GPSR
Compliance
For Book
Publishers
-
Founder of Euverify | EU & UKCA Compliance Expert
Ajay is an eCommerce expert with 17+ years of experience as an Amazon, eBay, and Etsy seller and a Shopify specialist. He excels in EU and UK compliance, including GPSR and UKCA, helping businesses expand into European and UK markets. Ajay is the founder of Sweans, a London-based eCommerce agency, and Euverify.com, a SaaS platform streamlining compliance for non-EU sellers.
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Does Standalone Software Fall Under the EU GPSR? What Software Providers Must Know
If you develop or sell standalone software in the EU, your compliance obligations have already changed. Since 13 December 2024, the GPSR applies not only to physical goods, but also to certain types of standalone software where safety risks are foreseeable.
The European Commission has mentioned that standalone software may be considered a ‘product’ under the GPSR when it poses a risk to consumer health, safety, or security. Even if no physical device is involved. This change creates new responsibilities for developers, importers, and online platforms that distribute software to EU consumers.
In this blog, we’ll explain what the GPSR means for software providers and highlight key clarifications on its scope. We’ll also show how businesses, particularly those based outside the EU, can stay compliant with the help of an Authorised Representative.
Does the GPSR Apply to Standalone Software? Here’s What Counts
According to Article 2 of the General Product Safety Regulation (EU) 2023/988, the term “product” includes:
“any item, whether or not it is interconnected to other items, supplied or made available, whether for consideration or not, including in the context of providing a service, which is intended for consumers or is likely, under reasonably foreseeable conditions, to be used by consumers even if not intended for them.”
The European Commission has indicated through its Safety Gate Q&A that standalone software may fall under the GPSR when it presents consumer safety risks, unless it is specifically regulated under another law such as the MDR or RED. While the GPSR isn’t a “software regulation” in the traditional IT sense, it does apply to software from a product safety perspective.
What Types of Standalone Software Are Covered?
As clarified in Article 2, software may fall within scope when it is intended for, or foreseeably used by, consumers and could impact their health, safety, or security. This includes software offered independently of physical hardware, so long as it could present a safety risk.
Types of software likely to fall under GPSR include:
- Health and fitness apps (e.g., digital therapeutics, posture trackers, wellness tools)
- Smart home and IoT controllers (e.g., lighting, alarm, or thermostat apps)
- Parental control or child-monitoring apps
- Navigation and driving behavior software
- E-learning platforms designed for children
- Lifestyle and emotion tracking tools (if linked to wellbeing or safety outcomes, e.g., sleep, stress monitors)
- Games with VR or haptic feedback
This list is not exhaustive. However, if your software could influence a user’s physical safety, psychological wellbeing, or security (directly or through predictable misuse), it is likely covered under the GPSR.
Why Software Safety Now Matters Under Product Law
Standalone software, whether sold on a disc, downloaded from a website, or accessed through an app store, is now treated much like any other product when it comes to consumer safety. This is because software can pose very real risks, even if it is intangible. For example:
- Apps that interfere with hardware and trigger malfunctions
- Software updates that introduce bugs or security vulnerabilities
- Programs that cause physical or psychological harm through manipulative or addictive design
- Health and fitness apps that give misleading or unsafe advice
Regulators will consider both the intended use and any reasonably foreseeable misuse of the software when assessing safety risks. This means evaluating not only how developers intended it to be used, but also how consumers might realistically misuse it. EU enforcement authorities can assess both, making it essential for businesses to identify and document risks before putting software on the market.
Compliance Obligations for Software Developers
If your software is now considered a “product” under the GPSR, you’re expected to meet a set of responsibilities that go well beyond just coding and releasing updates. These obligations are designed to make sure consumers are safe, and they touch every stage of your product’s lifecycle.
Risk Assessment
You’ll need to assess and document any risks linked to both normal and foreseeable use of your software. This doesn’t just mean technical risks. It also includes potential impacts on physical safety, psychological well-being, and even harms that come from data misuse.
Technical Documentation
Regulators want clear proof that your software has been designed and tested with safety in mind. This means maintaining documentation that shows how risks were managed, what design safeguards were built in, and what testing or validation was carried out.
Consumer Instructions and Warnings
Your users must receive clear instructions and warnings in formats they can actually access and in the official language of the country you’re selling into. The GPSR links accessibility and clarity directly to safety compliance, so vague or poorly translated instructions are no longer acceptable.
Market Monitoring
Your obligations don’t end once the software is live. Developers are expected to monitor real-world performance, collect safety feedback, and act quickly if issues arise. That could mean releasing patches, rolling back updates, or in extreme cases, withdrawing the product.
Traceability
Finally, your software must be traceable. That means making sure your business details or those of your Authorised Representative are clearly available so consumers and regulators know who is responsible if something goes wrong.
What About Non-EU Companies? The Role of the Authorised Representative
If your company is based outside the EU but you distribute or make software available to EU consumers, you’re still legally required to comply with the GPSR. Since you don’t have a local presence, one of the most important steps you must take is appointing an Authorised Representative (AR).
An AR essentially acts as your business’s legal point of contact within the EU. Their responsibilities include:
- Acting as your local contact for authorities – making communication with regulators faster and smoother.
- Holding your technical documentation and Declaration of Conformity – so they’re always available during inspections.
- Supporting market surveillance – which may involve responding to safety alerts or coordinating corrective actions if problems arise.
- Ensuring your compliance documents are complete and up to date – reducing the risk of gaps that could trigger enforcement.
- Minimising delays or penalties – by ensuring regulators have what they need when they need it.
For non-EU businesses, appointing a reliable AR is not just a formality — it’s essential. Without one, you risk fines, blocked market access, or even product withdrawals. With the right AR, however, you maintain smoother access to the EU market and show regulators and customers that you take compliance seriously.
Real-World Scenario: How the Rules Apply
Let’s say a wellness startup in Canada develops a mental health app that provides cognitive therapy exercises. The app is distributed through the App Store and is available to users in several EU countries.
Even if free and software-only, this app is considered a ‘product’ under the GPSR because it is offered to consumers, impacts mental well-being, and introduces foreseeable safety risks.
- It’s intended for consumer use
- It directly impacts mental health and well-being
- It can create foreseeable risks through faulty advice, poor UX design, or unintended misuse
To stay compliant, the Canadian company would need to:
- Carry out a risk assessment that includes potential misuse and unintended effects
- Prepare a Declaration of Conformity and ensure it’s held by their Authorised Representative
- Appoint an EU-based AR to act as their legal contact and support compliance obligations
- Monitor post-market feedback and safety data from EU users, responding quickly to any risks
GPSR Compliance Checklist for Software Providers
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Use this list to assess your current readiness:
- Have you reviewed whether your software falls within GPSR scope?
- Have you completed a documented risk assessment?
- Are usage instructions and warnings accessible and in local languages?
- Do you have a mechanism for post-market safety monitoring?
- Have you designated an EU-based Authorised Representative?
- Is your technical file complete and stored properly?
- Is traceability information visible to EU consumers?
How the GPSR Relates to Other EU Regulations for Software
Depending on what your software does, the GPSR may overlap with other EU rules:
- Radio Equipment Directive (RED): Applies to software connected to wireless devices.
- Medical Device Regulation (MDR): Covers software with a medical or health purpose.
- AI Act (upcoming): Will regulate software that makes automated or algorithmic decisions.
- Cyber Resilience Act (CRA – proposed): Aims to ensure stronger cybersecurity for digital products.
Even if your software is covered by one of these laws, the GPSR can still apply as a complementary framework. In practice, this often means you’ll need to meet general consumer safety obligations under GPSR alongside sector-specific requirements — including the need for an Authorised Representative when selling into the EU.
Conclusion: Preparing for GPSR Compliance in the Software Industry
The inclusion of certain types of standalone software under the GPSR has widened the scope of product safety law. For software providers, especially those outside the EU, this brings new obligations: preparing safety documentation, carrying out risk assessments, and appointing an EU-based Authorised Representative.
Since the regulation is already in force, businesses should not delay. Taking action now helps protect market access, avoid enforcement issues, and ensure products remain safe for consumers. Whether you’re developing health, lifestyle, or connected software, GPSR compliance is a legal requirement, not just an option.
If your company needs support with compliance or representation in the EU, Euverify can guide you through the process and help ensure you meet your obligations under GPSR.
Practical Guide to Clothing, Apparels, and Textile Compliance in the UK & EU
A helpful guide that provides a comprehensive overview of compliance for Clothing, Apparels, and Textiles.
Technical Files Checklist & Risk Assessment Template
For Clothing, Apparels, and Textiles
- Ensure Compliance
- Reduce Risk
- Streamline Documentation
- Supports market access
Get it now for just £40!
Appoint Your EU Representative & Ensure Compliance for Your Clothing, Apparels, and Textile
- Stay compliant with EU regulations
- Hassle-free representation for Clothing, Apparels, and Textiles
Related Resources
Compliance
Guides & Tutorials
Cosmetics
Industry Insights
GPSR
Regulatory Framework
GDPR
Regulatory Framework
Cosmetics
Industry Insights
