In silico assessment of developmental and reproductive toxicity
Chemicals leaching from medical devices are toxicologically not always fully characterized. Supplementary approaches are therefore needed to allow for a detailed hazard assessment. In this article the use of in silico toxicology to identify and quantify the developmental and reproductive toxicity (DART) potential of substances is investigated. Reproductive toxicity represents the harmful effects of chemical exposure on […]
Regulatory framework for identification and characterization of endocrine disrupters
For decades, studies of endocrine disrupters (EDs) have challenged traditional concepts in toxicology, in particular the dogma “the dose makes the poison” as they can have effects at low doses that are not predicted by effects at higher doses. At the beginning of the 90s the term endocrine disruption first appeared in scientific literature and a workshop […]
Upcoming universal restriction of Per- and polyfluoroalkyl substances (PFAS) in EU and EEA
The main concern related to per- and polyfluoroalkyl substances (PFAS) is their environmental persistence. If release continues the abundance in the environment and hence exposure to organisms including humans will increase. The EU Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) have provisionally concluded on four sectors. The planed universal restriction aims to […]
Potential of alkyl glycol ethers to cause endocrine disruption
An endocrine disruptor is defined as “an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations” (WHO/PCS, 2002). In recent years publications have appeared that mention individual glycol ethers or glycol ethers in general amongst those substances with […]
REACH and MDR hazardous substances
REACH is the abbreviation for ‘Registration, Evaluation and Authorization of Chemicals’. It is an EU regulation that requires manufacturers and importers to register all chemicals produced or imported in significant quantities in the European community. If the portfolio of a medical devices manufacturer includes an article with an identified hazardous substance above the 0.1% (w/w) […]
QMS: Entanglement of biological safety and hazardous substance assessments
The compliance of medical devices with hazardous substance regulations and ensuring their biological safety are entangled tasks. At Medical Matters, biological safety and hazardous substance assessments are therefore strongly interlinked. If the portfolio of a medical devices manufacturer includes an article with an identified hazardous substance above the 0.1% (w/w) MDR limit, regulatory obligations get […]