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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.
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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).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 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]
Directive EU 2017/745 Repealed The Medical Device Directive — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices —is intended to harmonise the laws relating to medical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 .
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Commission Implementing Regulation (EU) 2017/764 of 2 May 2017 approving non-minor amendments to the specification for a name entered in the register of traditional specialities guaranteed (Ovčí hrudkový syr — salašnícky (TSG)) Image title: Author: www.legislation.gov.uk: Software used: FOP 1.0: Conversion program: Apache FOP Version 2.1 ...
Commission Delegated Regulation (EU) 2017-1946 of 11 July 2017 supplementing Directives 2004-39-EC and 2014-65-EU of the European Parliament and of the Council with regard to regulatory technical standards for an exhaustive list of information to be included by proposed acquirers in the notification of a proposed acquisition of a qualifying holding in an investment firm (Text with EEA relevance)
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