Self-assessment vs notified body: why most products skip the lab
The CRA lets the majority of manufacturers assess their own products. Here is who can, who cannot, and what self-assessment actually involves.
One of the most expensive misunderstandings about the CRA is that compliance means hiring a lab. For most products, it does not. The regulation is built to let manufacturers assess their own products, and it expects them to.
The three buckets
Your conformity route depends on how your product classifies. There are three broad buckets.
- Default category: products not named as important or critical. These can be self-assessed by the manufacturer. Most products land here.
- Important products (Annex III): split into two classes. The lower class can self-assess when harmonised standards are applied, and otherwise leans toward a third party. The higher class involves a notified body.
- Critical products: the highest-risk categories, subject to the strictest requirements, which can include mandatory third-party assessment or certification.
About 90% of products fall into the default category or the self-assessable part of the important list. That is why most manufacturers can comply without a notified body.
What self-assessment actually is
Self-assessment is not a lighter obligation. It is documentation work you do yourself instead of paying someone else to watch you do it. In practice it means: confirm your classification, run the mandatory risk assessment, work through the Annex I essential requirements and show how your product meets each one, capture the evidence (including an SBOM and vulnerability screening), and produce the technical file and Declaration of Conformity.
The reason a lab costs tens of thousands per product is not that the work is exotic. It is that the standards are written for assessors and you are paying someone to interpret them. Software that translates the requirements into plain language and captures the evidence for you does the same job for a fraction of the cost.
Not sure which bucket your product is in? The classification is the first thing our free check gives you, along with the conformity route it implies.