CE MARKING

NBER has experts in all three EU medical device directives; Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostics.

We can provide assistance and advice with:
		Defining the appropriate CE Marking route
		Technical File development
		Quality Management Systems
		Choice of Notified Body

DIRECTIVE 2005/50/EC

Effective from 1st September 2007, with a transition period for existing devices up to 1st September 2009 (or 2010 if already approved under Annexes VI/III), this directive reclassifies hip, knee and shoulder joint replacement implants as Class III devices. NBER can advise and help with preparation for this transition.

DIRECTIVE 2007/47/EC

The revision of the medical devices directive puts a greater emphasis on clinical data to support the use of devices. NBER can provide help in meeting the requirements through systematic reviews of clinical and scientific literature.