Genotoxicity assessment of medical devices
If chemical analytical testing and the toxicological risk assessment fails to demonstrate that leachables of a medical device are associated with an acceptable risk for genotoxicity, genotoxicity tests are required to assess the potential presence of toxins that can impact the genetic material of cells. Since no single test can detect all genotoxins, the standard for medical device genotoxicity testing […]
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 […]
In vitro assessment of respiratory toxicity: selection of a suitable cell line
With the human lung having more than 60 different cell types and a variety of different cell functions present, the in vitro assessment of respiratory toxicity is a challenging endeavor. Each cell type and the function it performs represents a potential target for a toxic mechanism of action. The first question when selecting a suitable […]
In vitro alternatives for skin sensitization testing of medical devices
Besides cytotoxicity and irritation, sensitization is one of the three biological endpoints that must be evaluated for all medical devices independent of type and duration of their body contact (ISO 10993-1). In contrast to irritation (ISO 10993-23) and cytotoxicity (ISO 10993-5), validated in vitro methods that are qualified and well established in routine use are still lacking […]
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 […]
Update of ISO standard for toxicological risk assessment of medical device constituents
Toxicological Risk Assessment; International standard. The International standards organization (ISO) has updated its ISO 10993-17 standard, that describes the process and requirements for the toxicological risk assessment of medical device constituents. After more than 20 years, the standard replaces the previous version from 2002, introducing various changes. The new revision is more extensive than the previous edition […]
Regulatory framework: Release of FDA Guidance for Use of International Standard ISO 10993-1
FDA has updated their guidance document on ISO 10993-1 to assist industry in preparing regulatory submissions. It incorporates several considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in […]