General Product Safety Regulation 2024: What SMEs and Engineers Need to Know Before the Deadline

The General Product Safety Regulation (GPSR) — Regulation (EU) 2023/988 — came into force on 13 December 2024, replacing the General Product Safety Directive (GPSD) 2001/95/EC after more than two decades. For any business placing consumer products on the EU market, this is not an incremental update. It is a comprehensive rewrite that introduces new obligations around online marketplaces, digital product traceability, and economic operator responsibilities that simply did not exist under the old framework.

If you manufacture, import, distribute, or sell consumer products in the EU — and those products are not already fully covered by a sector-specific directive such as the Low Voltage Directive (2014/35/EU) or the Machinery Regulation (EU) 2023/1230 — GPSR almost certainly applies to you. Understanding what has changed, and acting on it before enforcement ramps up, is the practical priority for 2025.

---

What Is the General Product Safety Regulation and Who Does It Apply To?

The General Product Safety Regulation is an EU-wide horizontal regulation that establishes a safety baseline for all consumer products not covered — or only partially covered — by sector-specific product legislation. Because it is a Regulation rather than a Directive, it applies directly in all EU Member States without needing national transposition, which eliminates the patchwork of slightly different national laws that existed under the GPSD.

Scope: Which Products Are Covered?

GPSR covers products made available to consumers — including those supplied free of charge — with some important carve-outs:

• Fully in scope: Consumer products not regulated by other EU product safety legislation (toys, furniture, clothing, household goods, sports equipment, etc.)
• Partially in scope: Products covered by sector legislation that does not address all safety aspects (e.g., electrical appliances where the LVD covers electrical safety but GPSR fills any gaps)
• Out of scope: Medicinal products (Directive 2001/83/EC), food (Regulation (EC) 178/2002), antiques, products needing repair before use (if clearly labelled), aircraft subject to Regulation (EC) 216/2008

A critical point for engineers: even if your product carries a CE mark under a specific directive, GPSR may still apply to safety risks not covered by that directive. Do not assume CE marking automatically satisfies GPSR obligations.

Economic Operators Under GPSR

One of the most significant structural changes in the General Product Safety Regulation 2024 is the explicit expansion of responsibilities beyond manufacturers and importers. The regulation defines the following duty-bearers:

• Manufacturers — primary obligation; must ensure products are safe before placing them on the market
• Authorised representatives — must be established in the EU if the manufacturer is outside the EU
• Importers — responsible for verifying manufacturer compliance before importing
• Distributors — due diligence obligations; cannot place products on the market if they know or should know they are unsafe
• Fulfilment service providers — new obligation; must implement systems to detect and remove unsafe products
• Online marketplace operators — must register on the EU Safety Gate portal, cooperate with market surveillance, and remove unsafe product listings

If you sell through Amazon, eBay, or any third-party platform, this last point has immediate practical implications for how your listings are structured and what documentation you must be able to supply.

---

Key Changes From the GPSD: What Is Actually Different?

1. The EU-Based Responsible Person Requirement

Under GPSR, products sold to EU consumers must have an economic operator established in the EU who holds the technical documentation and is the point of contact for market surveillance authorities. This mirrors the requirement introduced by the Medical Devices Regulation and is a significant change for non-EU manufacturers selling directly to European consumers — including via their own e-commerce websites.

If your business is based outside the EU, you need either an EU-based authorised representative, an EU importer, or an EU-based fulfilment service provider who accepts this responsibility in writing.

2. Traceability and Labelling Requirements

GPSR introduces mandatory traceability obligations. Products must bear:

• The manufacturer’s name, registered trade name or trademark, and postal address (or a single website address where this information is accessible)
• A product type, batch, or serial number, or other identifier
• Any warnings or safety information in the language(s) of the Member State where the product is sold

For small products where labelling space is limited, this information may appear on the packaging or an accompanying document. QR codes and digital labelling are explicitly recognised as a valid means of providing traceability information — a practical update for compact consumer electronics and accessories.

3. Digital Products and Connected Devices

The GPSD predated the Internet of Things. GPSR does not. Under the new regulation, software and digital features that affect product safety are explicitly within scope. If a firmware update could introduce a safety issue, or if a connected feature creates a risk that was not present at the time of sale, this is a product safety concern under GPSR. Manufacturers of connected consumer products must now consider the entire foreseeable lifecycle — including software updates and changes to cloud-based functionality — as part of their safety assessment.

4. Online Sales Are Fully Covered

This is no longer a grey area. GPSR explicitly applies to products sold online, regardless of whether the seller or marketplace is established inside or outside the EU. Online marketplaces must:

• Ensure economic operators can register and provide safety information on their platform
• Create a single point of contact for market surveillance authorities
• Register on the Safety Gate Rapid Alert System portal
• Implement measures to detect unsafe products and remove listings promptly

For manufacturers and importers selling through online channels, this means your documentation must be ready to be shared with both the platform and the relevant authority on short notice.

5. Internal Accident Reporting

GPSR introduces a new internal complaint and accident reporting obligation. Economic operators must:

• Keep a register of complaints relating to product safety
• Investigate reported accidents involving their products
• Report to market surveillance authorities within two working days if they become aware of a serious risk

This is a formal, documented process — not an informal notification. SMEs will need to set up a basic but functional system for logging and responding to safety-related reports.

---

Step-by-Step Compliance Approach for SMEs

Step 1: Determine Whether GPSR Applies to Your Product

Map your product against existing sector-specific legislation. If your product has a CE mark and all safety aspects are covered by the relevant directive(s), your GPSR exposure may be limited. If there are any residual safety aspects not addressed by sector legislation, GPSR fills those gaps. If your product has no sector-specific directive, GPSR is your primary framework.

Step 2: Conduct or Update Your Safety Assessment

Under GPSR, your safety assessment must be proportionate to the nature of the product and the risks it presents. Relevant factors include:

• Product characteristics (materials, composition, design, packaging)
• Effect on other products it will reasonably be used with
• Presentation and instructions
• Categories of consumers who will use the product, with particular attention to vulnerable consumers including children and the elderly

Where harmonised European standards exist and are referenced under GPSR, conforming to those standards creates a presumption of safety. Check the Official Journal of the EU for GPSR-referenced standards. Relevant standards may include EN ISO 31000 (risk management principles) and product-specific standards from CEN and CENELEC.

Step 3: Prepare Your Technical Documentation

Unlike CE marking directives, GPSR does not require a formal Declaration of Conformity in most cases. However, you must be able to demonstrate safety. Maintain a technical file including:

• Description of the product and its intended use
• Safety assessment
• Test reports (internal or third-party)
• List of standards applied
• Samples, photographs, or drawings as applicable

This documentation must be available to market surveillance authorities on request — typically within 3 to 10 working days depending on the authority.

Step 4: Verify Your Labelling and Traceability

Review every product and its packaging against the GPSR traceability requirements. Create a compliance checklist for each SKU covering manufacturer identification, product identification, and safety information in the correct languages. If you use QR codes, ensure the linked page is stable, maintained, and presents the required information clearly.

Step 5: Register on Safety Gate (If You Are an Online Marketplace or Operator)

If you operate an online marketplace, register on the Safety Business Gateway at ec.europa.eu/safety-gate. Manufacturers and distributors should ensure their marketplace partners have done so and understand your obligations to supply documentation if requested.

Step 6: Implement a Complaints and Accident Register

Set up a documented system — this can be a simple spreadsheet or basic CRM process — to log product safety complaints and any reported accidents. Define internal escalation paths and assign a responsible person for monitoring and reporting to authorities where required.

---

Common Mistakes to Avoid

Assuming CE marking is enough. CE marking demonstrates conformity with specific directives. It does not automatically satisfy GPSR where residual risks exist outside the scope of that directive. The two frameworks can and do coexist.

Ignoring the responsible person requirement for non-EU manufacturers. If your manufacturing is based in China, the US, or elsewhere and you sell directly to EU consumers via your own website, you need an EU-based economic operator in the chain. This is an enforcement priority.

Treating online sales as a lower-risk channel. GPSR explicitly closes previous gaps for e-commerce. Market surveillance authorities are increasing their monitoring of online platforms.

Failing to plan for software and firmware updates. If your product is connected, a post-sale update that introduces a safety issue is your liability. Establish a process for evaluating the safety implications of software changes before deployment.

Inadequate consumer-facing safety information. Warnings and safety instructions must be in the language of the Member State where the product is sold. Providing only English language instructions for products sold across the EU is non-compliant.

No documented complaint and accident handling process. The two-working-day notification requirement for serious risks is tight. If you do not have a process in place, you will not meet it when it matters.

---

Frequently Asked Questions

Q: Does GPSR replace the need for CE marking?
No. CE marking under sector-specific directives (such as LVD, EMC Directive 2014/30/EU, or Toy Safety Directive 2009/48/EC) remains separate. GPSR operates alongside these frameworks and covers safety aspects not addressed by them. For products with no applicable CE marking directive, GPSR is the primary safety framework but does not require a CE mark.

Q: My product is sold on Amazon EU. Do I need to do anything differently?
Yes. Amazon, as an online marketplace, now has formal obligations under GPSR and will require economic operators to provide traceability information and documentation. You should ensure your product listings include the required manufacturer identification and that you have a responsible person established in the EU. Amazon has published its own GPSR compliance requirements for sellers — review these alongside the regulation itself.

Q: What is the penalty for non-compliance with GPSR?
Penalties are set at Member State level, so they vary across the EU. However, GPSR requires Member States to impose effective, proportionate, and dissuasive penalties. Serious violations can result in product recalls, market withdrawal orders, fines, and in some jurisdictions, criminal liability for individuals. Non-compliant product listings can also be removed from online platforms without prior notice.

Q: Are B2B products covered by GPSR?
GPSR primarily covers products supplied to consumers. However, if a product is made available to both consumers and professionals — or if it can be reasonably expected that consumers will access it — GPSR applies. Products exclusively for professional use with clear controls preventing consumer access may fall outside scope, but this must be assessed carefully.

Q: Do I need third-party testing to comply with GPSR?
Not necessarily. GPSR requires a proportionate safety assessment, not mandatory third-party certification. However, for higher-risk products, independent laboratory testing against relevant harmonised standards substantially strengthens your compliance position and creates a documented presumption of safety. For lower-risk products, a well-documented internal assessment may be sufficient.

---

Conclusion: Act Now, Not at the Next Audit

The General Product Safety Regulation 2024 is now in force. Market surveillance authorities across the EU are activating their enforcement powers, and online marketplaces are already requesting compliance documentation from sellers. Waiting until you receive a formal challenge is the most expensive approach — both financially and in terms of business continuity risk.

The practical to-do list is manageable: assess your GPSR scope, update your technical documentation, check your labelling, confirm your EU responsible person arrangement, and put a complaint handling process in place. None of these steps are technically complex — but they do require structured attention and accurate knowledge of what the regulation actually requires.

---

Save Time and Reduce Risk With the CE Marking Compliance Kit

If you want to move through GPSR and CE marking compliance without building everything from scratch, the CE Marking Compliance Kit at gyuladancsi.gumroad.com/l/fhuox (€97) is worth a look. It includes ready-to-use technical file templates, Declaration of Conformity documents, risk assessment frameworks, and compliance checklists covering the major EU directives — all structured so that engineers and SME product teams can work through them without needing to hire a consultant for every step. For teams managing multiple product lines or approaching their first CE marking exercise, the time saving over building these documents from scratch is substantial.

→ Need a ready-to-use EU Declaration of Conformity? Download the EU Declaration of Conformity Pack 2026 — 5 directive-specific templates (EMC, LVD, Machinery, RoHS, RED), field-by-field completion guide, and harmonised standards reference. €67, instant download.