Design Control
Post-Market Surveillance
Efficient process for practicability and added value
Post-Market Surveillance is to be understood as a comprehensive process with numerous interfaces. Only an efficient process ensures practicability and added value for the company.
Post-Market Surveillance (PMS) - Surveillance after placing Medical Devices on the market
For every Medical Device, a Post-Market Surveillance system must be planned, documented, implemented, and kept up to date.
The aim is to use this system to consistently collect and actively record and analyze data on the quality, performance, and safety of the Medical Device during its service life and to initiate and monitor the necessary preventive or corrective measures.
The new Medical Device Regulation (MDR) tightens requirements for post-marketing surveillance and significantly increases the focus on the collection of clinical data. This is because clinical data must also be collected and evaluated by the manufacturer as part of post-market clinical follow-up (PMCF). The focus is on proactive data collection.
Interfaces of the Post-Market Surveillance process
The PMS system has process interfaces to:
- Risk Management
- Production and labeling
- Clinical Evaluation
- CAPA and Vigilance System
- Engineering
- Technical Documentation
Challenges in Post-Market Surveillance and Vigilance of Medical Devices - Are you also familiar with this?
PMS, PMCF, PSUR. As difficult as it is to align these terms, installing an appropriate Post-Market Surveillance system has its own challenges such as:
- The system has many interfaces to other processes in your company
- Post-Market Surveillance activities must be planned
- The evidence and actions are to be filed in a report for each Device or Device group.
The topic of vigilance continues:
- When does an incident become a serious incident??
- Which Field Safety Corrective Action (FSCA) is appropriate?
- What are the deadlines and criteria for reporting to the authorities?
Vigilance for Medical Devices - the Medical Device monitoring and reporting system
In the MDR, the deadline for reporting serious incidents has changed. As before, serious incidents and Field Safety Corrective Actions (FSCA) must be reported to the responsible authorities within specified deadlines. As previously, serious incidents are those that could have or have resulted in death, serious deterioration of a person's state of health, or serious public health threat.
It is also necessary to report statistically significant increases in the frequency or severity of NON-serious incidents that significantly affect the previous benefit-risk assessment of the Medical Device or Medical Device group. The PMS plan shall specify the method by which "significant increases" are identified.
News
Common Criteria for Information Technology Security Evaluation
Common Criteria (CC): International IT security standards for medical devices, supported by BSI and BfArM, enhance cybersecurity and trust in processes.
Clinical evaluation of eyeglasses
Both prescription and non-prescription eyeglasses are considered medical devices under the regulatory framework of the Regulation (EU) 2017/745.
Clinical Evaluation for Medical Devices in China
The field of medical devices is rapidly evolving, and as technological advancements continue, so do the regulatory frameworks governing their approval and marketing.
20 years of medical technology approval
We are celebrating our anniversary. We have been a partner to the healthcare industry for 20 years and support companies with the approval of medical products