
Legal provisions concerning Medical Devices and materials vigilance: articles L.5211-1 to 6 and L.5212-1 to 3.
Regulatory provisions concerning Medical Devices and materials vigilance: articles R.5211-1 to R.5211-71 and R.5212-1 to 43.
Date : April 5, 2017
Author : France
Goal/scope :
Legal provisions concerning In Vitro Diagnostic Medical Devices and vigilance: articles L.5221-2 to 8 and L5222-2 to L5222-4.
Date : 1964
Auteur : World Medical Association
Goal/scope : Ethical principles applicable to biomedical research involving human subjects.
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