What is market surveillance?
Market surveillance refers to actions undertaken by EU Member State authorities and notified bodies to ensure that medical devices available on the European Union market comply with MDR 2017/745 and IVDR 2017/746 regulations. The objective of market surveillance is to protect public health by identifying non-compliant, potentially hazardous, or counterfeit products and implementing corrective, restrictive, or withdrawal measures.
Unlike the PMS system, which is an internal obligation of the manufacturer, market surveillance is carried out by independent external authorities and often results in inspections, audits, or requests for documentation. This system is closely related to vigilance — the process of reporting and analyzing serious incidents by the manufacturer — but its scope is broader and covers the entire availability of the product in the EU.
While PMS is aimed at evaluating the long-term benefit-risk ratio, vigilance and market surveillance respond to immediate and current risks to patient health and safety.
MDR requirements for market surveillance
The MDR Regulation, in Chapter VII, imposes obligations on manufacturers, importers, and surveillance authorities to respond quickly to risks posed by devices on the market. Key manufacturer obligations include:
- reporting serious incidents to the vigilance system within a maximum of 15 days after detection,
- monitoring and analyzing trends in non-serious incidents and product malfunctions,
- identifying root causes and implementing appropriate CAPA actions,
- submitting reports to the EUDAMED system, bypassing national reporting systems,
- cooperating with market surveillance authorities during inspections or when requested to provide explanations.
These requirements align with MEDDEV 2.12-1 rev. 8 and serve to harmonize practices across the EU, eliminating discrepancies between Member States.
The role of EUDAMED in market surveillance
EUDAMED (European Database on Medical Devices) serves as a central information system for medical devices and IVDs in the EU. According to Article 92 MDR, vigilance reports and Field Safety Corrective Actions (FSCA) are published in EUDAMED, allowing manufacturers, authorities, and notified bodies to:
- exchange information quickly on incidents and corrective actions,
- monitor safety trends for specific device types,
- increase transparency and user trust.
Integration of vigilance with the quality management system
The vigilance process must be integrated into the manufacturer’s quality management system, in line with the requirements of ISO 13485. This integration enables effective management of market data and its translation into improvement actions and updates to technical documentation.
As part of this integration, the manufacturer should implement procedures that enable:
- classification of incidents based on risk level and clinical impact,
- continuous data analysis and statistical trend assessment,
- implementation of corrective and preventive actions (CAPA),
- recording actions within the quality system and documentation,
- periodic review and update of the risk analysis.
Changes to timelines and obligations under MDR
The MDR introduced significant changes to reporting timelines and expanded vigilance responsibilities. Key changes include:
- reducing the deadline for reporting serious incidents from 30 to 15 calendar days,
- requiring the reporting of significant trends in non-serious incidents,
- extending vigilance obligations to manufacturers of IVDs,
- requiring an integrated reporting system through EUDAMED,
- necessitating updates to internal procedures and training for regulatory compliance personnel.
Effective implementation of these obligations requires modern data management tools and close collaboration between quality, regulatory, and R&D departments.
How Pure Clinical supports market surveillance and vigilance
Pure Clinical offers comprehensive support for manufacturers of medical and diagnostic devices in fulfilling market surveillance and vigilance obligations. Our services include:
- developing and implementing vigilance procedures in compliance with MDR and ISO 13485,
- risk assessment and monitoring of adverse event trends,
- preparation and management of incident reports in the EUDAMED system,
- coordination of corrective and preventive actions (CAPA),
- integration of vigilance with PMS, QMS, and technical documentation,
- training for teams responsible for compliance, safety, and product quality.
Our experience includes work with high-risk devices (Class III), implants, active devices, and Class D IVDs. We help manufacturers not only remain compliant with regulations but also reduce market surveillance risks and increase transparency and end-user trust.
FAQ
What are the key differences between market surveillance and a notified body audit?
Market surveillance is conducted by national authorities to monitor products already placed on the market, while a notified body audit evaluates the manufacturer’s quality system before or during product conformity assessment. Both are independent but may interact in cases of noncompliance.
Can market surveillance authorities act without prior notice?
What penalties can a manufacturer face for non-cooperation with market surveillance bodies?