1. Purpose and scope
Medical devices are often supported far longer than the consumer and industrial products that share their components. A chip or component can be discontinued while devices are still being built or serviced, and every response has a regulatory cost: a last-time buy ties up money and needs storage that preserves the parts; a replacement part is a change that must be verified and assessed for significance; a redesign reopens design controls. This stage plans those responses so they are taken calmly rather than under the pressure of a final order date.
The stage also covers the deliberate end of a device's life. The manufacturer decides when service, spare parts and security updates end, tells customers and authorities in good time, supports the last devices to that date, updates or withdraws registrations and certificates, and archives the design history file, device master record, device history records and the tool environments needed to read them for the retention period the regulations require.
For a chip supplier, the stage is its own discontinuance: notifying device makers under the terms of quality agreements, offering last-time buys or die banks, and keeping records and failure analysis capability for parts still in the field.
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