The ISO13485 in its clauses 4.2.4 and 4.2.5 lists the requirements for document retention.
The retention is at 2 levels:
- Documents regarding manufacturing and testing which are obsolete
- Records
For obsolete documents the standard gives timelines as the highest of the following
- Device lifetime
- Retention period of corresponding record
Record retention follows the longest duration of the three:
- Two years from the date of release of the device
- Device lifetime
- Applicable regulatory requirements
Records fall into 3 distinct categories with different retention time considerations.
Category A: Design and Development Records
These records must be retained for at least the lifetime of the medical device after manufacture of the last product made to that design
Category B: Manufacturing and Distribution Records for Individual Devices or Batches
These records must be retained for at least the lifetime of that particular batch of medical devices
Category C: QMS Records
Examples of such records are MRM records, Internal Audit records, training records, calibration records, complaint records, supplier evaluation records. For such records, identify an appropriate retention period considering the nature of the medical device, associated risks, and applicable regulatory requirements. Keep the records for a minimum of two years.