On 2nd of June 2023 COCIR submitted its first report to the public consultation on the PFAS restriction highlighting the impact of the proposed measure on the medical imaging and radiotherapy sector unless a proper derogation for a minimum of 13,5 years is granted.
COCIR estimates around 10 tonnes per year are used in Europe in medical imaging and radiotherapy devices, almost all in fluoropolymers. 0,0012% of the estimated total usage of PFAS in Eu and 0,02% of the total usage estimated for the medical devices sector in the restriction proposal. Pending some additional data and verification, the usage may be even 10 times lower.
COCIR key concern is that the current proposed restriction will result in a complete halt to sales of critical medical devices in Europe in just a few years. This would have a direct impact on not just the sector, but mostly hospitals and patients in EU. Medical imaging and radiotherapy equipment fall under Regulation (EU) 2017/745 (MDR). Substitution under MDR is a lengthy process due to the complexity of devices and the extensive testing and certification requirements.