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2013-04-22
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
Medical 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
effect 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
cover all medical devices and active implantable medical devices In addition to the in vitro diagnostic
medical devices, originally belonging to the two directives regulatory.
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
Medical 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
effect 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
cover all medical devices and active implantable medical devices In addition to the in vitro diagnostic
medical devices, originally belonging to the two directives regulatory.
