Borderline products - BIOCIDE or Medical Device? -- MEDICA - World Forum for Medicine



Borderline products - BIOCIDE or Medical Device?

On 12 June 2009, the European Commission adopted a proposal for a new regulation, COM(2009)267, which will repeal and replace the current BIOCIDE Directive. The proposed regulation is planned to enter into force on 1 January 2013.

COM(2009)267 will extend the scope of BIOCIDES to also cover articles and materials treated with biocidal products (article 47). According to Eucomed, this will result in new borderline products between biocidal products and medical devices. Although medical devices and their accessories are excluded from the BIOCIDE Directive as well as from the new Regulation, issues may occur concerning treated materials (disinfected) or products containing biocides with the intention to protect from deterioration, for example contact lens care solutions. It might be argued that contact lens care solutions has to comply with article 47 of the Regulation COM(2009)267 as it is a product containing biocides to protect contact lenses (MDD). At the same time the contact lens care solution might be considered as an accessory to a medical device and therefore as excluded from the BIOCIDE Regulation.