GPSR compliance is an important consideration for manufacturers supplying consumer products to the EU. The General Product Safety Regulation (GPSR) replaced the EU’s General Product Safety Directive in December 2024. It introduced updated requirements for businesses placing consumer products on the EU market.
For UK manufacturers selling into the EU, understanding these obligations is essential. Businesses must know which requirements apply to their products and how to manage them. Meanwhile, manufacturers supplying both UK and EU markets must also consider the differences between the two regulatory frameworks.
This article explains what GPSR compliance involves, who it applies to and the main obligations manufacturers must meet.
What is GPSR and why does it matter?
The General Product Safety Regulation (GPSR) establishes safety requirements for consumer products sold in the EU. It became applicable on 13 December 2024, replacing the General Product Safety Directive (GPSD).
The underlying principle remains the same: businesses must only place safe products on the EU market.
However, GPSR introduces more detailed obligations for manufacturers and other businesses within the supply chain. These include product traceability, technical documentation, incident reporting and consumer safety information.
The regulation also strengthens requirements for online sales and clarifies the responsibilities of different economic operators.
GPSR primarily applies to consumer products. However, some products already fall under specific EU safety legislation. These include medical devices and food products, which have their own regulatory frameworks.
Where sector-specific legislation already addresses particular safety risks, the relevant provisions of that legislation take precedence. Manufacturers should therefore establish which requirements apply to their products before placing them on the market.
Who does GPSR apply to?
GPSR establishes responsibilities for several businesses involved in supplying consumer products to the EU.
Manufacturers carry primary responsibility for product safety. However, importers and distributors must also fulfil specific obligations.
Manufacturers
Manufacturers must ensure their products meet the relevant safety requirements before placing them on the EU market.
To demonstrate compliance, they need to assess product risks, maintain technical documentation and provide appropriate safety information.
They must also establish procedures for managing complaints, investigating incidents and carrying out product recalls when necessary.
In addition, manufacturers must cooperate with market surveillance authorities and provide relevant documentation when requested.
Importers
Importers have specific responsibilities when introducing products from outside the EU into the European market.
They must check that manufacturers have fulfilled their obligations and supplied the necessary documentation.
Importers also need to verify that products carry appropriate identification and safety information.
If an importer identifies an unsafe product, they must take appropriate action. This may include notifying authorities, supporting corrective measures or arranging a product recall.
Distributors
Distributors must exercise due care when making consumer products available on the EU market.
Their responsibilities include checking that products carry the required identification, instructions and safety information.
Although their obligations differ from those of manufacturers and importers, distributors still play an important role in product safety.
For example, they must respond appropriately if they discover that a product presents a safety risk.
Key GPSR compliance requirements for manufacturers
GPSR introduces several obligations that manufacturers must address before placing consumer products on the EU market.
These requirements cover product safety, documentation, traceability and the management of potential risks.
Product safety and risk assessment
Manufacturers must assess product safety before placing products on the market.
GPSR does not prescribe one assessment method for every product. Instead, manufacturers must select an approach appropriate to the product’s characteristics and potential risks.
The assessment should consider how consumers will use the product and any reasonably foreseeable misuse.
Manufacturers must also consider vulnerable users, including children, where relevant.
Where applicable EU harmonised standards exist, meeting those standards can provide a presumption of conformity with the safety requirements they cover.
Technical documentation
Manufacturers must maintain technical documentation that demonstrates how they have assessed product safety.
This documentation should identify relevant risks and explain the measures taken to address them.
The level of detail will depend on the product and its potential hazards.
However, manufacturers must keep the information current and make it available to market surveillance authorities when requested.
Accurate documentation therefore plays an important role in demonstrating GPSR compliance.
Traceability
GPSR places significant emphasis on product identification and traceability.
Manufacturers must ensure that products carry sufficient information to identify their origin. This includes product identification details, such as type, batch or serial numbers where appropriate.
Products must also carry the required manufacturer identification and contact information.
Effective traceability helps businesses identify affected products when safety concerns arise.
As a result, manufacturers can investigate incidents more efficiently and take corrective action where necessary.
Product information and labelling
Manufacturers must provide consumers with the information they need to use products safely.
Depending on the product, this may include instructions, safety warnings and other relevant information.
Businesses must also consider the language requirements of the EU countries where they intend to sell their products.
GPSR addresses digital product information alongside physical labelling requirements. However, digital information does not automatically replace mandatory information that must accompany the product.
Manufacturers therefore need to establish how they will maintain accurate and accessible product information across their sales channels.
Incident reporting and market surveillance cooperation
GPSR establishes requirements for reporting product safety incidents and cooperating with regulatory authorities.
When manufacturers identify a dangerous product, they must take appropriate corrective action and notify the relevant authorities without undue delay.
The EU’s Safety Business Gateway provides a mechanism for submitting product safety notifications.
Manufacturers must also report qualifying accidents associated with their products in accordance with the regulation.
Furthermore, businesses must cooperate with market surveillance authorities during investigations and provide requested information.
Clear internal reporting procedures can help manufacturers identify concerns, escalate incidents and respond within the required timescales.
Recalls and corrective actions
When a product presents a safety risk, manufacturers must take appropriate corrective measures.
Depending on the circumstances, these may include withdrawing products from sale, issuing safety warnings or initiating a recall.
GPSR also establishes requirements for communicating product recalls to consumers.
Manufacturers must provide clear information about the affected product, the associated risks and the action consumers should take.
Where businesses hold customer contact information, they may also need to notify affected consumers directly.
Consequently, effective recall procedures and reliable product traceability are essential for responding to safety incidents.
GPSR compliance and UK manufacturers
GPSR is an EU regulation and does not automatically apply to products sold exclusively in Great Britain.
However, UK manufacturers supplying consumer products to the EU must meet the applicable GPSR requirements.
This includes businesses exporting directly to European customers or selling through online marketplaces that serve EU consumers.
The regulation focuses on where businesses place products on the market, rather than where they manufacture them.
UK manufacturers must therefore assess their obligations before supplying products to EU customers.
In addition, GPSR requires an economic operator established within the EU to fulfil specified product safety responsibilities.
UK manufacturers without an appropriate EU-based economic operator may need to appoint an authorised representative or establish another compliant arrangement.
The position can vary depending on the product, supply chain and applicable legislation.
Northern Ireland also has distinct product safety arrangements. Manufacturers supplying that market should check the relevant requirements rather than assuming that Great Britain’s rules apply.
Meanwhile, UK product safety legislation continues to develop separately.
Businesses operating across multiple markets should therefore monitor both frameworks and review their compliance arrangements accordingly.
Building a GPSR compliance checklist approach
A GPSR compliance checklist provides manufacturers with a practical starting point for reviewing their responsibilities.
Although a checklist cannot replace a detailed regulatory assessment, it can help quality and operations teams identify potential gaps.
It also provides a structured way to assign responsibilities and monitor progress.
The main areas to review include:
- Product safety assessment: Has the manufacturer assessed and documented the risks associated with each relevant product?
- Technical documentation: Are product safety records complete, current and available for regulatory inspection?
- Traceability: Can the business identify products and trace them through the supply chain to their source?
- Labelling and product information: Do products carry the necessary identification, instructions and safety warnings in the required languages?
- Incident management: Does the business have a clear process for identifying, recording and escalating product safety concerns?
- Recall readiness: Can the manufacturer initiate a recall, notify the appropriate authorities and communicate with affected consumers?
- Supply chain responsibilities: Do manufacturers, importers and distributors understand their respective obligations?
- EU responsible person: Has the business identified an appropriate EU-based economic operator to fulfil the relevant responsibilities?
Manufacturers should review these areas regularly, particularly when products, suppliers or sales markets change.
By doing so, they can identify potential compliance issues before those problems affect customers or result in regulatory intervention.
How compliance management supports GPSR readiness
GPSR compliance requires ongoing attention to product safety, documentation and traceability.
Manufacturers must maintain accurate records and respond promptly when incidents or regulatory enquiries arise.
For businesses managing multiple products, production sites or international markets, these responsibilities can create significant administrative demands.
Spreadsheets and disconnected document storage systems may make it difficult to maintain a consistent view of compliance activities.
For example, quality teams may need to search several locations to retrieve risk assessments, product records or corrective action information.
Dedicated compliance management software can help businesses organise these activities more effectively.
Digital systems provide a structured way to record compliance checks, manage supporting evidence and monitor outstanding actions.
In addition, centralised information can make it easier for teams to review compliance activity and identify areas requiring attention.
However, software alone does not establish GPSR compliance. Manufacturers still need appropriate procedures, product-specific assessments and clear accountability.
The aim is to support consistent compliance management throughout everyday operations rather than gathering evidence only when an inspection or incident occurs.
The gap between knowing the requirements and managing them consistently
GPSR compliance establishes important responsibilities for manufacturers supplying consumer products to the EU.
These include product safety assessments, technical documentation, traceability, incident reporting and corrective action procedures.
However, understanding the requirements is only the starting point.
Manufacturers must also establish reliable processes to manage these obligations throughout the product lifecycle.
This involves maintaining accurate records, assigning responsibilities and ensuring employees can access the information they need.
When businesses manage compliance consistently, they are better prepared to respond to safety concerns and regulatory enquiries.
If you want a platform that brings structure, traceability and audit readiness into your compliance processes, explore how Gemba Compliance supports manufacturers with a practical, site-level approach to managing product and manufacturing compliance