ANNEXES

ANNEX XIIIPERFORMANCE EVALUATION, PERFORMANCE STUDIES AND POST-MARKET PERFORMANCE FOLLOW-UP

PART APERFORMANCE EVALUATION AND PERFORMANCE STUDIES

3.OTHER PERFORMANCE STUDIES

By analogy, the performance study plan referred to in Section 2.3.2, and the performance study report, referred to in Section 2.3.3, shall be documented for other performance studies than clinical performance studies.