This Regulation also applies to clinical investigations conducted in the Union concerning the products referred to in the first subparagraph.ģ. Notwithstanding Article 122, Member States' measures regarding the qualification of the products covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall remain valid until the date of application, as referred to in the first subparagraph, of the relevant common specifications for that group of products. They shall apply as from six months after the date of their entry into force or from ►M1 ◄, whichever is the latest. The necessary common specifications shall be adopted by ►M1 ◄. The common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation regarding safety. This Regulation shall also apply, as from the date of application of common specifications adopted pursuant to Article 9, to the groups of products without an intended medical purpose that are listed in Annex XVI, taking into account the state of the art, and in particular existing harmonised standards for analogous devices with a medical purpose, based on similar technology. 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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