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