The introduction of the European legal framework for medical devices through the Medical Device Regulation (MDR) and the In-vitro Diagnostic Medical Devices Regulation (IVDR) has significantly tightened the requirements for post-market surveillance (PMS) in recent years. The PMS includes all processes and systems that manufacturers must put in place to actively and systematically collect, record and analyse data on the quality, performance and safety of a product throughout its life cycle. A crucial part of this comprehensive PMS system is the so-called vigilance – the process which deals in particular with reporting safety-related incidents and potential risks to the authorities and initiating appropriate corrective and preventive measures.
In this article we take a detailed look at vigilance as an integral but not exclusive component of the PMS system.
What is vigilance?
Under vigilance In the field of medical devices, this means the continuous and systematic collection, documentation and evaluation of all safety-relevant data on a medical device, after it was introduced to the marketVigilance is therefore the core of the official reporting obligations and includes, among other things:
- Reports of incidents such as malfunctions or unexpected side effects
- User reports, e.g. doctors, nursing staff or patients
- Results from studies (e.g. post-market clinical follow-up, PMCF)
- Feedback from authorities, distributors and other stakeholders
While the PMS system as a whole collects, documents and uses all data relating to quality, performance and safety for the continuous improvement of the product, the vigilance primarily on the Reporting safety-relevant events and dealing with the resulting measuresThis ensures that potential risks are identified at an early stage and corrective or preventive measures can be taken promptly. This not only serves to ensure patient safety, but also strengthens trust in medical devices and contributes to sustainable product improvement.
Legal Framework and Responsibility
1. MDR and IVDR
The MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746) have revised the requirements for placing medical devices on the market in the EU. Both regulations require manufacturers to set up a robust PMS system, which also includes vigilance. The PMS system has the overarching purpose of Collect and evaluate data throughout the entire life cycle of a medical device.
2. Roles and responsibilities
- Manufacturer have primary responsibility for setting up and maintaining an appropriate PMS system. Within this system, they must clearly define and adhere to processes for recording, evaluating and reporting incidents.
- Authorized Representatives in the EU area assume similar obligations if the manufacturer is based outside the EU.
- distributors and importers are obliged to report safety-relevant incidents to the manufacturer immediately.
- authorities such as the Federal Institute for Drugs and Medical Devices (BfArM) in Germany collect and analyze the reports. They can order measures if necessary.
The Process of Vigilance in the Context of PMS
1. Data collection and reporting management
The vigilance process begins with the systematic collection of all relevant data sources. These may be complaints, clinical studies, literature searches or reports from healthcare institutions. As soon as a report is received, the manufacturer (or its authorised representative) must check whether it is a reportable incident is.
Important factors for a reportable incident are:
- Deaths, serious deterioration of health or serious risks
- Previously unknown or unexpected side effects
- Significant technical malfunctions that pose a potential hazard
2. Assessment and risk analysis
After the recording, the Evaluation of the reports: How serious is the incident? Is it an isolated problem or is there a systematic error? For this purpose, risk assessments are carried out on the basis of existing data (e.g. from clinical studies or from the risk management process).
3. Corrective actions and feedback
The evaluation may result in: Corrective and Preventive Actions (CAPA) Typical measures can be:
- recall of the product or affected batches
- software updates or design adjustments
- Extensions or clarifications of the instructions for use
- Adaptation of packaging or labeling
The vigilance processes provide the framework when which messages to the authorities and which preventive measures must be initiated. Effective implementation of these measures requires that all relevant actors – from suppliers to users – are informed and trained in a timely manner.
4. Documentation and Reporting
All steps within the vigilance process must be carefully documented in order to be able to demonstrate to both the authorities and the notified bodies during audits and inspections that the legal requirements are met. The following documents are usually created or updated:
- incident reports and their assignment
- risk assessments and analysis methods
- action plans (CAPA process) and implementation reports
- Follow-up of measures (are they working as planned?)
Practical tips for successful vigilance and PMS
- Early planning: Integrate both PMS and vigilance processes during the product development phase so that you can react quickly when the product is launched on the market.
- Clearly defined roles: Ensure that responsibilities for PMS and in particular the vigilance reporting structures are clearly assigned.
- Efficient reporting management: Establish internal communication channels and external platforms (hotlines, online portals) so that reports reach the right contact person immediately.
- Regular training: Train employees and distributors on how to recognize, report and handle safety-related events.
- Continuous Improvement: Use the results from PMS and vigilance not only to meet legal requirements, but also as an opportunity to continuously optimize your products.
Bottom line
Vigilance is central element of the Post Market Surveillance system more than just a legal obligation – it is an essential part of quality management and product responsibility. While the PMS collects data on quality, performance and safety in a holistic manner, vigilance focuses on the reporting management and initiating any necessary measures. By continuously collecting, evaluating and (in the event of incidents) reporting data from the field, it can be ensured that risks are identified early and measures are implemented promptly. In this way, vigilance not only strengthens trust in a medical device, but also makes an important contribution to constantly improving the company's own product range and ensuring patient safety in the long term.
Those who plan the vigilance process strategically and integrate it into a holistic PMS system not only remain compliant with the law, but also ensure the quality standards and reputation of their company.
Are you looking for support in setting up or optimizing your vigilance and PMS processes?
Our experts will be happy to advise you on all aspects of risk management, reporting management and communication with authorities. Benefit from our expertise to make your processes legally compliant and efficient.
Notice: This article is for informational purposes only and does not constitute legal advice.
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