Hi all,
I was hoping to get some guidance regarding the labelling requirements for devices/ articles which contain CMRs or substances with endocrine-disrupting (ED) properties. I understand that where there is a concentration above 0.1% w/w, a reference to these substances must be made on the labeling and IFU. There is however an additional requirement surrounding vulnerable patients (see text in red below).
Annex I - Chapter I, Section 10.4.5.
Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances. If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.
Does anyone know whether the additional information for vulnerable patients is required for devices containing ANY amount of CMRs or substances with ED or is it only needed when above the 0.1% w/w threshold.
Any guidance would be very appreciated
I was hoping to get some guidance regarding the labelling requirements for devices/ articles which contain CMRs or substances with endocrine-disrupting (ED) properties. I understand that where there is a concentration above 0.1% w/w, a reference to these substances must be made on the labeling and IFU. There is however an additional requirement surrounding vulnerable patients (see text in red below).
Annex I - Chapter I, Section 10.4.5.
Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances. If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.
Does anyone know whether the additional information for vulnerable patients is required for devices containing ANY amount of CMRs or substances with ED or is it only needed when above the 0.1% w/w threshold.
Any guidance would be very appreciated