CRA, NIS2 and IEC 62443 screening

A quick applicability check for your product.

What best describes your product?

Which description fits its CRA scope?

Medical/IVD devices covered by MDR/IVDR are excluded. Health-sector use alone is not an exclusion. Open source alone is not an exemption.

Is the product made available on the EU market?

Can it exchange data with another device or network?

Include intended or reasonably foreseeable connections through other systems.

Does your organization provide services or carry out activities in the EU?

This is separate from where this particular product is sold.

What is your organization’s size under EU SME rules?

Use staff and financial thresholds, including partner/linked enterprises; headcount alone is not enough.

Which activity does your own organization perform?

Choose your own activity, not your customers’ sector. Other activities can also be covered by NIS2.

Is the product intended for industrial automation or control systems?

Consider its intended use, including use by your customers, in any sector.

Results

Initial screening, not a compliance determination. Reviewed 14 October 2026.

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