新的法规号码是EU 2017/745 for MDR 和 EU 2017/746 for IVDR.
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
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
新颁布的法规是由指令(Directive)升级为法规(Regulation),提高了文件的约束力
MDR将有源植入器械(现行的90/385/EEC)纳入了进来,与一般医疗器械(现行93/42/EEC)合二为一,IVDR直接取代现行的98/79/EEC
MDR过渡期为3年, 2020年5月4日起强制实行
IVDR过渡期为5年,2022年5月4日起强制实行