Can any one guide me on how to market a Class IIb medical device in France.
A determination and explanation for what Medical Device Regulations(s) apply
to gaining approval to market the device in the EU and, if applicable, what sections may or may not be applicable in France.
type of clinical evaluation and study design that will
be required to market the device in France.
An estimate of the time required to obtain marketing approval for France once design of the device is frozen.
An estimate of the cost(s) involved in submitting the regulatory filing fee(s) themselves (i.e. one would include the cost of submission to the Competent Authority in France). You do not need to estimate or include the cost(s)
involved in a potential clinical evaluation.
potential obstacles. These may originate from either the MDR's themselves or Competent Authority related issues.
other EU Member State (s) in which the medical device may be distributed with minimal additional effort on your company's part, given the regulatory strategy you propose.