As discussed in the inside front cover of this issue of Toxicology and Regulatory News, April 2017 saw the adoption by the European Union of two new regulations on medical devices to improve the quality, safety and reliability across Europe – Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The regulations were published in the Official Journal of the European Union in May 2017, with transitional periods ending in 2020 and 2022 respectively.

European Commission (2017).

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 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. Official Journal of the European Union L117, 1-175. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745&from=EN

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Official Journal of the European Union L117, 176-332. http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746&from=EN

 

The above items were taken from the June 2017 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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