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Division CHAPTER II REQUIREMENTS REGARDING DESIGN AND MANUFACTUREF1

United Kingdom Repealed

Original text. Later amendments are not shown.

  1. 10Chemical, physical and biological properties
  2. 11Infection and microbial contamination
  3. 12Division 12
  4. 13Devices incorporating materials of biological origin
  5. 14Construction of devices and interaction with their environment
  6. 15Devices with a diagnostic or measuring function
  7. 16Protection against radiation
  8. 17Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves
  9. 18Active devices and devices connected to them
  10. 19Particular requirements for active implantable devices
  11. 20Protection against mechanical and thermal risks
  12. 21Protection against the risks posed to the patient or user by devices supplying energy or substances
  13. 22Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons

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))