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Part 3A Performance studies under Regulation (EU) 2017/746F1

  1. 17BLegal representatives and contact persons for performance studies
  2. 17CEthical review of performance studies
  3. 17DArbitration following the refusal of a performance study application
  4. 17EDamage compensation in relation to performance studies
  5. 17FRetention of documentation relating to performance studies

Annotations

Textual amendments

F1

Pt. 3A inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 36