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English: These Regulations contain the legislative measures necessary for the implementation of three European Community Directives- Council Directive 90-385-EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93-42-EEC concerning medical devices, as amended; and Directive 98-79-EC of the European Parliament ...
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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).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 device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
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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 EUCAST guidelines are freely available to all of their users. Like the Clinical and Laboratory Standards Institute , EUCAST offers guidelines to interpret raw minimum inhibitory concentrations (MICs), the lowest concentration of a chemical, usually a drug, which prevents visible growth of bacterium.
Design History File (DHF) The sub-clause 4.2.3 of ISO 13485 :2016 requires a manufacturer of medical device to establish a Technical file , similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation .
Medical Device Regulation ("MDR") — Regulation (EU) 2017/745 [5] — and in vitro diagnostic Medical Device Regulation — Regulation (EU) 2017/746 [6] — increase obligations of E.A.R in the field of surveillance of medical devices. [5]