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Annex III TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCEF1

United Kingdom Repealed

Original text. Later amendments are not shown.

The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 78 to 81 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.

  1. 1The post-market surveillance plan drawn up in accordance with Article 79.
  2. 2The PSUR referred to in Article 81 and the post-market surveillance report referred to in Article 80.

Annotations

Textual amendments

F1

Regulation revoked (31.12.2020) by The Medical Devices Regulations 2002 (S.I. 2002/618), reg. 4P (as inserted by S.I. 2019/791, regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9(m)); 2020 c. 1, Sch. 5 para. 1(1))