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Central Management Committee


Central Management Committee - CMC - What is this?

CMC consist of Competent Authorities and someone referred to it as an "Association of Competent Authorities".  It is not known what the CMC really is.  Please refer to their own "Rules of Procedures" which can be found here:  http://www.cmc-md.eu/mediapool/97/978504/data/cmc-rules-of-procedure-v1-endorsed-in-liage-belgium-september-22nd-2010.pdf

This is a very interesting development in the European Union.  It seems that the Competent Authorities wish for a strong central agency without allowing other stakeholder to participate.  With scanning the website we were not able to identify where the mandate is being derived from.  We need to keep in mind that administration should be implemented with some democratic backing.  This organization was simply formed by member states administration.  It should be questioned on how the mandate now is being given to the CMC in each country.  This again is highly political.  The consequences are difficult for medical devices manufacturer since the CMC has started to issue opinions or interpretations concerning the European regulation.  Someone may welcome clear instructions but should consider that most likely the most severe interpretation will be provided. 

A very simple example is that an opinion was issued that the address of the manufacturer and of the AR should be provided in the most severe format.  Details can found here: http://www.cmc-md.eu/mediapool/97/978504/data/Decision_3_COEN-1.pdf

This is in particular interesting because the European harmonized standard EN 1041 which provides the assumption for conformity allows to abbreviate the address.  Furthermore, it is interesting that the Competent Authorities are welcome to work in standard committees as well as does have procedures in place to correct or change standard.  In addition the European Commission provides for regular exchange at various levels for all stakeholders involved and also provides a forum for Competent Authority exchange without third party involvement.  So what is not working now in Europe that a new club needed to be opened? 

Please note that the first rumors were distributed that the Swedish Competent authority now is enforcing these labeling requirement.  We recommend to evaluate the need to update yours and the MDSS address to be in compliance to the new CMC requirement.

Conclusion on the CMC:

The directive or national laws are binding and not the CMC decision or for that matter any other guidance documents.  However, in the court of law it may have some weight since now it presents itself as unambiguous pan European authority decision to a court.  The other aspect to consider is that the CMC may be in the position if organized in a certain way to receive the European mandate for the central agency which is currently being discussed with the recast of the directives.

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