Medtech

Medical Device Vigilance, or materiovigilance, involves monitoring incidents from medical device use to enhance patient safety by preventing incident recurrence.

Manufacturers must maintain a vigilant system to ensure incident reporting and compliance based on the relevant regulation for each CE mark, especially for devices combined with pharmaceuticals, meeting both drug and device regulatory standards.

RPN offers vigilance services for all classes of Medical Devices according to the European Medical Devices Regulation (MDR), including:

• Preparation of customized Standard Operating Procedures (SOPs) for a Medical Device Vigilance system and their maintenance over time.
• Incident analysis in order to determine whether they are reportable or if a corrective action may be reportable as a field safety correction action (FSCA).
• Expedited reporting of incidents: preparation and submission of Manufacturer Incident Reports (MIR) and Field Safety Notices (FSN) to competent authorities where necessary.