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Abbrev. [1]Meaning [1] Latin (or Neo-Latin) origin [1]; a.c. before meals: a.d., ad, AD right ear auris dextra a.m., am, AM morning: ante meridiem: nocte every night ...
Changes compared to the Medical Device Directive include changes in device classification and device scope, stricter oversight of manufacturers by notified bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC) and of the economic operator concept, the requirement of Unique Device Identification marking for devices, EUDAMED registration (see below), UDI requirements ...
At the same time the NB-MED (European Forum of Notified Bodies Medical Devices) coordination revised their code of conduct due to criticism. [7] [15] In late 2013 and early 2014, a French court ordered (and later upheld its decision) that notified body TÜV Rheinland pay restitution to those affected by the PIP scandal. [16]
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
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as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
Device Name Specialty Description External link (if no internal link) Adson's forceps: Alfred Washington Adson: General use: Tissue forceps: Adson-Graefe forceps at Whonamedit? [1] ...
The Final Rule on Unique Device Identifiers also mandates medical device manufacturers to make a submission to the FDA's Global Unique Device Identification Database. The submission to the GUDID will include the Primary Device Identifier portion of the UDI as well as associated data attributes about each model or version number of the device.
The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...