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PART I Introductory Provisions Relating to all Medical Devices
2A.Medical devices which are qualifying Northern Ireland goods
3ZA.Revocation, transitional and saving provisions in respect of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
4A.Transitional provisions for hip, knee and shoulder replacements
4D.Revocations, transitional and saving provisions in respect of the new national registration requirements
4H.Revocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date
4J.Revocation of Commission Regulation (EU) No 207/2012 on 26th May 2025
4K.Revocation of Regulation (EU) No 722/2012 on 26th May 2025
4L.Revocation of Regulation (EU) No 920/2013 on 26th May 2025 and its effect before that date
4M.Revocation of Regulation (EU) No 2017/2185 and saving provision
4N.The classification criteria in Directives 2003/12 and 2005/50
4T.References in other legislation to Directives 90/385, 93/42 and 98/79
PART II General Medical Devices
7A.Registration of persons placing general medical devices on the market
9.Determining compliance of general medical devices with relevant essential requirements
11.UK marking of general medical devices that come within the scope of this Part and other legislation
13.Procedures for affixing a UK marking to general medical devices
14.Procedures for systems and procedure packs, and for devices to be sterilised before use
16.Procedures for general medical devices for clinical investigations
17.Manufacturers etc. and conformity assessment procedures for general medical devices
18.Approved bodies and the conformity assessment procedures for general medical devices
19.Registration of persons placing general medical devices on the market
19A.Additional requirements relating to use of animal tissues
19B.Obligations in Part II of these Regulations which are met by complying with obligations in Directive 93/42
19C.Obligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/745
PART III Active Implantable Medical Devices
21A.Registration of persons placing active implantable medical devices on the market
21B.Registration of persons placing active implantable medical devices on the market
21C.Requirement to appoint a UK responsible person for active implantable medical devices
22. Essential requirements for active implantable medical devices
23. Determining compliance of active implantable medical devices with relevant essential requirements
25. UK marking of active implantable medical devices that come within the scope of this Part and other legislation
27. Procedures for affixing a UK marking to active implantable medical devices
28. Procedures for custom-made active implantable medical devices
29.Procedures for active implantable medical devices for clinical investigations
30. Manufacturers etc. and conformity assessment procedures for active implantable medical devices
30A.Obligations in Part III which are met by complying with obligations in Directive 90/385
31. Approved bodies and the conformity assessment procedures for active implantable medical devices
PART IV In Vitro Diagnostic Medical Devices
33A.Registration etc. of persons placing in vitro diagnostic medical devices on the market
34.Essential requirements for in vitro diagnostic medical devices
34D.Exemption for coronavirus test devices in conformity with Regulation (EU) 2017/746 and Regulation (EU) 2022/1107
35.Determining compliance of in vitro diagnostic medical devices with relevant essential requirements
37.UK marking of in vitro diagnostic devices that come within the scope of this Part and other legislation
40.Procedures for affixing a UK marking to in vitro diagnostic medical devices
41.Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices
42.Approved bodies and the conformity assessment procedures for in vitro diagnostic medical devices
44.Registration of persons placing in vitro diagnostic medical devices on the market or for performance evaluation
44ZA.Obligations in Part IV which are met by complying with obligations in Directive 98/79
44ZB.Obligations in Part IV of these Regulations which are met by complying with obligations in Regulation (EU) 2017/746
PART V Approved Bodies, Conformity Assessment Bodies and Marking of Products
PART VI Fees charged by the Secretary of State
53.Fees in connection with the registration of devices and changes to registration details
54.Fees payable in connection with the designation of approved bodies
55.Fees payable in connection with the designation etc. of ... conformity assessment bodies
56.Fees payable in relation to clinical investigation notices
56A.Fees in connection with approval of coronavirus test devices
56B.Circumstances in which a fee is payable in relation to a consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device
56C.Fees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device
56D.Fees payable in connection with pre-consultation meetings
1.The agreement on mutual recognition in relation to conformity assessment...
2.The agreement on mutual recognition in relation to conformity assessment...
3.The agreement on mutual recognition between the European Community and...
4.The agreement on mutual recognition between the European Community and...
5.The agreement between the European Community and the Swiss Confederation...
Modification of Annexes to Directives 90/385, 93/42, 98/79
PART 1 Modification of Annexes to Directive 90/385
1.(1) The Annexes to Directive 90/385 are modified so that...
3.In Annex 2— (a) for the heading substitute “Declaration of...
5.For Annex 4 substitute— ANNEX 4 VERIFICATION Verification is the procedure whereby the manufacturer ensures and declares...
6.For Annex 5, substitute— ANNEX 5 DECLARATION OF CONFORMITY TO...
7.In Annex 6— (a) in Section 1, for “authorised representative...
8.In Annex 7— (a) in Section 1.1 for “harmonised” substitute...