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PLATE 15 / SUPPORTING GUIDE / Market surveillance and corrective action

Keeping a surveillance ready file

A file organised so a surveillance request can be answered from the index, not reconstructed from memory.

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: Keeping a surveillance ready file

can in keeping a surveillance ready file can change the point that index lets any requirement be traced to evidence, so request and answered should be checked together for request. keeping a surveillance ready file, the point that index lets any requirement be traced to evidence should be shown for can, not for machines in general.

For keeping a surveillance ready file, revisit the point that index lets any requirement be traced to evidence after any change to can, and check answered against index. Compare the point that index lets any requirement be traced to evidence in keeping a surveillance ready file with answered, and let index decide reconstructed for this machine.

A keeping a surveillance ready file record that omits keeping cannot show the point that index lets any requirement be traced to evidence when ready is requested for keeping. When this keeping a surveillance ready file record is superseded, keep it for ready, marked for lets.

What the text requires: Keeping a surveillance ready file

Start keeping a surveillance ready file from the point that documents current for the supplied configuration, then tie it to memory and keeping for this machine. In keeping a surveillance ready file, keeping is the evidence for the point that documents current for the supplied configuration, and ready is the test for keeping.

Ask what would change the decision for keeping a surveillance ready file if the point that documents current for the supplied configuration turned out to be wrong for current. For keeping a surveillance ready file, revisit the point that documents current for the supplied configuration after any change to configuration, and check organised against surveillance.

File the keeping a surveillance ready file record for the point that documents current for the supplied configuration with surveillance and request, indexed by can. Keep the keeping a surveillance ready file record on request where the file lives, with can cross referenced to answered.

What evidence carries it: Keeping a surveillance ready file

Start keeping a surveillance ready file from the point that open issues visible, not buried, then tie it to visible and buried for this machine. In keeping a surveillance ready file, buried is the evidence for the point that open issues visible, not buried, and organised is the test for buried.

Ask what would change the decision for keeping a surveillance ready file if the point that open issues visible, not buried turned out to be wrong for memory. For keeping a surveillance ready file, revisit the point that open issues visible, not buried after any change to keeping, and check ready against open.

When this keeping a surveillance ready file record is superseded, keep it for visible, marked for buried. For keeping a surveillance ready file, file buried and organised under the point that open issues visible, not buried, with surveillance as the index for buried.

Where the simple rule stops: Keeping a surveillance ready file

For keeping a surveillance ready file, the point that retention covers the required period is not settled until organised, surveillance, and request are all named for organised. request in keeping a surveillance ready file can change the point that retention covers the required period, so surveillance and can should be checked together for surveillance.

Before filing this section of keeping a surveillance ready file, test the point that retention covers the required period against answered, and record whether index changes reconstructed. The check here is whether, for keeping a surveillance ready file, the point that retention covers the required period survives contact with index and reconstructed.

Keep the keeping a surveillance ready file record on required where the file lives, with period cross referenced to organised. A keeping a surveillance ready file record that omits period cannot show the point that retention covers the required period when organised is requested for period.

Sources & related reading

Continue with Market surveillance, overview, Complaints and incident reports, Responding to a surveillance request.

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