Dec 19, 2011

As 2011 winds down, we write you with some final news for the year from the European Union. In addition to several minor points of interest, we offer our recommendations for best practices in handling the, as of yet, unresolved change to labeling requirements.

CMC Decision on Labeling Continued

As reported previously, the Central Management Committee (CMC) on Medical Devices issued a decision on labeling that seemingly conflicts with the European Norm harmonized standard EN 1041:2008.

A polite row ensued with some pushback from CEN/CENELEC and other parties challenging the authority of the CMC to issue such decisions that seemingly undermine one of the corner stones of the EU system in the harmonized standards. The issue is far from closed, but it appears that CEN will acquiesce to the CMC decision (which may result in an amendment to EN 1041:2008), and several competent authorities have already posted the CMC new labeling requirements.

Although the ultimate outcome of this situation has yet to be resolved, our initial recommendation as a best practice: manufacturers comply with the CMC’s labeling requirements. We are available to discuss this further if necessary.

The proposed CMC effective-date of the labeling requirement is September 1, 2012. Details on the requirements are discussed in our August newsletter.

EC Translation Resource

Most manufacturers doing business in the EU are well aware of the need for translation; whether it be IFUs, labeling, or other documents -- translations are a fact of life in the EU business environment. We have recently identified a valuable resource on EU languages, available on the European Commission website.

Although, the information is primarily directed towards translators, there is useful content for anyone dealing with a multi-lingual environment. Manufacturers may also wish to provide the resource to their translators.

Croatia Advances towards EU Membership

The European Commission recently announced the finalization of accession negotiations with Croatia. This paves the way for Croatia’s accession to the EU as the 28th member, with a tentative date of July 1, 2013.

Croatia has transposed the Medical Devices Directive into national law through the Medical Devices Act, of 2008 (Official Gazette No. 67/08) and Ordinance on Essential Requirements, Classification, Quality System, Entry into the Register of Manufacturers and Med. Devices and Assessment of Conformity of Medical Devices (Official Gazette No. 43/10). The Competent Authority, HALMED, is responsible for medical device regulations.

French Competent Authority to Be Renamed

A Bill before the French Parliament aimed at modernizing the healthcare system, would result in a reorganization and renaming of the French Competent Authority, Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps), to L'Agence Nationale de Sécurité du Médicament et des Produits de santé (ANSM).


  • Stewart Eisenhart