The Crystal Ball While not mentioned recently, it is fully expected that the EU IVD regulation wi

The Crystal Ball

While not mentioned recently, it is fully expected that the EU IVD regulation will implement a classification system similar to that suggested by the GHTF and promulgated by the Australian IVD regulations. The majority of respondents to the IVD directive public questionnaire were in favor of a risk-based rules classification system. Of course, it also is unspoken that one outcome of the revision will be the demise of some Notified Bodies. The EU Commission has notunequivocally stated that the revision will involve medical device regulations—it certainly appears that this will be the result.

Lastly, the ultimate prognostication—the estimated date the regulations become enforceable—would seem at the earliest to be 2015.

As we conclude the year, we wish our readers a joyous and happy holiday season. We fully expect the events of 2012 to keep this column entertaining.

Reference:

1. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2011:202:0007:0009:EN:PDF