- Primary legal source for Member State penalty rules, market-surveillance corrective action, formal non-compliance, technical documentation, EU declarations, and retention duties.
- Article 42 is the Directive-level source for Member State penalty rules and the effective, proportionate, and dissuasive standard.
- Articles 38 and 39 set out the market-surveillance evaluation, corrective-action, withdrawal, recall, and Union safeguard procedure for apparatus presenting a risk.
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- Article 40 lists formal non-compliance findings and the restrictions, prohibition, recall, or withdrawal measures if they persist.
- Articles 7 and 9 and Annex II ground the technical-documentation, EU declaration, 10-year retention, importer-access, and EMC assessment evidence points.
"The penalties provided for shall be effective, proportionate and dissuasive."
More quoted passages
"Such rules may include criminal penalties for serious infringements."
"The economic operator shall ensure that all appropriate corrective action is taken"
"technical documentation is either not available or not complete"
"keep the technical documentation and the EU declaration of conformity for 10 years"