Module 15 Presentations

4/15/2024

2017/745 Annex II – Technical Documentation

• (c) the clinical evaluation report and its updates and the clinical evaluation plan referred to in Article 61(12) and Part A of Annex XIV;

• (d) the PMCF plan and PMCF evaluation report referred to in Part B of Annex XIV or a justification why a PMCF is not applicable.

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Best Practice Considerations for Technical Documentation

Justification

Ensure that justifications are scientific

Completeness

Ensure that your submission is complete

Imperfections

Address the imperfections

Navigation

Provide a technical documentation road map to aid the audit process

The Big Stuff!

Focus on the significant issues

Communication

Communicate concisely

Claims

Don’t make unsubstantiated claims

Traceability

Ensure all requirements are traceable to evidence of verification and validation Ensure that there is consistency across supporting documents

Internal Audit

Audit your technical documentation before submission to the NB Be responsive to your NB

Consistency

Responsive

No Repetition

Avoid repetition

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