Article 32Conformity assessment procedures for products with digital elements

1. The manufacturer shall perform a conformity assessment of the product with digital elements and the processes put in place by the manufacturer to determine whether the essential cybersecurity requirements set out in Annex I are met. The manufacturer shall demonstrate conformity with the essential cybersecurity requirements by using any of the following procedures:

(a)

the internal control procedure (based on module A) set out in Annex VIII;

(b)

the EU-type examination procedure (based on module B) set out in Annex VIII followed by conformity to EU-type based on internal production control (based on module C) set out in Annex VIII;

(c)

a conformity assessment based on full quality assurance (based on module H) set out in Annex VIII; or

(d)

where available and applicable, a European cybersecurity certification scheme pursuant to Article 27(9).

2. Where, in assessing the compliance of an important product with digital elements that falls under class I as set out in Annex III and the processes put in place by its manufacturer with the essential cybersecurity requirements set out in Annex I, the manufacturer has not applied or has applied only in part harmonised standards, common specifications or European cybersecurity certification schemes at assurance level at least ‘substantial’ as referred to in Article 27, or where such harmonised standards, common specifications or European cybersecurity certification schemes do not exist, the product with digital elements concerned and the processes put in place by the manufacturer shall be submitted with regard to those essential cybersecurity requirements to either of the following procedures:

(a)

the EU-type examination procedure (based on module B) set out in Annex VIII followed by conformity to EU-type based on internal production control (based on module C) set out in Annex VIII; or

(b)

a conformity assessment based on full quality assurance (based on module H) set out in Annex VIII.

The article continues in the official text.