COCIR* and the medical device industry welcome many of the changes proposed in the RoHS recast, particularly the decision not to include any additional substances without proper assessment and scientific studies being done, the extension of the exemption period for medical devices to seven years and the exclusion of large scale industrial tools and large scale fixed installations. Therefore COCIR can support adoption of the compromise text by the European Parliament in their next plenary session.
However, COCIR would like to focus attention on certain points which could negatively impact patient care in the European Union. While COCIR supports the addition of exemptions specific to medical devices, further exemptions will be needed according to the most recent technical independent assessment carried out by Cobham Technical Services. These include but are not limited to RoHS substances in components of medical devices which are critical for the reliability and safety of medical devices where no adequate substitutes are available today.
Without timely acceptance of these exemptions, state of the art technologies and innovations to provide better and earlier diagnosis, and even new treatments may no longer be available to patients within the EU after 2014.
In the context of healthcare spending constraints and in the spirit of recycling economy, CE marked refurbished equipment originating from outside Europe would no longer be available to the European market which will prevent affordability of newer technology for hospitals having limited budgets.
COCIR Secretary General Nicole Denjoy said “We call on the European Commission to expedite the input to ensure there is not a negative impact on healthcare. The industry’s ability to develop innovative new products for patient care and support the EU’s goal of healthy ageing will be severely impacted. We need to ensure that we can provide sustainable technical advances to benefit the health of our society”.
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Kathryn Sheridan
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