§7.4.2.1 Process

Market surveillance authorities must first contact the relevant economic operator, informing it about the findings and giving an opportunity to provide its view within period of no less than 10 working days (299). This step is skipped in case of urgency based on health, safety or other aspects of public interest grounds. In such case, the economic operator must be given such opportunity as soon as possible afterwards. The next step (300) is to require the relevant economic operator to take appropriate and proportionate corrective action to bring the non-compliance to an end or to eliminate the risk. The market surveillance authorities must also inform the relevant notified body (if any) in case an applicable safeguard procedure in the Union harmonisation legislation concerned specifies so (301). If there is a manufacturer, authorised representative or importer in the EU, the market surveillance authority should address them directly, unless the issue specifically relates to a distributor or another economic operator (302). If there is none of these economic operators in the EU, then, for certain categories of products, the market surveillance authority has the option of contacting the fulfilment service provider in the EU, if there is one. Otherwise, the market surveillance authority should attempt to contact the manufacturer in the third country. There is a range of actions possible, including but not limited to the actions listed in Article 16(3) of Regulation (EU) 2019/1020. These range from rectifying formal non-compliance to withdrawing or recalling the products. The action must be in accordance with the degree of risk or non-compliance, and the impact on the free circulation of products may not go beyond what is necessary for achieving the objectives of market surveillance (see Section 7.4.2.2). A different approach may apply in the case of serious risk. Market surveillance authorities carry out a risk assessment in order to verify if products present a serious risk. According to Article 19(2) of Regulation (EU) 2019/1020, an appropriate risk assessment ‘takes account of the nature of the hazard and the likelihood of its occurrence’. In case the risk is deemed to be ‘serious’, market surveillance authorities must adopt a rapid intervention following the specific provisions of Articles 19 and 20 of Regulation (EU) 2019/1020. The types of actions in this case consist in withdrawing or recalling the products, except where there is another effective way to eliminate the serious risk. Market surveillance authorities may, in these urgent cases, adopt restrictive measures without waiting for the economic operator to take corrective action. In such case, the economic operator must be given an opportunity to provide its view as soon as possible after a decision, order or measure taken, which shall then be reviewed promptly by the market surveillance authority (Article 18(3) of Regulation (EU) 2019/1020). Economic operators must ensure that the corrective action is taken throughout the EU. If the non-compliance or risk relates only to part of a series of products manufactured that can be reliably identified, only that part needs to be addressed. If there is a doubt about either the risk being limited to a certain part or the reliable identification of that part, the corrective action should concern all the products/series. For an isolated error, limited to the territory of the Member State that has discovered the non-compliance, there is no need to take action throughout the EU. Market surveillance authorities have to verify that corrective action has been taken. If an economic operator does not take adequate corrective action within the period indicated by a market surveillance authority, the market surveillance authorities have to take appropriate measures to prohibit or restrict the making available of the product on their national market, to withdraw the product from that market or to recall it. These measures have to be communicated to the relevant economic operator without delay. Market surveillance authorities must inform the Commission and the other Member States about the results of the compliance evaluation and about the actions required of the economic operator or the measures adopted. In case of serious risk, market surveillance authorities notify to the Commission through RAPEX system of any voluntary or compulsory measure according to the procedure laid down in Article 20 of Regulation (EU) 2019/1020 and/or Article 12 of Directive 2001/95 on general product safety. In the case of products that do not present a serious risk, the Commission and the other Member States will be informed by means of the information support system provided for in Article 34 of Regulation (EU) 2019/1020 and, where appropriate, Article 11 of Directive 2001/95 on general product safety. Market surveillance authorities in the other Member States will normally have to follow up on the notification by verifying whether the same product has been made available on their territories and by adopting appropriate measures. Additional information on this is provided in Sections 7.5.1 and 7.5.2, as well as in the RAPEX guidelines. Any measure, decision or order taken or made by national market surveillance authorities must state the exact grounds on which it is based. The relevant economic operator must be notified. They must also be informed about the remedies available under the national law in force in the Member State in question, and of the time limits for such remedies.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07