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#Industry News

MDR REGULATION

The MDR (Medical Device Regulation), or EU Regulation 2017/745

he MDR (Medical Device Regulation), or EU Regulation 2017/745, is a fundamental European regulation for medical devices. It came into force in May 2021 and replaced the previous directives (MDD and AIMDD) to ensure greater safety and patient health protection through more stringent requirements, more rigorous surveillance, in-depth technical documentation, and greater product traceability. Fisiopress is pursuing this certification soon.

Details

  • Via Mori, 6, 40054 Prunaro BO, Italy
  • Francesco Offidani