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Day: November 14, 2023

Overview of Regulatory Requirement for Post-Marketing Medical Device Reporting in the USA and the EU

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Overview of Regulatory Requirement for Post-Marketing Medical Device Reporting in the USA and the EU

Meteriovigilance is the term used in the context of surveillance of medical devices and its purpose is to improve the protection of health and safety of patients, healthcare professionals, and other users by reducing the likelihood of reoccurrence of incidents related to the use of a medical device.

Presented below in brief is the post-marketing regulatory landscape as exist for USFDA and EMA in terms of Medical Device Reporting.

  1. Regulations that Govern Medical Device Reporting

  • USFDA
  • 21 CFR PART 803
  • 21 CFR PART 806
  • EMA
  • Regulation (EU) 2017/745

  1. Type of Report and Reporting Timelines

  • USFDA
  • 5-day report: No later than 5 workdays after becoming aware of a reportable event that requires
  • Remedial action to prevent an unreasonable risk substantial harm to the public health.
  • A reportable event for which FDA made a written request.
  • 30-Day report: No later than 30 calendar days after becoming aware of a reportable death, serious injury, or malfunction
  • EMA
  • Serious public health threat: Immediately, but not later than

days after the manufacturer becomes aware of that threat.

  • Death or an unanticipated serious deterioration in a person’s state of health: Immediately, but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident.
  • Other serious incident: Immediately, but no later than 15 days after manufacturer become aware of the incident.

  1. Method to submit Reportable Medical Device Reports

  • USFDA
    • Electronic Submissions Gateway (Web Trader)
    • Gateway to Gateway
  • EMA
    • Submission of Manufacturer’s Incident Report (MIR) form via email to the approving Competent Authority.
    • Under development: EUDAMED

  1. Requirement for submission of Periodic Report

  • USFDA
    • Not mentioned*
    • Guidance for Combination product has specific requirements; will be detailed in subsequent posting.
  • EMA
    • Class IIb and class III devices: Annual PSUR Submission
    • Class IIa devices: PSUR to be submitted at least every two years

  1. Requirement for Trend reporting

  • USFDA
  • Not mentioned
  • EMA
  • Manufacturers shall electronically report any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side effects that could have a significant impact on the benefit-risk analysis, and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits

Navigating the Unique Challenges of AI and Automation in Pharmacovigilance: The Vital Role of Computer System Validation (CSV)

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Artificial Intelligence, Machine Learning, Automation, Cost Reduction: all the buzzwords in pharmacovigilance! Everyone seems to be implementing Automation and AI in pharmacovigilance to reduce manual work and reduce costs of safety monitoring. However, compared to all other fields where Automation and AI is being implemented, pharma as an industry is facing a unique set of challenges in implementing these systems.

 

Regulators such the USFDA and EMA require that computerized systems should be fit for intended use and meet current regulatory requirements. ‘Fit for intended use’ is a broad term that encompasses detailed testing, documentation, qualification and validation activities to demonstrate that the ‘use’ and ‘fitness for such use’ of a system is demonstrated effectively and is available for review during audits and inspections.

 

The method for achieving this is Computer System Validation, which is rooted in the principles of Good Automated Manufacturing Practice (GAMP), Title 21 CFR Part 11, and EU Annex 11. In the pharma space, the requirements become all the more critical, since it is no longer just about compliance; it’s about safeguarding lives.

 

The Indispensable role of CSV in Pharmacovigilance

End Point Regulation Requirement How CSV Helps to Achieve the Requirement
Patient Safety EU Annex 11 Patient Safety Aids in the timely detection, management, and mitigation of risks associated with pharmaceutical products
Data Precision GAMP Precise Reporting Ensures data accuracy, reducing the risk of errors that could significantly impact patient safety.
Regulatory Compliance Title 21 CFR Part 11, EU Annex 11 Robust compliance standards for

electronic records and signatures in

FDA-regulated industries, guidelines

For computerized systems in the

European Union

 Adherence to these regulations, ensuring that you consistently meet the stringent requirements of regulatory authorities
Operational Efficiency GAMP, Title 21 CFR, and EU Annex 11 Importance of efficient systems Streamlined processes not only improve productivity but also lead to faster responses, an invaluable asset in pharmacovigilance where time can mean the difference between life and death

 

In the next few parts of this series, I will be discussing some approaches that we have followed in implementing CSV procedures for software systems developed for the pharmacovigilance space, what we have learned in the process, how CSV can be applied by harmonizing international regulatory requirements and how it can

be applied to the agile development. Stay tuned for more updates and reach out to me if you would like to see any other topics covered as part of the series.