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Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...
Studierfenster (StudierFenster) is a free, non-commercial Open Science client/server-based Medical Imaging Processing (MIP) online framework. [ 52 ] Medical open network for AI is a framework for Deep learning in healthcare imaging that is open-source available under the Apache Licence and supported by the community.
Certified reference materials (CRMs) are 'controls' or standards used to check the quality and metrological traceability of products, to validate analytical measurement methods, or for the calibration of instruments. [1] A certified reference material is a particular form of measurement standard.
The Measuring Instruments Directive 2014/32/EU, formerly 2004/22/EC, is a directive by the European Union, which seeks to harmonise many aspects of legal metrology across all member states of the EU. [1] Its most prominent tenet is that all kinds of meters which receive a MID approval may be used in all countries across the EU.
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
Medical devices are apparati used for diagnostics, treatment, or prevention of disease and injury. [10] [11] Most of the time these devices affect the structure or function of the body. The easiest way to tell the difference is that biomedical instruments measure, sense, and output data while medical devices do not. Examples of medical devices: