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Safety Reports for Devices and IVD

Safety report is a collection of Vigilance data that helps competent authorities and NBs in determining the risk-benefit ratio of a medicinal product concerning the global safety norms. The data collected through these reports help both patients and healthcare professionals in retrieving the necessary updates.

For different countries, based on risk classification, reporting period changes. Coming to the content of these reports, there’s lot of overlap between different countries. So not just doing individual reports, MakroCare has standardized templates that can be used across countries and get synergies well to save time and costs

With MakroCare for Safety reports:

  • Bullet Get your necessary templates and procedures developed
  • Bullet Plan and perform continuous Signal detection
  • Bullet Led by safety physicians, resources are pooled globally to match speed and cost of these reports
  • Bullet We use proprietary Authoring tools to ensure consistency and efficiency
  • Bullet In addition, our teams can also perform Evaluation of the risk-benefit ratio to update in these reports
  • Bullet Cross-functional teams with deep experience in Safety areas

Some Requirements across regions/countries:

EUROPE / EU MDR
Class I PMSR As Requested As per Need
Class IIa PSUR NB Reviewed for Conformity Every 2 years
Class IIb (Non-Implantable) PSUR NB Reviewed for Conformity 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
CANADA
Class I Summary Report Not Required Not Required
Class II Summary Report Health Canada Every 2 years
Class III Summary Report Health Canada Annually
Class IV Summary Report Health Canada Annually
IVD Class I Summary Report Not Required Not Required
IVD Class II Summary Report Health Canada Every 2 years
IVD Class III Summary Report Health Canada Annually
IVD Class IV Summary Report Health Canada Annually
USA
Class I PSURs/ PBRERs or PADERs/PAERs Not Required Not Required
Class II PSURs/ PBRERs or PADERs/PAERs US FDA As per standard US requirements every 3 months for two years and then yearly forever.

As per ICH (or EU) timing, then the 3 month and annual reports.
Class III PSURs/ PBRERs or PADERs/PAERs US FDA As per standard US requirements every 3 months for two years and then yearly forever.

As per ICH (or EU) timing, then the 3 month and annual reports
IVD Class I PSURs/ PBRERs or PADERs/PAERs Not Required Not Required
IVD Class II PSURs/ PBRERs or PADERs/PAERs US FDA As per standard US requirements every 3 months for two years and then yearly forever.

As per ICH (or EU) timing, then the 3 month and annual reports.
IVD Class III PSURs/ PBRERs or PADERs/PAERs US FDA As per standard US requirements every 3 months for two years and then yearly forever.

As per ICH (or EU) timing, then the 3 month and annual reports
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