At the request of the Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) prepared the Guidelines to address the new justification requirement set out in the MDR. Companies placing medical devices containing MDR/ED phthalates (or other CMR/ED substances) on the EU market under the MDR should consider how the justification requirement for the use of CMR/ED phthalates could affect their products and operations. The Guidelines may well trigger significant additional work for these companies, including the adoption of measures to avoid supply interruptions.
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