Sterilizers and the medical device directive.
There are a number of important issues currently facing the European Commission on the interpretation and implementation of the Medical Device Directive (MDD).  One of these concerns medical device sterilizers used in hospitals, physicians' or dentists' offices, or other medical settings, and whether they should be regulated under the MDD.  Any decision made on this issue could have important implications on future decisions of whether or not to include a product under the European medical device regulatory scheme.  For this reason, the medical device industry in general, not only manufacturers of sterilizers, should be aware of this issue.  The industry should also understand the implications of the resulting policies that may be developed.  This article will point out some of the factors that could influence the European decision-making process.  It will also provide information on the regulatory approach that the US Food and Drug Administration (FDA) has taken towards sterilizers.
Donawa
M E
ME
Donawa and Associates Ltd., Rome, Italy.
D005060:Europe; D006801:Humans; D013242:Sterilization / Q000295:instrumentation / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration