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Annex XIII PROCEDURE FOR CUSTOM-MADE DEVICESF1

United Kingdom Repealed

Original text. Later amendments are not shown.

  1. 1For custom-made devices, the manufacturer or its authorised representative shall draw up a statement containing all of the following information:
  2. 2Division 2
  3. 3Division 3
  4. 4The statement referred to in the introductory part of Section 1 shall be kept for a period of at least 10 years after the device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years.
  5. 5Division 5

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))