Part I Introductory Provisions Relating to all Medical Devices

United Kingdom

1. 1Citation and commencement
2. 1ZAExpiry of certain provisions in these Regulations
3. 1ASchedules
4. 2Interpretation
5. 2AMedical devices which are qualifying Northern Ireland goods
6. 3Scope of these Regulations
7. 3ZARevocation, transitional and saving provisions in respect of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
8. 3ADesignated standard
9. 3BConfidentiality
10. 4Transitional provisions
11. 4ATransitional provisions for hip, knee and shoulder replacements
12. 4DRevocations, transitional and saving provisions in respect of the new national registration requirements
13. 4HRevocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date
14. 4IRevocation of Commission Decision 2010/227
15. 4JRevocation of Commission Regulation (EU) No 207/2012 on 26th May 2025
16. 4KRevocation of Regulation (EU) No 722/2012 on 26th May 2025
17. 4LRevocation of Regulation (EU) No 920/2013 on 26th May 2025 and its effect before that date
18. 4MRevocation of Regulation (EU) No 2017/2185 and saving provision
19. 4NThe classification criteria in Directives 2003/12 and 2005/50
20. 4ORevocation of Regulation (EU) 2017/745
21. 4PRevocation of Regulation (EU) 2017/746
22. 4TReferences in other legislation to Directives 90/385, 93/42 and 98/79