The legislation on medical devices states that the manufacturer, or his authorized representative, is obliged to notify the Ministry of Health, if they become aware of any deterioration in the characteristics and performance of a device or any inadequacy in the instructions for use which might lead to or that have led to death or serious deterioration in the health of a patient or user, as well as safety reasons that led to the withdrawal from the market of a medical device by the manufacturer itself.
The reporting obligations also apply to the 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.
The medical devices vigilance unit of Di Renzo Regulatory Affairs is part of a broader monitoring unit which also covers the area of medicinal products for human and veterinary use (pharmacovigilance), biocides, cosmetics and food supplements.
Di Renzo Regulatory Affairs is able to offer its clients the following services:
- The role of Responsible person for vigilance Italy
- The role of Responsible person for vigilance at a European level and point of contact with the competent authorities of the various countries, having experienced partners in this sector in all EU Member States and in many non-European countries
- Assistance to manufacturers with the requirements provided for by European regulations relating to incidents in EU and non-EU territory (Management of notifications of incidents / near misses)
- Assistance to manufacturer / authorized representative during the follow-up of incidents and near misses
- Updates on national and European legislation
- Refresher courses for company staff
- Preparation of company standard operating procedures (SOP) for device-vigilance activities.