What post-market monitoring is required for connected smart devices?

Post-market monitoring for connected smart devices involves ongoing surveillance of products after they reach consumers, including tracking safety performance, collecting user feedback, and monitoring software updates for potential risks. Under the General Product Safety Regulation (EU) 2023/988 (GPSR), manufacturers must continuously assess their devices’ safety throughout their lifecycle, respond to emerging threats, and maintain detailed documentation of all monitoring activities.

What exactly is post-market monitoring for connected smart devices?

Post-market monitoring is the systematic surveillance of connected smart devices after they enter the market to ensure ongoing safety and compliance. This process requires manufacturers to actively track device performance, collect safety data, and assess emerging risks throughout the product’s entire lifecycle.

For IoT device monitoring, this obligation extends beyond traditional product surveillance. Connected devices present unique challenges because they receive software updates, connect to networks, and interact with other systems in ways that can introduce new safety risks after the initial market placement.

The GPSR mandates that manufacturers maintain internal product safety processes that enable continuous compliance monitoring. These processes must include:

Quality controls and testing procedures
Staff training on product safety requirements
Procedures for handling accident reports and complaints
Risk assessment protocols for software updates

The regulation recognises that connected devices require ongoing attention due to their dynamic nature and potential for remote modification through software updates.

What specific monitoring activities must manufacturers perform for smart devices?

Manufacturers must implement comprehensive monitoring systems that track multiple aspects of their connected devices’ performance and safety. The regulatory landscape includes multiple layers of oversight. Organizations like BEUC (the European Consumer Organisation) supplement government enforcement by investigating complaints, testing products, and pushing for recalls when manufacturers fail to meet safety obligations. This multi-tiered approach ensures comprehensive protection for consumers across all market channels.

Manufacturers who fail to meet safety standards face real consequences. The EU’s Safety Gate system publicly documents violations, creating a searchable record of companies whose products have been flagged as dangerous and removed from the market. This transparency mechanism serves as both a consumer protection tool and a powerful incentive for manufacturers to maintain rigorous safety standards.

The following table outlines the key monitoring activities and their requirements:

Monitoring Activity	Key Requirements	Frequency
Accident Tracking	Document incidents, notify authorities without delay	Immediate upon discovery
Consumer Feedback Analysis	Accessible communication channels, disability compliance	Continuous
Software Update Monitoring	Risk assessment for modifications, safety impact evaluation	With each update
Cybersecurity Threat Assessment	Monitor emerging threats, evaluate device vulnerabilities	Ongoing
Performance Data Collection	Track device functionality, identify safety patterns	Continuous

Accident notification represents a critical monitoring requirement. When manufacturers have knowledge of accidents involving their products, they must inform relevant parties without undue delay. For manufacturers outside the EU, this information goes to the designated responsible person, who ensures that authorities receive proper notification through the Safety Business Gateway.

Consumer feedback analysis requires establishing accessible communication channels for complaints, accidents, and safety issues. If manufacturers fail to provide these channels, their responsible person must establish them, ensuring accessibility for persons with disabilities.

Software update monitoring becomes particularly important for connected devices. Any substantial modification—whether physical or digital—that affects the product’s nature and characteristics, was not foreseen in the initial risk assessment, or jeopardises safety creates new manufacturer obligations for the modified aspects.

How do you handle safety issues discovered during post-market monitoring?

When you identify safety concerns through monitoring, you must follow a structured response process with clear steps and timelines:

Immediate Response Actions

Inform the manufacturer immediately – Enable quick issue resolution
Assess the severity – Determine if the risk qualifies as serious
Document the issue – Create detailed records for authorities
Implement interim measures – Take immediate steps to protect consumers

Corrective Measures

If the manufacturer fails to take appropriate corrective measures, the responsible person must implement them directly. Available corrective measures include:

Product recall from end users
Market withdrawal from distribution channels
Sales cessation
Risk warning markings on products
Consumer warnings and safety alerts

For serious safety risks, you must provide clear, understandable descriptions of health and safety risks to authorities, detail corrective measures already taken, and specify quantities still circulating by Member State, if available. The Safety Business Gateway serves as the primary tool for simultaneous authority and consumer alerts.

Consumer information becomes mandatory for product safety recalls and safety warnings. You must reach affected customers directly through available personal data, customer loyalty programmes, or registration schemes. The information can vary in detail and technicality for different audiences, but recall notices must follow all specified requirements.

What documentation and reporting obligations come with post-market monitoring?

Post-market monitoring requires maintaining comprehensive documentation with specific retention periods and reporting formats. You must keep technical documentation updated and retain it for 10 years after market placement, along with detailed records of all monitoring activities and communications with authorities.

Documentation Retention Requirements

Document Type	Retention Period	Key Contents
Technical Documentation	10 years	Full risk descriptions, product specifications
Safety Records	10 years	Complaints, accidents, corrective measures
Traceability Information	6 years	Supplier details, distribution chain records
Monitoring Reports	10 years	Performance data, safety assessments

10-year retention requirements include:

Full descriptions of risks presented by products
Complaints related to products
Known accidents and incident reports
Descriptions of corrective measures to address risks

This information must be supplied when requested by market surveillance authorities.

Traceability information requires 6-year retention and covers suppliers who provided the product, parts, components, or embedded software, plus economic operators to whom products were supplied. This creates a complete chain of responsibility for connected smart devices.

Progress reports may be required as regular updates to authorities on corrective measures. The Market Surveillance Regulation (EU) 2019/1020 (MSR) establishes these reporting frameworks to ensure continuous oversight of product safety throughout the market lifecycle.

Key Benefits of Effective Post-Market Monitoring

Consumer Protection – Early identification and resolution of safety issues
Business Protection – Reduced liability and regulatory compliance
Market Access – Maintained compliance across EU markets
Brand Reputation – Proactive safety management builds trust

Effective post-market monitoring protects both consumers and your business interests by identifying and addressing safety issues before they escalate. The connected nature of smart devices makes this ongoing surveillance particularly important, as new risks can emerge through software updates, network interactions, or changing usage patterns. We specialise in helping manufacturers navigate these complex obligations while maintaining seamless market access across the EU.

If you are looking for support or to learn more, contact our team of experts today.