De Jong, W.H. and Borges, T. and Ion, R.M. and Panagiotakos , D. and Testai, E. and Vermeire, T. and Scott, M. and Samaras, T. and Proykova, A. and Kraetke, R. and Hoet, P. and Bertollini, R. and Duarte-Davidson, R. and Slama, R. and de Voogt, P. and Kraetke, R. and Proykova, A. and Vighi, M. (2020) Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties. Regulatory Toxicology and pharmacology, 111. p. 104546.
Full text not available from this repository.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.
| Item Type: | Article |
|---|---|
| Subjects: | Q Science > Q Science (General) Q Science > QP Physiology R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine R Medicine > RS Pharmacy and materia medica |
| Depositing User: | Marco Vighi |
| Date Deposited: | 18 Feb 2020 09:04 |
| Last Modified: | 15 Jun 2023 15:15 |
| URI: | http://eprints.imdea-agua.org:13000/id/eprint/1144 |
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