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Vigilanza Dispositivi Medici

Medical Device Vigilance

Based on Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), manufacturers have the obligation of reporting any serious incident involving one (or more) of their medical devices as well as any safety corrective action taken to the relevant competent authorities.

This obligation also applies to legal representatives of public and private healthcare facilities as well as public and private healthcare professionals, on the basis of findings in the course of their activities.

Di Renzo Regulatory Affairs experts assist their clients with the following services:

  • assumption of the role of vigilance responsible person in Europe or Local Contact Point in Italy (also on behalf of authorised representatives and/or distributors)
  • management of the incident reports to the Competent Authorities
  • advice during the investigation and preparation of corrective actions (FSCA)

Foto di Bruno /Germany da Pixabay