Article 38 Procedure ... for dealing with PPE presenting a riskF15

Where the market surveillance F1authority has sufficient reason to believe that PPE covered by this Regulation presents a risk to the health or safety of persons, F2the authority shall carry out an evaluation in relation to the PPE concerned covering all relevant requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance F3authority for that purpose.

Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance F4authority finds that the PPE does not comply with the requirements laid down in this Regulation, F5the authority shall without delay require the relevant economic operator to take all appropriate corrective action to bring the PPE into compliance with those requirements, to withdraw the PPE from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as the authority may prescribe.

The market surveillance F6authority shall inform the relevant F7approved body accordingly.

Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.

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The economic operator shall ensure that all appropriate corrective action is taken in respect of all the PPE concerned that it has made available on the market F9....

Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance F10authority shall take all appropriate F11... measures to prohibit or restrict the PPE being made available on F12the market, to withdraw the PPE from that market or to recall it.

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