Module 19: Regulation of In Vitro Diagnostic Medical Devices

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IVDR Annex II, main headings

6.3. Stability (excluding specimen stability)

• 6.3.1. Claimed shelf-life • 6.3.2. In-use stability • 6.3.3. Shipping stability •s/w development plan •s/w requirements analysis •s/w architectural design •s/w detailed design •s/w verification and validation … •s/w cyber security

6.4. Software verification and validation

The Organisation for Professionals in Regulatory Affairs

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IVDR Annex III technical documentation on post-market surveillance

1. The post-market surveillance plan drawn up in accordance with Article 79. – Requires a post-market performance follow-up

(PMPF) plan, or a justification as to why a PMPF is not applicable and a PMPF report.

The Organisation for Professionals in Regulatory Affairs

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