Part II General Medical Devices

United Kingdom

1. 5Interpretation of Part II
2. 6Scope of Part II
3. 7Classification of general medical devices
4. 7ARegistration of persons placing general medical devices on the market
5. 8Essential requirements for general medical devices
6. 9Determining compliance of general medical devices with relevant essential requirements
7. 10UK marking of general medical devices
8. 10AUK(NI) indication: general medical devices
9. 11UK marking of general medical devices that come within the scope of this Part and other legislation
10. 12Exemptions from regulations 8 and 10
11. 13Procedures for affixing a UK marking to general medical devices
12. 14Procedures for systems and procedure packs, and for devices to be sterilised before use
13. 15Procedures for custom-made general medical devices
14. 16Procedures for general medical devices for clinical investigations
15. 17Manufacturers etc. and conformity assessment procedures for general medical devices
16. 18Approved bodies and the conformity assessment procedures for general medical devices
17. 19Registration of persons placing general medical devices on the market
18. 19AAdditional requirements relating to use of animal tissues
19. 19BObligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42
20. 19CObligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/745