Acceptance Mark
20130422 Safety Information
The European Commission announced in September 2012 that the medical device regulatory law

will be revised legislative framework for medical devices has put forward two proposals. One of

Medical Devices Regulations proposal would replace the Medical Device Directive (MDD 93/42/EEC)

Another proposal for in vitro diagnostic use with the Active Implantable Medical Device Directive

(AIMDD 90/385/EEC); medical Devices Regulations, as an alternative to the original in vitro diagnostic

devices Directive (IVDD 98/79/EC). The two proposals has been officially submitted to the

European Commission and the Council, may be approved in 2014, the new law is expected to take

in 2015-2019.

This amendment will have the legislative and regulatory framework of the EU medical equipment for

large-scale changes, the three Medical Device Directive two regulations will be changed to a

comprehensive and integrated
EU legislation and regulation of medical devices. The proposal will

the MDD and AIMDD two instruction integrate a new Medical Devices Regulations be amended to

all medical devices and active implantable medical devices In addition to the in vitro diagnostic

medical devices
, originally belonging to the two directives regulatory.