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Division CHAPTER II REQUIREMENTS REGARDING PERFORMANCE, DESIGN AND MANUFACTUREF1

United Kingdom Repealed

Original text. Later amendments are not shown.

  1. 9Performance characteristics
  2. 10Chemical, physical and biological properties
  3. 11Infection and microbial contamination
  4. 12Devices incorporating materials of biological origin
  5. 13Construction of devices and interaction with their environment
  6. 14Devices with a measuring function
  7. 15Protection against radiation
  8. 16Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves
  9. 17Devices connected to or equipped with an energy source
  10. 18Protection against mechanical and thermal risks
  11. 19Protection against the risks posed by devices intended for self-testing or near-patient testing

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))