Mecatheque
Results of collective works
Comparison between the Machinery Directive (MD) and the Medical Devices Directive (DDM)
Personal aid equipment is governed by the Machinery Directive 2006/42/EC (MD) and the Medical Device Directive 93/42/EEC (MDD). Further to the request issued by the Medical devices and medical technologies commission, Cetim performed a regulatory and normative comparison between these two directives (in the form of a commented table) in order to identify all identical (or equivalent) obligations and all specific obligations. The aim is to define a unique and simplified procedure covering the specifications of both directives. An example is given, which integrates the IDAR methodology method developed by Cetim.