Module 19 2021

24/05/2021

IVDR Annex II, main headings

● 6.2. Information on clinical performance and clinical evidence. Performance Evaluation Report Comment: – The performance evaluation report includes reports on scientific validity, analytical and clinical performance, together with an assessment of those reports, therefore many new reports required. ● 6.3. Stability (excluding specimen stability)

– 6.3.1. Claimed shelf-life – 6.3.2. In-use stability – 6.3.3. Shipping stability ● 6.4. Software verification and validation

The Organisation for Professionals in Regulatory Affairs

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IVDR Annex II, main headings

6.5 Additional information required in specific cases (a) (devices placed on the market in a sterile or defined microbiological condition) (b) (devices containing tissues, cells and substances of animal, human or microbial origin) (c) (devices placed on the market with a measuring function) (d) (if the device is to be connected to other equipment in order to operate as intended)

The Organisation for Professionals in Regulatory Affairs

30

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