Periodic Safety Update Report (PSUR)
Periodic Safety Update Report (PSUR) is a collection of pharmacovigilance data that helps competent authorities and NBs in determining the risk-benefit ratio of a medicinal product concerningthe global safety norms.The data collected through these reports help both patients and healthcare professionals in retrieving the necessary updates.
When the Post Market Surveillance Report (PMSR) is added with data regarding devices with higher risk then it gets transformed into a Post Market Surveillance Report (PSUR). For EU, PSUR is needed for Class IIa, IIb and III devices.
Periodic Safety Update Report (PSUR) requirements:
|Class I||PMSR||As Requested||As per Need|
|Class IIa||PSUR||NB Reviewed for Confirmity||Every 2 years|
|Class IIb (Non-Implantable)||PSUR||NB Reviewed for Confirmity||Annually|
|Class IIb (Implantable)||PSUR||EUDAMAD/ NB Reviewed for Conformity||Annually|
|Class III (Implantable)||PSUR||EUDAMAD/ NB Reviewed for Conformity||Annually|
|IVD Class A,B||PMSR||As Requested||As per Need|
|IVD C||PSUR||NB Reviewed for Conformity||Annually|
|IVD D||PSUR||EUDAMAD/ NB Reviewed for Conformity||Annually|
With MakroCare for PSUR
- Get your necessary templates and procedures developed.
- Signal detection setup and review continuously.
- Gather data from different sources (PMS, PMCF, Vigilance, and others) & incorporate in PSUR.
- Evaluation of the risk-benefit ratio, assessment of residual risk concerning the PMS and CAPA as well as design changes.
- Cross-functional teams with deep experience in Safety areas.