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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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
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as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
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 ...
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.
Lux meter for measuring illuminance, i.e. incident luminous flux per unit area; Luminance meter for measuring luminance, i.e. luminous flux per unit area and unit solid angle; Light meter, an instrument used to set photographic exposures. It can be either a lux meter (incident-light meter) or a luminance meter (reflected-light meter), and is ...
A plethysmograph is an instrument for measuring changes in volume within an organ or whole body (usually resulting from fluctuations in the amount of blood or air it contains). The word is derived from the Greek "plethysmos" (increasing, enlarging, becoming full), and "graphein" (to write).
A specialized form of vaginal speculum is the weighted speculum, which consists of a broad half tube which is bent at about a 90 degree angle, with the channel of the tube on the exterior side of the angle. One end of the tube has a roughly spherical metal weight surrounding the channel of the speculum.