Luca BertonThe CRA's conformity assessment requirements depend on your product's classification. Getting this right is critical — using the wrong assessment path means your CE marking is invalid and your product cannot legally be sold in the EU.
Default Category — Self-Assessment
For the majority of products (~90%), manufacturers can perform an internal conformity assessment. This means:
- Evaluating the product against CRA essential requirements
- Compiling a technical file documenting compliance
- Drafting an EU Declaration of Conformity
- Applying the CE marking
Important Class I — Standards or Third-Party
For Class I products, you have two paths:
- Option A: Apply harmonized standards (when available) and self-assess
- Option B: Engage a notified body for third-party assessment
The harmonized standards being developed by ETSI are crucial here — once published, they unlock the self-assessment path for Important Class I products.
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View on Amazon →Important Class II — Mandatory Third-Party
No self-assessment option. You must engage an accredited notified body to perform the conformity assessment. This includes type examination and production quality assurance.
Critical — European Certification
The highest level. Products must obtain a European cybersecurity certificate under an EU certification scheme. These schemes are being developed under the Cybersecurity Act (Regulation 2019/881).
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Start on Pluralsight →Cost Implications
Third-party assessments typically cost €20,000–€100,000+ depending on product complexity. Budget for this in your product development cycle — it's no longer optional.