Just because a product has been tested against a harmonised standard doesn’t mean it will always work as intended. Risks in radio equipment often relate to degraded functionality – for example, interference from other wireless systems or connected devices nearby, uncommon usage scenarios, or environmental changes over time. As digital products become more connected, interactive, and configurable, following a standard is no longer enough to ensure that the product will function reliably when placed on the market.

Risk assessment is a crucial complement to European standards in the field of information and communication technologies (ICT). ETSI’s report TR 103 879 helps companies developing connected products take control.

Article in brief

This article explains why risk assessment is essential, not just to meet legal obligations, but to ensure performance in real-world use of digital technologies. It outlines how those developing connected products can identify and mitigate radio spectrum-related risks that could otherwise affect performance, compatibility, or the user experience – both at launch and throughout the product’s lifecycle. It also explains why this is a requirement under the Radio Equipment Directive (RED), highlights common pitfalls, and shows how risk assessment can support the product development process. You’ll also find a downloadable checklist.

An everyday example of an invisible problem

Imagine you’re listening to music in your kitchen using a wireless Bluetooth speaker connected to your phone. Everything works perfectly—until you turn on the microwave. Suddenly, the sound drops. The speaker disconnects, lags, or freezes.

This isn’t science fiction—it’s a real-world scenario. And the product was almost certainly tested and approved in line with the relevant standard.

The issue isn’t that someone made a mistake—it’s that the standard didn’t account for this specific combination of environment, usage, and technology. The speaker was tested in a lab, not in a household surrounded by other potential sources of interference.

This is exactly where risk assessment becomes essential.

Three reasons why harmonised standards sometimes fall short

1. Innovation outpaces standardisation

Developing standards takes time, sometimes years. Meanwhile, new generations of products, features, and configurations reach the market. A new kind of IoT device or multimodal communication solution may be launched before a relevant standard has even been finalised.

Relying solely on existing standards can therefore mean missing risks related to the most innovative aspects of a product.

2. Standards cover typical use cases – not real-world complexity

Standards are written to address the “normal case”. They define test methods for Wi-Fi or Bluetooth, but not how these technologies interact, or how they perform in homes or public spaces with multiple wireless devices, thick walls, and fluctuating temperatures.

ETSI’s TR 103 879 report highlights a clear example: a product with multiple radio interfaces (e.g. Wi-Fi + LTE) may be tested for each function separately. But the standard doesn’t say anything about how they operate simultaneously—which is often how the user actually uses them.

3. Products evolve after launch

Modern products are not static. They receive software updates, added features, and are used in new combinations. Standards test a product at a specific point in time—but the risk of interference can change throughout its lifecycle.

A well-executed risk assessment accounts for the entire lifecycle—including what happens after the initial release.

Read also: How ICT standardisation works in Europe

ETSI TR 103 879 – A guide to practical risk assessment

To manage the risks that standards don’t capture, ETSI’s TR 103 879 report offers practical guidance. It’s written to help manufacturers understand what to assess, how to do it, and why risk assessment matters in relation to European ICT standards.

In short, the document explains that:

• Risk assessment isn’t optional—it’s a legal requirement under the EU Radio Equipment Directive (RED).
• Even if a harmonised standard is applied, companies developing connected products must still check for residual risks not covered by the standard.
• The assessment should consider the entire product lifecycle—not just the production phase, but also software updates, changes in use, and combinations with other technologies.

The report provides concrete examples of where standards stop and risk assessment starts. A clear case is multimode equipment—products that include multiple radio interfaces (such as Wi-Fi, Bluetooth, and 5G). These may be tested according to separate standards, but the combined effects—commonly encountered in real use—are the manufacturer’s responsibility to evaluate and document.

Read the full report: ETSI TR 103 879 V1.1.1 (PDF)

Turning Risk Assessment into a Strength in Product Development

Bettina Funk frequently highlights how practical risk assessment can serve as a strategic tool in product development:

“Harmonised standards are a cornerstone of our system, but they only cover part of the picture when it comes to developing digital technologies. It’s only when we complement them with practical risk assessment that we begin to reflect reality – actual use, real environments, and combinations of functions and technologies.”

– Bettina Funk, CEO of the Swedish Information and Telecommunications Standardisation (ITS)

As the report emphasises, it is the manufacturer’s responsibility to identify risks that standards don’t cover. While harmonised standards provide a presumption of conformity with essential requirements, they are not a guarantee that all risks are managed. ETSI refers to the Blue Guide, which clearly states that even if a standard is applied in full, manufacturers must conduct their own analysis. There may be risks that were not addressed in the standard, or new use cases that were not foreseen during its development.

In other words: risk assessment is not about duplicating the standard – it’s about complementing it and bridging the gaps that emerge when technology moves faster than regulation.

Want a clearer view of what should be included in a documented risk assessment according to ETSI’s guidance?

Download: Risk Assessment Checklist

Risk assessment as part of professional product development

Harmonised standards are important, but they do not relieve the manufacturer of the responsibility to identify and manage additional risks. In today’s fast-moving technology landscape, it’s not uncommon for a product to meet formal requirements but still cause interference or lose functionality in real-world use.

This is precisely why risk assessment plays such a crucial role. It’s not an administrative burden—it’s a technical tool that ensures products work as intended: in the right environment, with the right user, and in the right combinations.

ETSI’s TR 103 879 report is a hands-on support tool. It helps companies understand the questions they need to ask, what to document, and how to demonstrate responsibility for aspects beyond the reach of the standard.

Interested in how ITS works with risk assessment, radio spectrum, and electromagnetic compatibility?

Explore our working groups or get in touch with us directly.