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April 24, 2024 at 10:05 AM. By Philip Blenkinsop and Ingrid Melander. BRUSSELS (Reuters) -The European Commission launched a probe into China's public procurement of medical devices on Wednesday ...
April 15, 2024 at 5:14 AM. (Reuters) -The European Union is set to launch an investigation into China's procurement of medical devices to address concerns that Beijing's policies are unfairly ...
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 ...
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. Consumers and health professionals report ...
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as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
21 U.S.C. ch. 9, subch. VIII § 381. The Medical Device Regulation Act or Medical Device Amendments of 1976 was introduced by the 94th Congress of the United States. Congressman Paul G. Rogers and Senator Edward M. Kennedy were the chairperson sponsors of the medical device amendments.
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