Complete an internal risk analysis and technical documentation before placing on the market, kept for 10 years
Severity HighArt. 9(1)–(3)；Art. 5；Art. 7–8
Before placing a product on the market the manufacturer must carry out an internal risk analysis and draw up technical documentation containing at least a general description of the product and the essential characteristics relevant for assessing its safety. Where appropriate to the risks it must also contain an analysis of possible risks and the solutions adopted, including the outcome of tests conducted by or for the manufacturer, and the list of European standards or other elements applied. Where standards were only partly applied the parts applied must be identified. The documentation must be kept up to date and available to market surveillance authorities for 10 years.
- Applies when
- All manufacturers placing consumer products on the EU market, including Chinese OEMs and own-brand sellers.
- Evidence to retain
- · Internal risk analysis report
- · Technical documentation (product description, safety-relevant essential characteristics, risks and mitigations)
- · Third-party or in-house laboratory test reports
- · List of European standards applied, identifying clauses where only partly applied
- · Version control and 10-year retention record for the technical documentation
Estimated first-time effort: 8–25 person-days (estimate, not a commitment)
Appoint an EU-established responsible person and run the periodic checks
Severity CriticalArt. 16(1)–(3)；Regulation (EU) 2019/1020 Art. 4(3)
A product may only be placed on the market if an economic operator established in the Union is responsible for the tasks in Article 4(3) of Regulation (EU) 2019/1020. In addition, where appropriate to the risks, that responsible person must regularly check that the product conforms to the Article 9(2) technical documentation and meets the Article 9(5), (6) and (7) requirements on identification, manufacturer contact details and instructions/safety information, and must provide documented evidence of those checks on request. Its name, registered trade name or trade mark and postal and electronic contact details must appear on the product, its packaging, the parcel or an accompanying document.
- Applies when
- Chinese brand owners and cross-border e-commerce sellers without an EU entity; online marketplaces typically make this a listing precondition and require proof.
- Evidence to retain
- · Mandate or contract with the responsible person covering the Article 4(3) tasks
- · Artwork proof of the responsible person details on the product or packaging
- · Responsible person check-list and per-batch check records
- · Record of documented evidence provided to market surveillance authorities
Estimated first-time effort: 3–10 person-days (estimate, not a commitment)
Notify product accidents through the Safety Business Gateway without undue delay
Severity HighArt. 20(1)–(4)；Art. 27
The manufacturer must ensure that an accident caused by a product placed or made available on the market is notified through the Safety Business Gateway to the competent authorities of the Member State where the accident occurred, without undue delay from the moment it knows about it, stating at least the product type and identification number and the circumstances if known, and supplying further relevant information on request. Notifiable events are occurrences associated with use that resulted in death or in serious adverse effects on health and safety, permanent or temporary, including injuries, other bodily damage, illnesses and chronic health effects. Importers and distributors aware of an accident must inform the manufacturer without delay; where the manufacturer is not established in the Union, the Article 16 responsible person must ensure the notification is made.
- Applies when
- All manufacturers, importers, distributors and EU responsible persons supplying EU consumers; especially frequent for home robots, robotic mowers and battery-powered AI hardware.
- Evidence to retain
- · Accident intake and triage procedure with an internal deadline implementing "without undue delay"
- · Safety Business Gateway submission receipts and copies of the notifications
- · Accident investigation report and root-cause analysis
- · Channel and records for importers/distributors reporting accidents to the manufacturer
Estimated first-time effort: 4–12 person-days (estimate, not a commitment)
Corrective action, recall notice and minimum remedies for dangerous products
Severity CriticalArt. 9(8)；Art. 35；Art. 36；Art. 37
Where a manufacturer considers or has reason to believe that a product it placed on the market is dangerous it must immediately take the corrective measures needed to bring it into conformity, including withdrawal or recall as appropriate; inform consumers under Article 35 or 36 or both; and inform, through the Safety Business Gateway, the market surveillance authorities of the Member States where the product was made available, giving details of the risk and of any corrective measure taken and, where available, the quantity per Member State still circulating. Where product registration or loyalty systems allow consumers to be identified they must be contacted directly; where not all affected consumers can be reached, a clear and visible recall notice or safety warning must be disseminated through the widest possible channels including the company website and social media.
- Applies when
- All manufacturers, importers, distributors and providers of online marketplaces (the latter under Article 22(12)).
- Evidence to retain
- · Dangerousness determination and corrective action decision record with timestamps
- · Recall notice text and screenshots of the publication channels (website, social media, marketplaces)
- · List of affected consumers and direct contact records, including the basis for collecting safety-only contact details
- · Safety Business Gateway notifications and correspondence with authorities
- · Remedy execution ledger (repair, replacement, refund) and recall effectiveness statistics
Estimated first-time effort: 10–40 person-days (estimate, not a commitment)
Provide consumer complaint channels and maintain an internal complaints and recall register
Severity MediumArt. 9(11)–(13)
Manufacturers must make publicly available communication channels such as a telephone number, electronic address or a dedicated section of their website, taking accessibility needs into account, so that consumers can submit complaints and report accidents or safety issues. They must investigate complaints and accident information received and keep an internal register of those complaints, of product recalls and of any corrective measures taken. The register may store only the personal data necessary to investigate the complaint, kept no longer than necessary and in any event no more than five years from entry.
- Applies when
- All manufacturers supplying EU consumers; in practice this register is the first document requested in market surveillance checks and marketplace reviews.
- Evidence to retain
- · Public complaint channel page and accessibility statement
- · Internal register of complaints and accidents with investigation conclusions and closure status
- · Register entries for recalls and corrective measures
- · Data minimisation policy and five-year deletion schedule for the register, with deletion execution logs
Estimated first-time effort: 4–12 person-days (estimate, not a commitment)
Establish internal product safety processes and complete product identification and information
Severity MediumArt. 14；Art. 9(5)–(7)；Art. 13
Economic operators must have internal processes for product safety allowing them to comply on a continuing basis. Manufacturers must ensure the product bears a type, batch or serial number or another element enabling identification, easily visible and legible for consumers (or on the packaging or an accompanying document where size or nature does not allow it); must indicate their name, registered trade name or trade mark and postal and electronic address, including the single contact point address where different; and must accompany the product with clear instructions and safety information in a language easily understood by consumers as determined by the Member State, unless the product can be used safely and as intended without them.
- Applies when
- All manufacturers, and importers, distributors or own-branders on whom manufacturer obligations fall under Article 13.
- Evidence to retain
- · Internal product safety procedure and responsibility matrix
- · Artwork proof of product identification (type/batch/serial) and contact details
- · Final instructions and safety information in each language version
- · Mapping of language versions to target Member States
Estimated first-time effort: 5–15 person-days (estimate, not a commitment)