detected 2026-08-12 MODIFIED+13 −8§
no amending act named
applies from: unchanged
In Chapter II, Section 2.5, the phrase describing undesirable effects to be summarised as part of the benefit-risk analysis was changed to refer to undesirable side-effects instead.
Cited: Annex XV, v2
text before / after
32017R0745 → 02017R0745-20170505
ANNEX XV
CLINICAL INVESTIGATIONS
CHAPTER I
GENERAL REQUIREMENTS
1. Ethical principles
Each step in the clinical investigation, from the initial consideration of the need for and justification of the study to the publication of the results, shall be carried out in accordance with recognised ethical … 1,132 unchanged words … including length of time on the market and a review of performance, clinical benefit and safety-related issues and any corrective actions taken.
2.5. Summary of the benefit-risk analysis and the risk management, including information regarding known or foreseeable risks, any undesirable effects, side-effects, contraindications and warnings.
2.6. In the case of devices that incorporate a medicinal substance, including a human blood or plasma derivative or devices manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives, detailed information on the … 1,695 unchanged words … conclusions covering safety and performance results, assessment of risks and clinical benefits, discussion of clinical relevance in accordance with clinical state of the art, any specific precautions for specific patient populations, implications for the investigational device, limitations of the investigation.