Chapter VIII, market surveillance of products and Union safeguard procedure
Article 22: Formal non-compliance
Missing or incorrect CE marking, declaration, technical file or identification information is formal non-compliance, and persistent failure leads to restriction or withdrawal.
- Citation
- Article 22, CELEX 32019L0882 (Directive)
- Binds
- Economic operators that have the paperwork or marking wrong even where the product may be accessible.
- In the instrument
- Chapter VIII, market surveillance of products and Union safeguard procedure
- 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
Paragraph 1 lists the findings that count as formal non-compliance: CE marking affixed in breach of the regulation or Article 18; CE marking not affixed; no EU declaration; an incorrect declaration; technical documentation unavailable or incomplete; the identification information in Article 7(6) or Article 9(4) absent, false or incomplete; or any other administrative requirement in Article 7 or 9 not met.
Where a member state makes such a finding, it requires the operator to end the non-compliance. Paragraph 2 applies if the failure persists: the member state takes appropriate measures to restrict or prohibit making the product available, or to ensure it is withdrawn.
The article is a reminder that an accessible product can still fail on the file. Authorities do not have to prove a usability defect to act on a missing declaration or an incomplete technical file.
In practice
Run a formal-compliance audit once a year with a simple checklist: declaration present and correct, CE marking present and correctly placed, technical file complete, manufacturer and importer identification present and accurate, instructions in the right language. Each no is a finding with an owner and a date. The audit is cheap compared with a formal non-compliance procedure.
What to do
- Audit the declaration, marking, file and identification data as a set.
- Correct a formal defect before the authority escalates.
- Record the correction and the date it was completed.
Evidence to keep
- A formal compliance checklist per model.
- The corrected declaration, mark or identification artwork.
- The authority correspondence showing closure.
Dates
- 2025-06-28Formal duties apply to products placed from this date. (Article 31(2))
Cross-references
Where teams get this wrong
The most common formal defect is an incomplete technical file that names a standard without the parts applied or the alternative solutions. That is enough for a formal finding even if the product works well.
Read from the Official Journal text of Directive (EU) 2019/882, OJ L 151/70, 7 June 2019, Article 22. 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.