The European market requires that all electronic products comply with essential safety, health and electromagnetic compatibility requirements before being placed on the market. These characteristics are guaranteed through the CE marking, which is not a simple administrative procedure, but rather confirmation that the product has passed the necessary tests and can be used without risk to people or interference with other equipment.
However, reality shows that many products still fail in this regard. The 2024 market surveillance campaign in Spain revealed numerous non-compliances in both testing and document analysis [1]. Beyond the figures, it is important to understand why these failures occur, how to avoid them from the design stage and what consequences they have for manufacturers.
Analysed products | Tested | Non-compliance tested | Documentary analysis | Non-compliance documentary analysis |
Low voltage | 44 | 26 |
87 |
68 |
EMC | 36 | 17 | ||
Eco-design | 31 | 25 |
Designing for compliance from the beginning of the design process
For electronic products, the most relevant tests are low voltage tests, regulated by Directive 2014/35/EU, and electromagnetic compatibility (EMC) tests, defined in Directive 2014/30/EU. The former ensure that there are no electrical risks to the user (electric shocks, leakage currents, insufficient insulation), while the latter ensure that the equipment does not generate interference or is vulnerable to external disturbances.
Experience shows that many of the faults detected in the laboratory are not accidental, but rather the result of design decisions that are not in line with regulations: from poor track routing or a lack of ground planes to the omission of real-world usage scenarios. To reduce risks, it is essential to apply the Design for Compliance approach and accompany it with pre-certification testing in the laboratory before proceeding to the official test.
Incidents resulting from failure to comply with these requirements are real. In hospitals, for example, there have been documented cases in which electromagnetic interference prevented critical equipment from functioning. In an ambulance, a patient died because radio emissions affected the monitor-defibrillator to which he was connected [4]. These events illustrate what is at stake when regulatory requirements are ignored.
Consequences of non-compliance
Non-compliance has consequences that go far beyond repeating a test. Common additional costs include prototype redesigns, launch date delays, logistics costs and even product recalls.
In addition, the competent authorities may impose financial penalties, marketing bans, public warnings or obligations to repair and replace products already sold. In Spain, the Industry Law and regional regulations establish specific penalty regimes, while at European level, Regulation (EU) 2019/1020 strengthens market surveillance and defines the responsibilities of manufacturers, importers and distributors.
The impact is not limited to the economic sphere: the manufacturer may be held liable for civil damages if its product causes material or personal injury, and may even face criminal liability in cases of gross negligence. All this is without forgetting the reputational damage to the company manufacturing the product, which often far exceeds the investment that would have been required to design the product in accordance with regulations from the outset.
Eco-design: the future of certification
Although eco-design is not yet mandatory for all electronic products, Directive 2009/125/EC, the new ESPR Regulation and European policies are increasingly promoting energy efficiency, durability, repairability, recyclability and the reduction of hazardous materials. Incorporating these criteria from the beginning of the design process avoids costly redesigns in the future and adds immediate differential value to the product.
Eco-design not only contributes to sustainability and waste reduction, but also improves brand image in an increasingly conscious market. At TEKHNĒ, we are ISO 14006 certified in eco-design and have experience in future compliance with the Digital Product Passport (DPP), setting the standard in the electronics sector and demonstrating our technical and socio-environmental commitment.
Conclusion
Regulatory compliance should not be seen as an obstacle, but rather as an essential component in ensuring user safety, product commercial viability and company reputation.
The key lies in integrating requirements from the outset of the design process, conducting pre-certification testing, taking care of technical documentation and considering eco-design as part of the strategy.
At TEKHNĒ, we accompany our clients throughout this process: from ideation and design to pre-certification testing, ensuring that products reach the market without the risk of non-compliance, penalties, or recalls.
If you would like to learn more about this topic, we invite you to read our post The importance of certifying electronic products – TEKHNĒ and download our free e-book How to Develop Quality Electronic Products – TEKHNĒ.
REFERENCES
[1] Campaña de vigilancia de mercado 2024
[2] Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
[3] Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility
[4] Electromagnetic Compatibility (EMC)
[5] Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products
[6] Market surveillance – European Commission
[7] Real Decreto Legislativo 1/2007, of 16 November 2007, which approves the revised text of the General Law for the Defence of Consumers and Users and other complementary laws
[8] Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energy-related products
[9] ESPR Regulation and Digital Product Passport, of the European Parliament and of the Council, of 13 June 2024, establishing a framework for setting eco-design requirements for sustainable products.
[10] ISO 14006 eco-design management
