What post-market surveillance does the GPSR require?

Under the General Product Safety Regulation (EU) 2023/988 (GPSR), post-market surveillance means actively monitoring your consumer product’s safety after it is placed on the EU market. You are expected to collect safety information, review complaints and accidents, spot trends in foreseeable use or misuse, and act quickly when risks appear. A practical system also keeps records and makes safety information easy to retrieve if authorities ask.

What post-market surveillance does the GPSR require?

GPSR post-market surveillance requires economic operators to keep checking whether products remain safe after sale, using real-world feedback and other safety signals. This includes gathering information, assessing it, and deciding whether action is needed, with procedures that match the product’s risk level and the way consumers actually use it.

In practice, post-market surveillance under the GPSR typically includes:

Collecting safety information from customers, distributors, service partners, and online channels.
Monitoring complaints and accidents, including near-miss incidents that could reasonably lead to harm.
Tracking performance under foreseeable conditions, including foreseeable misuse, vulnerable users, and interactions with other products.
Reviewing changes that can affect safety, such as design updates, component substitutions, new instructions, or software updates, where relevant.
Maintaining internal procedures for triage, risk assessment, decision-making, and follow-up, proportionate to the product’s hazards and distribution scale.

The GPSR works as a safety net, and for products also covered by EU harmonisation legislation, you must still monitor and address risks that are not fully covered elsewhere.

How do you set up a GPSR-compliant post-market surveillance system?

A GPSR-compliant post-market surveillance system is a documented, risk-based process that turns field feedback into decisions you can justify to authorities. It should define who does what, where data comes from, how you escalate safety signals, and how you record outcomes so the information is retrievable without delay.

Assign roles and responsibilities for intake, assessment, decision-making, and communications, including backups to ensure continuity.
Set up data channels for customer complaints, returns, warranty claims, repair reports, distributor feedback, and online reviews.
Define escalation thresholds; for example, any report of injury, fire, choking risk, electric shock, or repeated failures in normal use should trigger immediate review.
Run periodic safety reviews at a frequency proportionate to risk, sales volume, and product complexity.
Document decisions, including what you reviewed, your risk rationale, and why you chose a specific action—or no action.
Link to traceability and technical documentation so you can identify affected batches, versions, listings, and destinations.

Records to keep usually include complaint logs, accident summaries, investigation notes, risk assessments, corrective action decisions, consumer communications, and effectiveness checks. Store them in a controlled manner so you can provide them promptly if requested by market surveillance authorities.

When must you notify authorities, and what corrective actions are expected under the GPSR?

You should act as soon as post-market surveillance indicates a product may be unsafe, starting with a risk assessment and then selecting corrective actions that effectively reduce risk. Notification to authorities is generally expected when there is a serious risk, but the exact process and timing depend on the Member State authority and the specifics of the case.

Corrective actions commonly expected under the GPSR include:

Warnings and updated instructions when risk can be controlled through clear consumer information.
Withdrawal (stopping supply and removing offers) when continued availability creates an unacceptable risk.
Recall when products already with consumers need to be returned, repaired, replaced, or otherwise made safe.

For notifications and coordination, businesses may be directed to use the Safety Business Gateway, which supports safety-related workflows connected to the Safety Gate system. You should also be ready to cooperate with authorities, provide requested documentation, and verify that corrective actions are effective—for example, confirming that listings are removed and that recall communications have reached consumers.

Role clarity matters: under the Market Surveillance Regulation (EU) 2019/1020 (MSR), the Responsible Person is an economic operator that must inform the manufacturer when it has reason to believe a product presents a risk, while serious-risk notifications to authorities are handled by the Authorised Representative when that role is appointed.

How does EARP help with GPSR post-market surveillance and compliance?

We help non-EU manufacturers and sellers build practical GPSR post-market surveillance readiness and maintain smooth cooperation with EU market surveillance authorities, including support aligned with Responsible Person and optional Authorised Representative arrangements.

Set up and document post-market surveillance procedures, roles, and escalation rules
Check safety documentation for presence and completeness, then organise it for fast retrieval
Store documentation and make it available to authorities upon request
Triage safety signals and accidents, then coordinate next steps with you
Support authority liaison and corrective action coordination, including withdrawal and recall logistics

See our services, or contact us to discuss your products and the post-market surveillance process you need for GPSR compliance.

What post-market surveillance does the GPSR require?