Is a Risk Assessment mandatory?

Yes, a risk assessment is mandatory under the General Product Safety Regulation (GPSR).

According to Article 9(2) of the regulation, before placing any consumer product on the EU market, manufacturers must carry out an internal risk analysis and document it. This documented risk analysis forms a baseline requirement of your product’s “technical documentation,” which must be kept on file and made available to market surveillance authorities or e-commerce platforms upon request.

What the GPSR Risk Assessment Must Cover:

When evaluating product safety under Article 6, you must analyze a modern, broad scope of criteria:

• Physical Characteristics: Product design, technical features, material composition, assembly instructions, and packaging.
• Target Audience: The risks to vulnerable consumers, specifically considering children, the elderly, or specific age grading.
• Foreseeable Misuse: Safety risks arising not just from normal intended use, but also from predictable, incorrect use by consumers.
• Product Interaction: How the item behaves when used together with other products (e.g., connected hardware).
• New Digital Threats: If the product is a smart device, the risk assessment must explicitly account for cybersecurity features, software updates, and any predictive or artificial intelligence (AI) functionalities.

Sector-Specific vs. Non-Harmonized Goods:

• If your product is already regulated (e.g., CE-marked toys, electronics, or medical devices): The extensive risk analysis required by those specific EU directives usually covers your GPSR obligations. You simply integrate them.
• If your product is non-harmonized (e.g., furniture, clothing, or home decor): You previously might not have needed a formal safety file. Under the GPSR, creating and holding this documented risk analysis is now a strict legal baseline requirement.