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This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.Ģ. This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union.

REGULATION (EU) 2020/561 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 23 April 2020Ĭorrigendum, OJ L 334,, p. On medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL Those official texts are directly accessible through the links embedded in this document The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. The Union's institutions do not assume any liability for its contents. This text is meant purely as a documentation tool and has no legal effect.

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