Risk Assessment
What is a Risk Assessment (Product Safety)?
A risk assessment is the process by which a manufacturer identifies, evaluates, and addresses potential hazards associated with a product to ensure it is safe for its intended use. Under EU product safety legislation, including Regulation (EU) 2023/988 (GPSR), carrying out and documenting a risk assessment is a core obligation for manufacturers placing consumer products on the EU market.
Why It Matters
A risk assessment is the foundation of a manufacturer’s product safety compliance. It provides documented evidence that potential hazards have been identified and that appropriate measures have been taken to eliminate or minimise risk before a product reaches consumers.
For market surveillance authorities, a risk assessment is one of the first documents requested during an investigation or compliance check. Without a thorough and documented assessment, manufacturers may be unable to demonstrate that their product meets EU safety requirements — leaving them exposed to enforcement action, product recalls, or market bans.
For ecommerce sellers, manufacturers, and brand owners, conducting a proper risk assessment is an essential step in meeting EU regulatory obligations and protecting both consumers and their business.
Key Requirements
Who Is Required to Carry Out a Risk Assessment?
A product safety risk assessment is required primarily from:
- Manufacturers placing consumer products on the EU market
- EU Authorised Representatives or Responsible Persons who hold or verify technical documentation on behalf of non-EU manufacturers
This requirement applies under:
- Regulation (EU) 2023/988 – General Product Safety Regulation (GPSR)
- Regulation (EU) 2017/745 – EU Medical Device Regulation (MDR)
- Other CE marking directives and sector-specific EU regulations
The depth and format of the risk assessment will vary depending on the product category and applicable regulation.
Responsibilities Relating to Risk Assessment
While specific obligations vary by regulation and role in the supply chain, responsibilities commonly include:
- Identifying all foreseeable hazards associated with the product and its intended use
- Evaluating the likelihood and severity of potential harm to consumers
- Documenting the measures taken to eliminate or reduce identified risks
- Ensuring the risk assessment is kept up to date if the product is modified
- Making the risk assessment available to market surveillance authorities upon request
- Incorporating risk assessment findings into the product’s technical documentation
Risk Assessment and Technical Documentation
A risk assessment does not stand alone. It forms a core part of a manufacturer’s technical documentation. Together, these records provide authorities with a complete picture of how a product was designed, tested, and determined to be safe.
Where a non-EU manufacturer has appointed an EU Authorised Representative or Responsible Person, that representative may be required to hold or have access to the risk assessment as part of their compliance responsibilities.
Need GPSR compliance support?
Euverify provides EU Authorised Representative services for manufacturers and ecommerce sellers placing products on the EU market. Our team supports documentation review, regulatory communication, and ongoing compliance management.
