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Division 4 PROCESS REQUIREMENTSF1

United Kingdom Repealed

Original text. Later amendments are not shown.

  1. 4.1General
  2. 4.2Notified body quotations and pre-application activities
  3. 4.3Application review and contract
  4. 4.4Allocation of resources
  5. 4.5Conformity assessment activities
  6. 4.6Reporting
  7. 4.7Final review
  8. 4.8Decisions and Certifications
  9. 4.9Changes and modifications
  10. 4.10Surveillance activities and post-certification monitoring
  11. 4.11Re-certification

Annotations

Textual amendments

F1

Regulation revoked (31.12.2020) by The Medical Devices Regulations 2002 (S.I. 2002/618), reg. 4O (with savings and transitional provisions for N.I. in reg. 3ZA) (as amended by S.I. 2019/791, regs. 1(1), 3(7) and by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2; and as amended (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 4, 32); 2020 c. 1, Sch. 5 para. 1(1))