Brussels, 10 July 2009. Eucomed has today issued a recommendation to its members to promote a harmonised and sensible approach to the new labelling requirement for medical devices that contain phthalates such as DEHP, a commonly used plasticizer in PVC.
The new requirement as outlined in Eucomed’s recommendation comes into force on 21 March 2010 and only affects a certain specific group of medical devices. The requirement affects manufacturers of particular fluid administration, transport or storage type devices who use phthalates such as DEHP, in their devices. The European Standards Organisation, CEN, is currently developing a symbol to help meet the requirement.
“We are concerned that the standard under development by CEN will not be available in time and cost implications in terms of revised labelling and logistics could potentially be counted in millions of Euros,” says John Wilkinson, Chief Executive of Eucomed. “Therefore, we have put together a recommendation for affected companies to allow sufficient time to revise their labelling and logistics process in line with the new requirement”, he concluded.
Eucomed is the Voice of the medical technology industry in Europe. Eucomed represents directly and indirectly 4500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry invests some €5.8 billion in R&D and employs near to 530,000 highly skilled workers. The mission of Eucomed is to improve patient and clinician access to modern, innovative and reliable medical technology.
Mark Grossien
Director Communications and External Affairs
mark.grossien(at)eucomed(dot)be
+32 (0)2.775.92.24
