Module 5 Presentations

16/07/2024

Where do the GSPR’s come in?

GSPRs

Research + Theory

Lab Testing

Clinical Investigation Clinical Endpoints Clinical Evaluation

Pre-Clinical

Informal Testing

GSPRs

This Photo by Unknown Author is licensed under CC BY-NC

All the above is to PROVE clinical performance in the real world will be safe and effective → benefits > risk → GSPRs are met

The Organisation for Professionals in Regulatory Affairs

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Art. 62 General Requirements

• Minimize Distress • Appropriate Medical Care

# 2 & 3 Ethical Design

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# 4 General • MS Approval • No –ve Ethics opinion

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• No undue influence • Device meets GSPRs • lab testing where possible • pre-clinical evaluation • health & safety • SotA Annex XV • 5 IC: 3 rd Party Withdraw • 6 & 7 Prof. Facilities/Investigator

• Sponsor “EU Rep” • protect vulnerable • Σbenefits>Σrisks+ • informed consent • physical, mental, privacy inc. data

The Organisation for Professionals in Regulatory Affairs

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