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Congratulations! After years of hard work we have achieved that two of our female urinary incontinence families (Female Remeex System and Contasure Needleless) are approved under the MDR regulation.


What is the MDR?
It is the new European Medical Device Regulation that defines the regulations and obligations that all manufacturers and distributors must comply with in order to market a medical device in the European market. This regulation, in addition to integrating the previous Directives 90/385/EEC and 93/42/EEC, establishes stricter requirements and measures, in line with the evolution of the medical device market worldwide.

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