Devices using human tissue proposed for Class III status under EU device amendments.
This article was originally published in The Gray Sheet
EU DIRECTIVE AMENDMENT WOULD PUT DEVICES USING HUMAN TISSUE IN CLASS III, the most stringent regulatory category under the European Union's medical device system. According to a proposal recently released by the Commission of the European Communities, the EU's Medical Device Directive (MDD) would be amended to so that "all devices manufactured utilizing human tissues or substances derived from such tissues are in Class III." The proposed amendments to the MDD directive -- the regulatory program for the vast majority of medical devices -- are noted in the latest version of the pending directive on in vitro medical devices.
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