In January 2014, during the MDEG meeting, a report from COEN was presented. One topic was the presentation of the outcome of joint market surveillance activities on dental and bone fillers.
A COEN meeting was held on 12 February 2014 and a few FIDE member companies have attended the meeting in order to discuss the measures to improve the identified observations.
On March 14th, FIDE sent a statement concerning the market surveillance on dental fillers to the Commission (Working Group COEN). The paper was worked out in collaboration with the
Association of the European Self Medication Industry (AESGP) and the German Association BAH.
Additionally, we sent the "FIDE Statement on the risk classification of medical devices containing nanomaterial on the basis of an assessment of their health effects“ issued in September 2012 as a
reaction to the proposed requirements regarding medical devices containing nanomaterials as part of the amendment of European medical device legislation (new classification rule 19) , and as
well to SCENIHR’s request for a scientific opinion on the safety of medical devices containing nanomaterials.
FIDE Statement Market Surveillance dental fillers 2014-03-14.pdf
FIDE Statement nano and recast Sept2012final.pdf