Systematic post-market surveillance – for long-term compliance and market safety
The post-market phase poses complex regulatory challenges for manufacturers of medical devices and in-vitro diagnostics. With the stricter requirements of the MDR and IVDR, systematic monitoring of your products on the market is no longer an optional extra, but a legal obligation that determines the continued validity of your CE marking.
We can set up and optimize your post-market surveillance system for you, create the necessary reports and plans and organize clinical follow-ups. This not only reduces audit risks and secures your market access, but also creates a sound database for continuous product improvements.
What Post-Market Services include
Post-market surveillance is a proactive and systematic process in which manufacturers continuously record and evaluate experience with their products on the market. The aim is to identify previously unknown risks at an early stage, check the actual performance in everyday clinical practice and continuously update the risk-benefit assessment. If necessary, manufacturers must react quickly and initiate corrective or safety measures.
The MDR and IVDR require a documented post-market surveillance process as an integral part of your quality management system. This process must be defined on a product or product group-specific basis in a PMS plan that specifies which data sources you use, how you analyze trends and which measures you take in the event of anomalies. Typical data sources include customer feedback and complaints, service reports, results from clinical follow-ups, scientific literature, register data and reports on comparable products in government databases.
A key component of post-market services is the clear distinction between proactive monitoring (PMS) and reactive vigilance. While post-market surveillance collects data systematically and proactively, the vigilance system reacts to specific incidents and regulates their reporting to the authorities. Both systems are interlinked and together form the foundation for product safety after the product has been placed on the market.
We design and implement an MDR- or IVDR-compliant post-market surveillance system for you that is seamlessly integrated into your existing business processes. We define clear roles and responsibilities and create the necessary interfaces to your risk management, clinical evaluation, vigilance system and quality management system in accordance with ISO 13485.
For practical implementation, we create all the necessary procedural instructions and work instructions that guide your employees step by step through the processes of data collection, evaluation, assessment, CAPA derivation and documentation. If you would like to use digital tools for your PMS data management, we will support you in validating and selecting suitable software solutions in accordance with the requirements of ISO 13485. Our aim is to create a pragmatic system that reduces media disruptions and relieves your teams in a targeted manner without jeopardizing regulatory compliance.
Creation of PMS plans and safety reports
Each of your products or product groups requires a specific PMS plan in accordance with Annex III of the MDR or IVDR. We develop these plans together with you and define which data sources you monitor, which indicators and threshold values are relevant for trend analysis and at what intervals you evaluate the information collected.
Based on the data from your PMS system, we create the legally required reports for you: Post-Market Surveillance Reports (PMSR) for products in lower risk classes and Periodic Safety Update Reports (PSUR) for higher-class and implantable medical devices. In these reports, we combine the PMS results with your risk management file and clinical evaluation in a structured manner and conclusively justify the risk-benefit ratio of your products. In this way, we create a consistent, verifiable overall picture that provides your notified body and the competent authorities with the required transparency.
Post-market clinical follow-up and performance follow-up
The Post-Market Clinical Follow-up (PMCF) for medical devices and the Post-Market Performance Follow-up (PMPF) for in-vitro diagnostics is an integral part of your PMS plan. These clinical follow-ups serve to clarify open questions that could not be fully answered before the market launch.
We work with you to plan suitable PMCF or PMPF activities that match the issue and risk profile of your product. These can be clinical studies in accordance with ISO 14155, structured observational programs, user surveys or real-world evidence analyses. During the design phase, we define clear objectives, select relevant clinical endpoints, determine the methods for data collection and develop a sound evaluation strategy. Once the measures have been completed, we prepare the required PMCF or PMPF reports and derive any necessary updates for your clinical evaluation or performance assessment.
Vigilance and trend analysis
In addition to proactive post-market surveillance, you need a functioning reactive vigilance system that responds quickly to incidents and safety risks. We establish a process for you for the systematic recording, evaluation and timely reporting of serious incidents and safety corrective measures in the field in accordance with MDR or IVDR requirements.
The integration of your vigilance data into the higher-level PMS system is particularly important. We carry out trend analyses for you that detect signals at an early stage and alert you if defined threshold values are exceeded. This systematic evaluation enables you not only to react to individual incidents, but also to identify systematic problems or accumulations before they become major safety risks. When communicating with authorities and notified bodies, we support you with everything from CAPAs requiring notification to FSCA documentation and recall concepts.
Continuous risk management over the product life cycle
The findings from your post-market surveillance and clinical follow-up flow directly into your risk management in accordance with ISO 14971. We use the market data obtained to update your risk management files on an ongoing basis, whether this involves adjusting probabilities and severity levels, identifying new risks or reviewing your risk acceptance criteria.
If the post-market data reveals a specific need for action, we support you in implementing the necessary changes to instructions for use, labeling or technical specifications. We support you throughout the entire product life cycle – from market launch and ongoing product maintenance to the planned market exit, including defining the end of your monitoring obligations. This ensures that your products remain safe and efficient in the long term and that you are auditable and approvable at all times.
We have extensive project experience with medical devices of various classes (I to III) and software safety classes (A to C) and combine post-market surveillance, clinical evaluation, quality management and regulatory affairs into an integrated service package. You benefit from a pragmatic, audit-proof implementation that takes your existing company processes into account and relieves your teams in a targeted manner – from the initial gap analysis to the complete outsourcing of individual post-market tasks.
Post-market surveillance raises many questions. We have answered the most frequently asked ones for you. Your question is not listed? Please feel free to contact us.
