When is a medical device not a medical device?
December 1st 2007 Some time ago, it was recognised that the Medical Devices Directive (MDD) created many difficulties by eliminating the facility for a Medical Device to be PPE at the same time and the EU Group in Brussels had drafted a clause to eliminate the problem. Hopes were high at a PPE meeting in Brussels that the problem had been solved.
Unfortunately, we were to lean that some perverse politicians, who clearly did not seem to understand the issues involved, decided to tinker with the ideally drafted text and it now appears that we shall be forced to find some form of operational compromise to resolve the matter in the market.
What the new text creates is a recognition that a medical device could be protective and that, if this is so, the basics of the PPE Directive must be taken into account (good so far).
However, in doing this, there are no mechanisms to ensure that the product complies with these basics allowing any PPE manufacturer to enter the market with a medical device (category I) claim protective features without the need for any compliance check, CE Mark the product and sell it as PPE.
Needless to say, the PPE enforcement authorities in EU Member states are extremely concerned about this development and the BSIF suspects that a behind-the-scenes solution will need to be found. I guess it’s a case of ‘watch this space’. More articles from BSIF Enterprise: | 
