Forward
Immediately inform the manufacturer about complaints and reports of suspected incidents it receives.
Your EU Authorised Representative & PRRC for MDR/IVDR medical devices
The manufacturer reports serious incidents and field safety corrective actions. The EU Authorised Representative makes sure information reaches the manufacturer and cooperates with authorities on corrective action.
| Situation | Report no later than |
|---|---|
| Serious incident (general rule) | 15 days after the manufacturer becomes aware of it |
| Death or unanticipated serious deterioration in a person's state of health | 10 days after awareness |
| Serious public health threat | 2 days after awareness |
The manufacturer reports immediately after establishing a causal relationship, or its reasonable possibility, and at the latest within these deadlines.
Immediately inform the manufacturer about complaints and reports of suspected incidents it receives.
Cooperate with competent authorities on preventive or corrective action to eliminate or mitigate risks.
Give authorities the documentation they request, and forward requests for samples or access to the manufacturer.
Terminate the mandate and inform the authority if the manufacturer acts contrary to its obligations.
Agree in advance how complaints reach you from the Authorised Representative, distributors and users, who drafts field safety notices, and how translations are handled. Field safety notices must be in an official Union language determined by the Member State where the action is taken.
The manufacturer reports. The Authorised Representative forwards complaints and reports it receives and cooperates with authorities on corrective action.
No later than 15 days after awareness; 10 days for death or unanticipated serious deterioration in health; 2 days for a serious public health threat.
Yes, into an official Union language determined by the Member State where the field safety corrective action is taken.
The tasks behind these duties.
The PRRC's role in vigilance.
EAR and PRRC packages.
Note: This guide provides general information about Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), not legal advice. Specific obligations depend on your device and company structure. Last reviewed 30 September 2026.
Tell us your device type, class and where your company is established. We will qualify the next step before any mandate is signed.