National Member States Regulators (CMC members) decided on a harmonised way to label manufacturer address on products and instructions for use. Those Competent Authorities are requesting that all manufacturers implement this decision no later than September 2012, reason why COCIR calls for particular attention of manufacturers and distributors putting medical devices on European market.

The MDD 93/42/EEC Essential Requirements state that the manufacturer has to place his name and address on the product label and in the instruction for use. It is to achieve a common interpretation of this requirement that the Central Management Committee (CMC) issued a decision requesting manufacturers and authorised representatives to provide their address in a harmonised way.

COCIR sent a letter to the CMC Chair and COEN Chair on 14 May raising our concern regarding the process that preceded this decision. The CMC Decision No. 3 was released and published without any prior involvement of relevant stakeholders. COCIR invited the CMC in future cases to be more transparent upfront and to discuss with the key stakeholders before releasing any decision in order to reach a common view on optimum implementation aspects. COCIR also welcomes the draft COEN guideline of 12 February 2012 on “Implementation of the CMC Decision N° 3” which is particularly useful and brings some clarification on the implementation of this Decision.