Annex I to VI
Annex IV: Conformity assessment
Internal production control: technical documentation, manufacturing control, CE marking and a written EU declaration for each product model.
- Citation
- Annex IV, CELEX 32019L0882 (Directive)
- Binds
- Manufacturers, and authorised representatives where the mandate covers the declaration and marking steps.
- In the instrument
- Annex I to VI
- Applies from
- 28 June 2025 for products placed and services provided from that date (Article 31(2)). The Article 4(8) 112 duty may be deferred to 28 June 2027 where a member state uses Article 31(3).
- Source
- EUR-Lex, CELEX 32019L0882
What it requires
Annex IV sets the internal production control procedure. The manufacturer fulfils points 2, 3 and 4 and declares on its own responsibility that the product meets the applicable requirements.
Point 2 requires technical documentation that lets a reviewer assess conformity with the Article 4 requirements and, where Article 14 is relied on, demonstrate that a requirement would cause a fundamental alteration or a disproportionate burden. It must address only the requirements that apply, and say as much as is needed about design, manufacture and operation. At a minimum it must contain an outline of the product and a list of the standards and specifications used, whether in full or in part, with a description of the solutions adopted where those standards were not applied and the parts applied where application was partial.
Point 3 requires the manufacturer to do what is needed so that production, and the checks on it, keep the product in line with the technical documentation and the requirements. Point 4 requires CE marking on each individual product that satisfies the requirements and a written EU declaration for each product model, identifying the product, with a copy available to authorities on request. Point 5 allows the authorised representative to carry out the point 4 obligations where the mandate says so.
What to do
- Write the technical documentation before the first placing on the market.
- List the standards applied, the parts applied and the solutions used where they were not.
- Include the Article 14 assessment in the file where the exception is relied on.
- Control the manufacturing process against the documented design.
- Affix CE marking per unit and draw the declaration per model.
- Keep the file for five years under Article 7(3).
Evidence to keep
- The technical documentation with the two required elements and the design record.
- The manufacturing control and monitoring records.
- The declaration per model and the CE marking record per unit.
- The Article 14 assessment where used.
Dates
- 2025-06-28The procedure applies to products placed from this date. (Article 7(2), Article 31(2))
Cross-references
Where teams get this wrong
The file has to be understandable to a reviewer who was not in the design team. A folder of test reports without the general description and the standards gap analysis is not the documentation the annex describes.
Read from the Official Journal text of Directive (EU) 2019/882, OJ L 151/70, 7 June 2019, Annex IV. Check it yourself: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019L0882. This page states the provision in our own words and is not legal advice; it does not certify any product or service.