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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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Directive EU 2017/745 Repealed The Medical Device Directive — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices —is intended to harmonise the laws relating to medical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 .
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 .
Download QR code; Print/export ... Download as PDF; Printable version; In other projects ... Medical device regulation may refer to: Regulation (EU) 2017/745 in the ...
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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Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (Text with EEA relevance) Image title: Author: www.legislation.gov.uk: Software used: FOP 1.0: Conversion program