Detergents intended to treat medical devices are medical devices according to new EU regulation 2017/745 (MDR) which replaced Directive 93/42. As a result, our OneLife products are classified Class I medical devices. That said, detergents are also subject to 3 other European regulations:1 / EU Regulation N ° 1907/2006 = REACH Regulation on all chemical substances2 / EU Regulation No. 648/2004 = Regulation on detergents3 / Regulation (EC) n ° 1272/2008 = CLP (Classification, Labeling & Packaging) which regulates the marking, packaging and classification (pictograms) of chemicals.

OneLife products meet the requirements of the above mentioned regulations and are therefore compliant.