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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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Additionally, the EU member state accrediting the notified body will then inform the European Commission that the product complies with the essential requirements (or not). [1] [2] [3] More generally, a notified body is an independent, accredited body which is entitled by an authorized accrediting body. Upon definition of standards and ...
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as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...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 ...
European Union (EU) concepts, acronyms, and jargon are a terminology set that has developed as a form of shorthand, to quickly express a (formal) EU process, an (informal) institutional working practice, or an EU body, function or decision, and which is commonly understood among EU officials or external people who regularly deal with EU institutions.
BRUSSELS (Reuters) -The European Commission launched a probe into China's public procurement of medical devices on Wednesday, the latest in a series of moves that ratchet up trade tensions ahead ...
The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information ...
Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market. Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.