Default category
Machine controllers, sensors, ERP software, apps: by far the largest share of products falls into the default category. That spares you the notified body, not the obligations.
A product in the default category is any product with digital elements that is neither an important product under Annex III nor a critical product under Annex IV. The manufacturer may assess conformity itself, without a notified body.
Definition in the Regulation
The Regulation does not use the term; it defines the category by exclusion. Article 7(1) classifies products with the core functionality of an Annex III category as important products, and Article 8 refers to Annex IV for critical products. Everything else is in the default category. For these products, Article 32(1) offers a choice of four procedures: internal control under module A (point (a)), EU-type examination followed by conformity to EU-type (modules B and C), full quality assurance (module H) or a European cybersecurity certification scheme. Under module A, as set out in Annex VIII, Part I, the manufacturer draws up the technical documentation, carries out the assessment itself, draws up the EU declaration of conformity and affixes the CE marking.
Under Article 7(1), what counts is the product's core functionality, not a component it contains: a machine with a built-in operating system is not an operating system and remains in the default category.
What it means for manufacturers
From 11 December 2027, a product in the default category must meet all the requirements of Annex I, with a risk assessment, technical documentation, an SBOM, a support period and the CE marking; the reporting obligation under Article 14 has applied since 11 September 2026. Only the third-party assessment falls away. As no harmonised standard has been published in the Official Journal as of October 2026, the manufacturer has to describe and justify its solutions itself under Annex VII, point (5). Under Article 13(22), market surveillance authorities can ask for this justification on a reasoned request.
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- Important product, class I
- Important product, class II
- Critical product
- Conformity assessment
- CE marking