Toxicology & Applied Science

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Toxicology & Applied Science

Toxicology & Applied Science

Category: Medical device regulation (MDR)

The EU Medical Device Regulation (MDR) 2017/745, mandates safety and performance standards for medical device companies to protect public health. The regulation established requirements for quality management systems, clinical evaluations, risk management, and post-market surveillance, often involving notified bodies and requiring a CE marking for devices to be sold in the EU market.

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 […]