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Abstract：
By the new Medical Device Regulation (MDR, EU 2017/745) the use of certain phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties, above 0.1% by weight (w/w) is only allowed after a proper justification. The SCHEER provide Guidelines on the benefit-risk assessment (BRA) of the presence of such phthalates in certain medical devices. The Guidelines describe the methodology on how to perform a BRA for the justification of the presence of CMR/ED phthalates in medical devices and/or or parts or materials used therein at percentages above 0.1% w/w. They also describe the evaluation of possible alternatives for these phthalates used in medical devices, including alternative materials, designs or medical treatments. Relevant stakeholders e.g. manufacturers, notified bodies and regulatory bodies, can use the guidelines. The approach of these guidelines may also be used for a BRA of other CMR/ED substances present in medical devices. SCHEER noticed that a number of BRA methodologies are theoretically available. However, there is a considerable lack of data needed for the BRA for potential relevant alternatives to be used in medical devices. Therefore, SCHEER encourages manufacturers to generate data of high quality on such alternatives for CMR/ED phthalates in medical devices.
摘要：
根据新的医疗器械法规(MDR,EU2017/745）使用某些致癌的邻苯二甲酸酯，诱变，对生殖有毒(CMR)或具有内分泌干扰(ED)特性，超过0.1%重量(w/w)只允许在适当的理由。SCHEER提供了有关某些医疗设备中存在此类邻苯二甲酸酯的获益-风险评估（BRA）的指南。该指南描述了如何进行BRA的方法，以证明医疗设备和/或其中使用的零件或材料中存在的CMR/ED邻苯二甲酸酯的百分比高于0.1％w/w。他们还描述了用于医疗设备的这些邻苯二甲酸酯的可能替代品的评估，包括替代材料，设计或医疗。相关利益相关者，例如制造商，通知机构和监管机构，可以使用指南。这些指南的方法也可以用于医疗设备中存在的其他CMR/ED物质的BRA。SCHEER注意到许多BRA方法在理论上是可用的。然而,BRA在医疗设备中使用的潜在相关替代品所需的数据相当缺乏.因此,SCHEER鼓励制造商为医疗设备中的CMR/ED邻苯二甲酸酯的此类替代品生成高质量数据。
