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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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Directive EU 2017/745 Repealed The Medical Device Directive — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices —is intended to harmonise the laws relating to medical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 .
Download as PDF; Printable version ... Medical device regulation may refer to: Regulation (EU) 2017/745 in the European Union ... Medical Device Regulation Act of ...
Substance-based medical devices encompass a varied array of products that fall under the purview of Regulation (EU) 2017/745 (MDR). Based on their intended purpose, they are classified according to rule 21 ("Devices composed of substances that are introduced via a body orifice or applied to the skin") of Annex VIII of the MDR .
The 2021 addendum to ISO 14971 (ISO 14971:2019+A11:2021) was published to harmonize ISO 14971 and two European Regulations associated with medical devices through the two 'Zed' Annexes (ZA & ZB). The Annex ZA harmonized ISO 14971 with the European Union's Medical Device Regulation (2017/745) of 2017. [11]
Regulation (EU) 2017/745; Regulation (EU) 2017/746; Regulation (EU) 2019/1020; Regulation (EU) 2023/988; Regulation (EU) No 1169/2011; Regulation of ESG rating in the European Union; Regulation of pesticides in the European Union; Regulation on Wholesale Energy Market Integrity and Transparency; Regulation to Prevent and Combat Child Sexual ...
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Council Regulation 1638/98 made changes to the organisation of the olive oil market in the EU. [5] See Unión de Pequeños Agricultores; Council Regulation (EC) 2679/98 of 7 December 1998, on the functioning of the internal market in relation to the free movement of goods among the Member States, was aimed at preventing obstacles to the free movement of goods attributable to "action or ...