Annex II TECHNICAL DOCUMENTATIONF1
United Kingdom Repealed
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.
- 1DEVICE DESCRIPTION AND SPECIFICATION, INCLUDING VARIANTS AND ACCESSORIES
- 2INFORMATION TO BE SUPPLIED BY THE MANUFACTURER
- 3DESIGN AND MANUFACTURING INFORMATION
- 4GENERAL SAFETY AND PERFORMANCE REQUIREMENTS
- 5BENFIT-RISK ANALYSIS AND RISK MANAGEMENT
- 6PRODUCT VERIFICATION AND VALIDATION
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))