Chapter III, obligations of economic operators dealing with products
Article 7: Obligations of manufacturers
Manufacturers must design to Annex I, build the Annex IV technical file, run the conformity procedure, draw up the EU declaration, affix CE, retain records for five years and act on non-conformity.
- Citation
- Article 7, CELEX 32019L0882 (Directive)
- Binds
- Any manufacturer, including a company that has a product made and markets it under its own name or trade mark.
- In the instrument
- Chapter III, obligations of economic operators dealing with products
- 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
Paragraphs 1 and 2 set the core product duty. A manufacturer placing a product on the market must ensure it was designed and manufactured to the applicable Annex I requirements, draw up the technical documentation in Annex IV, and carry out, or have carried out, the conformity assessment procedure in that annex. When the procedure shows conformity, the manufacturer draws up the EU declaration of conformity and affixes the CE marking.
Paragraph 3 sets a five-year retention period for the technical documentation and the declaration, counted from the day the product was placed on the market. Paragraph 4 requires procedures so that series production stays in conformity, with design changes and changes to harmonised standards or technical specifications taken into account.
Paragraphs 5 to 7 cover identification and communication: a batch, type or serial identifier, or an equivalent, on the product, or on the packaging or accompanying document where size or nature prevents it; the manufacturer's name and a single contact address; and instructions and the safety information in the language end users and authorities understand, clear and intelligible. Paragraph 8 requires corrective action and withdrawal where needed, immediate notice to the authorities, and a register of non-compliant products and complaints. Paragraph 9 requires cooperation with a reasoned authority request.
What to do
- Write the technical file to Annex IV before the first unit is placed.
- Run the Annex IV internal production control procedure and sign the declaration.
- Affix CE marking and keep the declaration and file for five years.
- Put series-production controls and a change-review procedure in place.
- Label the product and the packaging with identification and a single contact address.
- Keep a non-conformity and complaints register and act on it.
Evidence to keep
- The technical documentation, including the standards applied and the solutions adopted.
- The signed EU declaration of conformity and the CE marking artwork.
- The five-year retention index with the placing-on-market date for each model.
- The production control record and the change log.
- The non-conformity and complaints register.
Dates
- 2025-06-28Products placed on the market from this date must comply. (Article 2(1))
- 2030-06-28No general product transition exists; this date is the service transition, not a product extension. (Article 32(1))
Cross-references
Where teams get this wrong
The five years run from placing on the market, not from the design freeze. A model sold for six years needs a retention index that keeps each variant's file for five years after its own last placing.
Read from the Official Journal text of Directive (EU) 2019/882, OJ L 151/70, 7 June 2019, Article 7. 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.