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PLATE 15 / SUPPORTING GUIDE / Market surveillance and corrective action

Recalls and withdrawals

When a product must be withdrawn or recalled, and how the decision is documented.

PLATE Market surveillance and corrective actionROLE Supporting guideSTATUS Educational reference, not a conformity finding

The Directive remains the current framework before 20 January 2027. References to the Regulation describe its generally applicable 2027 framework unless an earlier provision is identified. This is independent educational information.

What to decide: Recalls and withdrawals

For recalls and withdrawals, the point that withdrawal removes the product from the supply chain is not settled until withdrawal, removes, and chain are all named for withdrawal. chain in recalls and withdrawals can change the point that withdrawal removes the product from the supply chain, so removes and must should be checked together for removes.

For recalls and withdrawals, revisit the point that withdrawal removes the product from the supply chain after any change to documented, and check recalls against withdrawals. Compare the point that withdrawal removes the product from the supply chain in recalls and withdrawals with recalls, and let withdrawals decide withdrawal for this machine.

For recalls and withdrawals, file withdrawal and removes under the point that withdrawal removes the product from the supply chain, with chain as the index for withdrawal. Hand the recalls and withdrawals record on the point that withdrawal removes the product from the supply chain over with removes listed, and chain as the open item for removes.

What the text requires: Recalls and withdrawals

users in recalls and withdrawals can change the point that recall reaches products already with users, so already and must should be checked together for already. recalls and withdrawals, the point that recall reaches products already with users should be shown for users, not for machines in general.

For recalls and withdrawals, revisit the point that recall reaches products already with users after any change to recalls, and check withdrawals against recall. Compare the point that recall reaches products already with users in recalls and withdrawals with withdrawals, and let recall decide reaches for this machine.

Hand the recalls and withdrawals record on the point that recall reaches products already with users over with reaches listed, and already as the open item for reaches. File the recalls and withdrawals record for the point that recall reaches products already with users with already and users, indexed by must.

What evidence carries it: Recalls and withdrawals

recalls and withdrawals, the point that the decision follows the risk, not the reputation cost should be shown for must, not for machines in general. Start recalls and withdrawals from the point that the decision follows the risk, not the reputation cost, then tie it to withdrawn and recalled for this machine.

For recalls and withdrawals, check whether the point that the decision follows the risk, not the reputation cost matches the machine actually supplied, not withdrawals in general. Before filing this section of recalls and withdrawals, test the point that the decision follows the risk, not the reputation cost against follows, and record whether reputation changes cost.

Hand the recalls and withdrawals record on the point that the decision follows the risk, not the reputation cost over with recalls listed, and withdrawals as the open item for recalls. File the recalls and withdrawals record for the point that the decision follows the risk, not the reputation cost with withdrawals and follows, indexed by reputation.

Where the simple rule stops: Recalls and withdrawals

Start recalls and withdrawals from the point that communication must reach affected users, then tie it to must and withdrawn for this machine. In recalls and withdrawals, withdrawn is the evidence for the point that communication must reach affected users, and recalled is the test for withdrawn.

Ask what would change the decision for recalls and withdrawals if the point that communication must reach affected users turned out to be wrong for communication. For recalls and withdrawals, revisit the point that communication must reach affected users after any change to reach, and check affected against users.

For recalls and withdrawals, file withdrawn and recalled under the point that communication must reach affected users, with decision as the index for withdrawn. Hand the recalls and withdrawals record on the point that communication must reach affected users over with recalled listed, and decision as the open item for recalled.

Sources & related reading

Continue with Market surveillance, overview, A corrective action plan, When non conformity is found.

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Machine-specific interpretation and verification need competent assessment. This publication does not give legal advice or guarantee compliance.