Obelis O.E.A.R.C.

CMC Decision on New Format of “Address of the Manufacturer” on Labels & IFUs

On December 1st 2010, the European Competent Authorities within the Medical Devices sector decided the creation of a Central Management Committee (CMC), aimed at harmonizing national notification procedures.

Because Medical Devices are governed by European Directives, a European law concerning Medical Devices could technically be transposed in 27 different manners, through each national parliament of the 27 EU states. Evidently, each national difference, often lying in details, created a big discrepancy within the EU, creating a waste of time, energy and money when manufacturers needed to notify their product in several European states.

Accordingly, the CMC was created to find practical-orientated solutions, aimed at achieving greater consistency in the interpretation and implementation of its provisions, by improving the decision-making process between each National Competent Authorities.

Very recently, the CMC has decided that from December 1st 2012, the “address of the manufacturer” mentioned on the labels and instruction for use (as required in the Essential Requirements), which is the address of the registered place of business of the legal manufacturer shall include:
» Street/Road,
» Number/House/Floor,
» Postal Code
» City
» State/Region and
» Country

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