In May 2017 two new Regulations on medical devices were published in the EU Official Journal. The two new regulations were adopted in April and replace two existing directives. The two new regulations and links are below:

1) 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

2) 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

Link to the Official Journal publication: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2017:117:TOC