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.

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The new regulation has been published on Official Journal of the European Union (L 117/1) on May 5, 2017.

The new rules apply three years after publication date for medical devices and five years after publication for IVDs.

The new regulations – which cover not only the design and manufacture of devices, but also clinical testing, authorization and post-market surveillance – have an impact on just about every device manufacturer that sells products in the EU.