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.
Sidley Austin LLP provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship.
Attorney Advertising - For purposes of compliance with New York State Bar rules, our headquarters are Sidley Austin LLP, 787 Seventh Avenue, New York, NY 10019, 212.839.5300; One South Dearborn, Chicago, IL 60603, 312.853.7000; and 1501 K Street, N.W., Washington, D.C. 20005, 202.736.8000.