Conformity assessment procedure: internal production control

Annex IV (1): Internal production control

manufacturer · subject kind product · Annex IV (1)

Internal production control Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4 of this Annex, and ensures and declares on its sole responsibility that the product concerned satisfy the appropriate requirements of this Directive.

How to satisfy it: Module A, internal production control. The manufacturer declares on its own responsibility; this Directive designates no notified body.

Annex IV (1) on EUR-Lex · as of 2026-08-14 · Directive (EU) 2019/882

Annex IV (2): Technical documentation

manufacturer · subject kind product · Annex IV (2)

Technical documentation The manufacturer shall establish the technical documentation. The technical documentation shall make it possible to assess the conformity of the product to the relevant accessibility requirements referred to in Article 4 and, in case the manufacturer relied on Article 14, to demonstrate that relevant accessibility requirements would introduce a fundamental alteration or impose a disproportionate burden. The technical documentation shall specify only the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product. The technical documentation shall, wherever applicable, contain at least the following elements:

How to satisfy it: Where Article 14 was relied on, the technical documentation must DEMONSTRATE the fundamental alteration or disproportionate burden, not merely assert it.

Annex IV (2) on EUR-Lex · as of 2026-08-14 · Directive (EU) 2019/882

Annex IV (2)(a)

manufacturer · subject kind product · Annex IV (2)(a)

a general description of the product;

Annex IV (2)(a) on EUR-Lex · as of 2026-08-14 · Directive (EU) 2019/882

Annex IV (2)(b)

manufacturer · subject kind product · Annex IV (2)(b)

a list of the harmonised standards and technical specifications the references of which have been published in the Official Journal of the European Union , applied in full or in part, and descriptions of the solutions adopted to meet the relevant accessibility requirements referred to in Article 4 where those harmonised standards or technical specifications have not been applied; in the event of partly applied harmonised standards or technical specifications, the technical documentation shall specify the parts which have been applied.

How to satisfy it: Conditional on references published in the Official Journal. None is published under this Directive, so this route is unavailable today.

Annex IV (2)(b) on EUR-Lex · as of 2026-08-14 · Directive (EU) 2019/882

Annex IV (3): Manufacturing

manufacturer · subject kind product · Annex IV (3)

Manufacturing The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the products with the technical documentation referred to in point 2 of this Annex and with the accessibility requirements of this Directive.

Annex IV (3) on EUR-Lex · as of 2026-08-14 · Directive (EU) 2019/882

Annex IV (4): CE marking and EU declaration of conformity

manufacturer · subject kind product · Annex IV (4)

CE marking and EU declaration of conformity

How to satisfy it: CE marking and the declaration are one point of the procedure, not two separate duties.

Annex IV (4) on EUR-Lex · as of 2026-08-14 · Directive (EU) 2019/882

Annex IV (4.1)

manufacturer · subject kind product · Annex IV (4.1)

The manufacturer shall affix the CE marking referred to in this Directive to each individual product that satisfies the applicable requirements of this Directive.

Annex IV (4.1) on EUR-Lex · as of 2026-08-14 · Directive (EU) 2019/882

Annex IV (4.2)

manufacturer · subject kind product · Annex IV (4.2)

The manufacturer shall draw up a written EU declaration of conformity for a product model. The EU declaration of conformity shall identify the product for which it has been drawn up. A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

Annex IV (4.2) on EUR-Lex · as of 2026-08-14 · Directive (EU) 2019/882

Annex IV (5): Authorised representative

manufacturer · subject kind product · Annex IV (5)

Authorised representative The manufacturer’s obligations set out in point 4 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.

Annex IV (5) on EUR-Lex · as of 2026-08-14 · Directive (EU) 2019/882