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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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Directive EU 2017/745 Repealed The Medical Device Directive — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices —is intended to harmonise the laws relating to medical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 .
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.
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October 2017) (Learn how and when to remove this message) 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 ...
Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (Text with EEA relevance) Image title: Author: www.legislation.gov.uk: Software used: FOP 1.0 ...
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]
mdr is the ISO 639 language code for the Mandar language; M. D. Ramanathan (1923–1984), Indian singer known as MDR; Mandatory declassification review, part of the process of removing the classification of a document; Medical Device Regulation (EU2017/745), a 2017 European Union regulation covering medical devices