Article 32 — Conformity assessment procedures for products with digital elements

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:

1. (a)

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

2. (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;

3. (c)

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

4. (d)

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

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:

1. (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

2. (b)

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

Where the product is an important product with digital elements that falls under class II as set out in Annex III, the manufacturer shall demonstrate conformity with the essential cybersecurity requirements set out in Annex I by using any of the following procedures:

1. (a)

   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;

2. (b)

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

3. (c)

   where available and applicable, a European cybersecurity certification scheme pursuant to Article 27(9) of this Regulation at assurance level at least ‘substantial’ pursuant to Regulation (EU) 2019/881.

Critical products with digital elements listed in Annex IV shall demonstrate conformity with the essential cybersecurity requirements set out in Annex I by using one of the following procedures:

1. (a)

   a European cybersecurity certification scheme in accordance with Article 8(1); or

2. (b)

   where the conditions in Article 8(1) are not met, any of the procedures referred to in paragraph 3 of this Article.

Manufacturers of products with digital elements qualifying as free and open-source software, which fall under the categories set out in Annex III, shall be able to demonstrate conformity with the essential cybersecurity requirements set out in Annex I by using one of the procedures referred to in paragraph 1 of this Article, provided that the technical documentation referred to in Article 31 is made available to the public at the time of the placing on the market of those products.

Manufacturers of products with digital elements that are classified as EHR systems under Regulation (EU) 2025/327 of the European Parliament and of the Council^(*) shall demonstrate conformity with the essential requirements set out in Annex I to this Regulation using the relevant conformity assessment procedure provided for in Chapter III of Regulation (EU) 2025/327.

The specific interests and needs of microenterprises and small and medium-sized enterprises, including start-ups, shall be taken into account when setting the fees for conformity assessment procedures and those fees shall be reduced proportionately to their specific interests and needs.