Homologation: Why certification determines market success or failure

The challenge: complexity underestimated

• Automotive: ISO 26262 (functional safety), ISO 21434 (cybersecurity), ISO 14001 (environmental management)
• Medical technology: IEC 62304, ISO 13485, CE labeling

The problem: Project teams focus on product development and treat homologation as a downstream step. This can lead to delays, additional costs, and, in the worst case, rejection by the certification body.

The consequences of inadequate homologation: delays and loss of market access

Those who only address homologation requirements shortly before market entry risk significant project delays. Missing documentation, incomplete test reports, or a lack of traceability can result in products not being approved on time.

In highly regulated industries, this means competitive disadvantages, lost sales, and potential damage to reputation. Without valid certification, no product can be legally sold.

The solution: compliance as a competitive advantage

Successful companies integrate homologation into their product development right from the start. This means early analysis of regulatory requirements, systematic documentation, and close cooperation with experienced certification bodies. The homologation process comprises several phases:

1. Identification of target markets and regulatory requirements
2. Verification of design conformity
3. Selection of the certification authority
4. Testing in accordance with applicable standards
5. Submission of documentation
6. Audit and inspection of manufacturing processes
7. Granting of approval

This structured approach not only enables market access, but also builds trust among customers and partners.

Conclusion: Proactive rather than reactive

Homologation is not a bureaucratic obstacle, but a strategic success factor. Companies that tackle this process early and systematically shorten their time to market, avoid costly rework, and secure sustainable competitive advantages.

Sources

• United Nations Economic Commission for Europe (UNECE): World Forum for Harmonization of Vehicle Regulations (WP.29)
• IGAR: FAQ about UN ECE, WP.29 and harmonization
• ISO 26262: Road vehicles – Functional safety
• Ravizza A, De Maria C, Di Pietro L, Sternini F, Audenino AL and Bignardi C (2019) Comprehensive Review on Current and Future Regulatory Requirements on Wearable Sensors in Preclinical and Clinical Testing. Front. Bioeng. Biotechnol. 7:313. doi: 10.3389/fbioe.2019.00313