Module 19 2021

24/05/2021

Common pitfalls in technical files

• Lack of consistency e.g.: • Intended Purpose & clinical evidence • Key labelling claims and: • Benefit-risk and risk management • Performance evaluation / clinical evidence • Brochures, websites, videos etc. • Tech files not updated with PMS data

The Organisation for Professionals in Regulatory Affairs

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Other guidance on technical documentation

Recommendation NB-MED/2.5.1/Rec5 ‘Technical Documentation’ Publication date: 03.02.2000 http://www.team-nb.org/nb-med-documents/ This Recommendation was not written for IVD’s but could still be of use to IVD manufacturers.

The Organisation for Professionals in Regulatory Affairs

34

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