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Annex II TECHNICAL DOCUMENTATIONF1

United Kingdom Repealed

Original text. Later amendments are not shown.

The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex.

  1. 1DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
  2. 2INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
  3. 3DESIGN AND MANUFACTURING INFORMATION
  4. 4GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
  5. 5BENEFIT-RISK ANALYSIS AND RISK MANAGEMENT
  6. 6PRODUCT VERIFICATION AND VALIDATION

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))