Post-market surveillance is a key to better and safer devices

2020-06-17 13:34

The Medical Device Regulation is significantly changing the regulatory framework for medical devices in Europe. One of the new major challenges is the increased focus on post-market surveillance. This forces pharmaceutical companies to be more proactive in data collection and analysis than previously. The key idea of post-market surveillance is to distinguish the defective devices on the market from those that are safe and effective.

Post-market surveillance aims at:

  • systematically identifying the above-mentioned risks when they occur during usage
  • monitoring performance of the products
  • detecting product faults and safety issues that have been left undetected
  • constantly updating the benefit-risk assessment
  • quickly initiating necessary measures, such as recall.

What are the main benefits for patients and consumers?

The new regulations is a way to a more patient-friendly environment, where transparency and information aimed at patients are a priority.

The new rules introduce, among others:

  • better protection of public health and patient safety
  • EU database on medical devices (EUDAMED)
  • a device identification system based on a unique device identifier (UDI) that will allow easier traceability of medical devices
  • an ‘implant card’
  • a robust financial mechanism to ensure patients are compensated.

Post-market surveillance services

Are you having trouble navigating the EU MDR, or are you looking for more information on how to comply with the EU MDR post-market surveillance requirements?

To meet the needs of the updated Medical Device Regulation, we at Biocodex Pharmaceutical and Medical Services team provide support for post-market surveillance:

  • Creation and maintenance of post-market surveillance system
    • PMS plan and, when applicable, PMS report
    • Periodic safety update report (PSUR)
  • Person responsible for the PMS activities
  • Vigilance
    • 24/7 incident reports reception and thorough case processing
    • timely and accurate regulatory reporting of incident reports
    • preparation and management of field safety corrective actions and field safety notices
    • signal detection and analysis trend report
    • screening of global medical literature to identify trends
    • vigilance quality system
  • Support in other main post-market surveillance responsibilities, such as:
    • processing and keeping a register of complaints, non-conforming devices, recalls and withdrawals
    • informing relevant parties about complaints and reports from healthcare professionals, patients and users concerning suspected incidents
    • co-operation with regulatory authorities
    • implementation of corrective actions.

Next step

Contact us to explore your medical device post-market surveillance requirements!
We are happy to help you together with my team.

– Susanna Heinonen, Head of Pharmacovigilance