Medical Device Directives
MDD 93/42/EEC (Medical Device Directive) has been in place since June 14, 1998 and was amended on September 5, 2007. The consolidated directive became mandatory on March 21, 2010. The directive establishes essential requirements and harmonized standards for the manufacture, design, and packaging of medical devices.
Read more: MDD 93/42/EEC – Medical Device Directive
REGULATION (EU) 2017/745
Medical Devices Regulation
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.
Read more: MDR 2017/745 – Medical Device Regulation
REGULATION (EU) 2017/746
In-Vitro Diagnostic Device Regulation