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MHRA Publishes Guidance Relating to DEHP Phthalates in Medical Devices

28 September 2015

Focus on Regulation – Hogan Lovells Blog

On 10 September 2015, the Medicines and Healthcare Products Regulatory Agency (“MHRA”) published guidance in relation to medical devices which contain polyvinyl chloride (“PVC”) plastic with Di(2-ethylhexyl) phthalate (hereafter “DEHP phthalates”). The MHRA guidance would appear to be inspired by the publication of a report issued on 25 June 2015 by the European Commission which provides detailed discussion on the issue of DEHP phthalates in medical devices.

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