On 5 April 2017 the European Parliament and council on medical devices published Regulation (EU) 2017/745 (MDR) concerning the clinical investigation and sale of medical devices for human use.
This regulation was set as an amendment to Directive 2011/83/EEC, regulation (EC) no 178/2002 and regulation (EC) no 1223/2009 and repealing council directives 90/385/EEC and 93/42/EEC.
Regulation 2017/746 contains the regulations that must be followed when in vitro medical devices are put on the market and placed into service.
Link to Regulation (EU) 2017/745 (MDR)
EU Regulation 2017/746 (IVDR) on in-vitro diagnostic medical devices was also published on the 5 April 2017, repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
Link to Regulation (EU) 2017/746 (IVDR)
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