The Medical Devices Regulations 2002

[^V_NI_6fe88f79-5a5c-a198-c290-ad5e0190c79d]: Words in reg. 45(2)(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(2)

[^V_NI_73b8be12-8af2-3ca2-1109-4b50c3984814]: Reg. 47(9)(10) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 15

[^V_NI_7503561e-c370-ab99-8bee-d36746f0097c]: Words in reg. 16(1)(a) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 9(a)

[^V_NI_760918c3-c3c8-347d-d879-46c8f05f8d81]: Council Directive 76/768/EEC was amended for the twenty-sixth time by Commission Directive 2000/41/EC (OJ No. L 145, 20.6.2000, p.25).

[^V_NI_7861fc64-e8d1-8ce6-6b2a-9157f3c2edd5]: Words in reg. 45(8) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(4)

[^V_NI_7b8e2839-6eb0-f656-c018-34649b769835]: Reg. 18(4) added (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 8

[^V_NI_7c747a77-9dd6-e284-0801-79f1e67b26df]: Words in reg. 60(4) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 17(b)

[^V_NI_7d7baa6a-9755-4c09-7daa-575163c419c5]: OJ No. L 204, 21.7.1998, p.37; amended by Directive 98/48/EC (OJ No. L 217, 5.8.1998, p.18).

[^V_NI_826021bb-751b-e288-2e25-7bdb8fec672d]: Words in reg. 2(1) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(g)

[^V_NI_8455cae3-4eab-9783-3957-f49bea5c9cbf]: Sum in reg. 54(3A)(a)(i) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(5)(a)

[^V_NI_863fda3c-e371-bb07-e455-0c4bdc01990b]: Words in reg. 55(3) inserted (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(3)(c)(i)

[^V_NI_89b9ca79-d322-0aa7-39d9-a1690a69a434]: Reg. 8(3) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 5

[^V_NI_8abc564b-7263-204a-d695-92479ea6b66a]: Words in reg. 2(1) substituted (1.7.2012) by The Medical Devices (Amendment) Regulations 2012 (S.I. 2012/1426), regs. 1(1), 2(a)(ii)

[^V_NI_8b83b01c-8880-6eee-e1cd-af0110135e58]: Reg. 13(5)(6) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(3)

[^V_NI_8c009c38-827f-7b64-5a22-e2557e2c276e]: Sum in reg. 54(1)(b) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(2)(b)

[^V_NI_9010ccd2-877d-c330-85e0-315e986fc0b8]: Reg. 17(4)(5) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 7

[^V_NI_925fa44a-2622-f1e8-3123-d70262d769a7]: Words in reg. 45(5)(b) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(4)

[^V_NI_9513d541-bf8a-7b43-5499-ee7fe037a696]: Sums in reg. 56(1)(a) substituted (1.4.2013) by The Medical Devices (Fees Amendment) Regulations 2013 (S.I. 2013/525), regs. 1, 2(2)(a)

[^V_NI_95a5d6a1-529f-a1ee-8430-83dff7670ac9]: Words in reg. 3(d) inserted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(b)

[^V_NI_96f6c5f0-83b9-f3ce-6896-cd76c4459a70]: Reg. 9(5A) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 6(a)

[^V_NI_97fc10bc-59aa-5967-6073-0eed97435de4]: Words in reg. 54(4)(a) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(i)

[^V_NI_9da094b0-ee8a-0574-8799-7a16d11f0c74]: Words in reg. 2(1) inserted (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 2(c)

[^V_NI_9ed51aa0-a1e4-cd8c-c39b-984d81e10c01]: Reg. 55(3)(a)-(d) substituted for reg. 55(3)(a)-(c) (1.4.2007) by The Medicines for Human Use and Medical Devices (Fees Amendments) (No.2) Regulations 2007 (S.I. 2007/803), regs. 1(1)(b), 13(3)(c)(ii)

[^V_NI_9eee6006-c0ee-c210-bf56-7d3b0e76c1e0]: Sum in reg. 54(3A)(a)(ii) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(5)(b)

[^V_NI_a1af5c54-7949-af67-d88c-001569b6250f]: Words in reg. 2(1) substituted (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 2(f)

[^V_NI_a3925b1c-6bcd-7b66-1390-01c1e14af32b]: Words in reg. 56(2) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 5(2)

[^V_NI_a7ed39e2-9fbe-9dc9-7e19-2e51de884b41]: Words in reg. 3(d) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(b)

[^V_NI_aa9f99dc-bec0-cbd3-a9ec-5e407f377593]: Sum in reg. 54(3)(a) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(4)(a)

[^V_NI_ab88a817-b194-4dca-a30d-314183cdd492]: Words in reg. 2(1) substituted (1.7.2012) by The Medical Devices (Amendment) Regulations 2012 (S.I. 2012/1426), regs. 1(1), 2(a)(iii)

[^V_NI_af08eddc-dc66-3dd4-fda7-331be035d4ba]: Reg. 56(3A) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 5(3)

[^V_NI_af3d41cb-68d0-a622-fb97-9a2365e1414c]: OJ No. L 262, 27.9.1976, p.169.

[^V_NI_b06a8a74-0205-c76d-1201-e7a676a4ad2c]: Words in reg. 2(1) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(c)

[^V_NI_bde1a685-c141-d3c8-1f27-5995c5954b93]: Sum in reg. 54(3)(b) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(4)(b)

[^V_NI_c0d668b4-57a8-9f92-ff45-818be5cec0a8]: Words in reg. 2(1) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 2(a)

[^V_NI_c2056b3a-e22b-c652-bccc-78a3ad59a349]: Reg. 14(4)(a) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 7(a)

[^V_NI_c2dc0a64-b433-1bc5-df97-122faeb067fc]: Words in reg. 3(d) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(a)

[^V_NI_c7139760-9bf1-4971-60eb-e61a80d17e07]: Reg. 2(1B) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(6)

[^V_NI_c80480e1-c507-2d7c-4406-024b32ebe0f4]: Words in reg. 3(c) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(a)

[^V_NI_c86a2768-de48-8c20-a26a-76492582e747]: Words in reg. 18(2) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 10

[^V_NI_c906b54d-863d-4b3e-73cf-4976d3e05bd6]: Words in reg. 54(4)(b) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(b)

[^V_NI_cb10a0d3-7d50-f38f-bbee-2c15eddbe950]: Words in reg. 7 inserted (1.9.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(b), 5

[^V_NI_d414df18-e38e-f58e-6911-db801b79c137]: Words in reg. 31(2) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 15

[^V_NI_d4879a90-60d5-7b4b-51b8-70ff980da578]: Words in reg. 54(4)(a) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(ii)

[^V_NI_d512e248-8026-a09f-b4a8-bf5908c20e0e]: Reg. 30(3)-(5) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 14

[^V_NI_d5aef15c-0701-2994-184c-05cc10f1b296]: Reg. 61(7A) inserted (22.11.2005) by The Medical Devices (Amendment) Regulations 2005 (S.I. 2005/2909), regs. 1, 2(b)

[^V_NI_dab53698-d283-b0c5-0900-5bfb56d80501]: Words in reg. 2(1) inserted (30.10.2005) by The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 (S.I. 2005/2759), reg. 1(a), Sch. para. 10

[^V_NI_db2f435d-c717-b2ec-7389-846a0d999504]: Words in reg. 16(1)(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 6

[^V_NI_df39f40b-46dd-766a-f6a3-264269f82811]: Words in reg. 2(1) inserted (1.9.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(b), 2(a)

[^V_NI_e2ef6420-0f99-87cb-3bc4-817917cbe7b6]: Word in reg. 13(4)(c) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(b)

[^V_NI_e311f367-7a66-3a7f-4755-fe1ad57393a5]: Word in reg. 27(c) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 11(b)

[^V_NI_e49ce772-7a19-4e3c-42e9-29c55d48df01]: Word in reg. 27(b) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 11(a)

[^V_NI_e560e1ff-a823-6d2a-ba5c-a898435e05ca]: Words in reg. 15(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 5

[^V_NI_e6e104cc-9e51-ea55-b5f0-c132fc314a01]: See section 45(1) of that Act.

[^V_NI_e77467d7-ab3a-0565-2828-dbd02451b37d]: Reg. 2(1A) inserted (1.7.2012) by The Medical Devices (Amendment) Regulations 2012 (S.I. 2012/1426), regs. 1(1), 2(b)

[^V_NI_e99596b5-7ad3-c74d-31a2-21c9bf48e90a]: Words in reg. 45(2)(b) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(3)

[^V_NI_ee56de70-402e-2e5a-6ebc-69fe8001b9a0]: Words in reg. 2(1) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(f)

[^V_NI_eee39433-2788-2149-e537-0f1b2996f4da]: Words in reg. 54(4)(a)(ii) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(7)(a)(iii)

[^V_NI_f0cf8586-ce38-9e06-a882-c38cc9426465]: Sums in reg. 55(3B) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(e)

[^V_NI_f0e02577-b642-76a2-4d54-192330efb520]: Words in reg. 28(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 12

[^V_NI_f2892f9e-a7d8-0bf9-a086-e920468a32ab]: Words in reg. 2(1) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(2)(c)

[^V_NI_f8e9f85c-abaf-efb7-bea0-7854c5a92c63]: Reg. 67 inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 18

[^V_NI_fabb7f29-3f8b-7900-a71d-6a2ec28464de]: Words in Regulations substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2, 4 (with art. 3(3))

[^V_NI_fc3f4d35-e139-6961-3795-f11010831f7b]: Words in reg. 3(e)(ii) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(c)

[^V_NI_ffa4ccd5-bd3a-4437-f83b-0151817b9cbf]: Reg. 29(10) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 13

[^key-65b6270f02898f0d07f65f0a8f35dd10]: Reg. 34D inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 17

[^key-d7722f930e51e3769272d86a8c8aa9df]: Words in reg. 2(1) inserted (E.W.S.) (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 9

[^key-f68b2229df1d2b1afc8305e176463bdb]: Words in reg. 2(1) inserted (N.I.) (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 10

[^key-8982d39f915224a2ef67960892225e20]: Words in reg. 2A(1) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 11(a)(i)

[^key-a607472b0851c4afff1886a93d22476e]: Reg. 2A(1)(a) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 11(a)(ii)

[^key-6c9a14d506f35638fdb564ff62ce5dd6]: Reg. 2A(1A) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 11(b)

[^key-32cc8a88df9b935d7b164d0191fa9ebd]: Words in reg. 3ZA heading inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(a)

[^key-3eaefbfdd6be2cae2d4327241b698202]: Reg. 3ZA(1) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(b)

[^key-5b98268b9aaa7b6235001e5dfa90c445]: Words in reg. 3ZA(2) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(c)(i)

[^key-aef728e9fa7b47ec0b1debc862d93da1]: Reg. 3ZA(2)(a)(aa) substituted for reg. 3ZA(2)(a) (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(c)(ii)

[^key-dacda692ad77a2c79bddde75fb7e81a1]: Word in reg. 3ZA(2)(b) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(c)(iii)

[^key-f3940b30ef370bc37de74139a7b33a5b]: Words in reg. 3ZA(3) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(d)(i)

[^key-2bdea24f2d945631dcc1cd7d8154b597]: Words in reg. 3ZA(3) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(d)(ii)

[^key-540325468cc30c5b5cde13a62b572543]: Words in reg. 3ZA(3)(a) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(d)(iii)

[^key-e7bd0de4c26561e1826c13650f4a819f]: Words in reg. 3ZA(3)(b) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 12(d)(iv)

[^key-c1ae3837038ce52f5c588b2fa30b1651]: Reg. 4T(1) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 13

[^key-13922542a4d4ef05e912568d1a3b8502]: Reg. 19B omitted (N.I.) (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 14

[^key-984cada5ec4efa45c0aef7a02e12e803]: Reg. 21C omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 15

[^key-71aeb7d70ca65d97ca141d1d247dab0d]: Words in reg. 34A(1) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 16

[^key-bfc19c41dc3443ff0060428ea42a7406]: Words in reg. 34A(2) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 16

[^key-e5905accfe9f1f4108236d3b404b1d05]: Reg. 44(1)(a)(ii) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 18(a)

[^key-4d1bdc190158971440fc07e91cd6a7c1]: Reg. 44(2)(c) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 18(b)

[^key-d3735c7544464f4f4b7ca5706cef9c64]: Reg. 44(5) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 18(c)

[^key-37f4b8d06b8cee8cd0a2b357cc33240e]: Reg. 44(6) omitted (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 18(d)

[^key-df0f5ae9a23c2c0a740dc0899713b39a]: Reg. 44ZA omitted (N.I.) (21.3.2024) by virtue of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 19

[^key-04cb463e859053a6cb0f87be86cfab76]: Reg. 4H omitted (24.5.2025) by virtue of The Medical Devices (Amendment) (Great Britain) Regulations 2025 (S.I. 2025/591), regs. 1(2), 2(2)(a)

[^key-7a21756850e73f8dcd23b93a7752e9f4]: Reg. 4J omitted (24.5.2025) by virtue of The Medical Devices (Amendment) (Great Britain) Regulations 2025 (S.I. 2025/591), regs. 1(2), 2(2)(b)

[^key-b931ca3748a30d5620ef4fe7bbe63b88]: Reg. 4K omitted (24.5.2025) by virtue of The Medical Devices (Amendment) (Great Britain) Regulations 2025 (S.I. 2025/591), regs. 1(2), 2(2)(c)

[^key-2ae69d28eff56ea0e9552c3ea2b11e21]: Reg. 4L omitted (24.5.2025) by virtue of The Medical Devices (Amendment) (Great Britain) Regulations 2025 (S.I. 2025/591), regs. 1(2), 2(2)(d)

[^M_F_3ea2bf58-0467-4d53-e732-88c35c5142c3]: Reg. 4D inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_8fbc6de2-b8c4-42a3-be4f-42ccd581e630]: Reg. 4T inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 9); 2020 c. 1, Sch. 5 para. 1(1)

[^key-7aac0da14fb1953d3c468abc4b16422d]: Pt. 4A inserted (E.W.S.) (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 4

[^key-2cd276f57139c109b031727e194475cc]: Words in reg. 2(1) substituted (E.W.S.) (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 3(a)

[^key-9c00c3ffd6656c298719b61a0bfd85d7]: Words in reg. 2(1) substituted (E.W.S.) (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 3(b)

[^key-fa669063c22a41abb2fe540472fad587]: Words in reg. 2(1) inserted (E.W.S.) (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 3(c)

[^key-864142dedf53b3afb2c1207d59461b8b]: Sch. 2A para. 3(f)(ii) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(2) (with reg. 6)

[^key-0a4eb31e032737a5a3770cee12c2930d]: Words in Sch. 2A para. 5 omitted (17.6.2025) by virtue of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(3) (with reg. 6)

[^key-0a54627bdf6d4341f6d518b62402dbd4]: Words in Sch. 2A para. 6 omitted (17.6.2025) by virtue of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(4) (with reg. 6)

[^key-0ab1bb997dd84eb8a41b419959994b26]: Sch. 2A para. 7(e) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(5) (with reg. 6)

[^key-addf4866e3e599b5c8a9e23ff613de9a]: Sch. 2A para. 13(da)(iii) omitted (17.6.2025) by virtue of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(6)(a) (with reg. 6)

[^key-570fd4f0f593dc4523ca1a100603e8ba]: Sch. 2A para. 13(da)(iv) inserted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(6)(b) (with reg. 6)

[^key-81af355c353df4e3657a37214affca66]: Sch. 2A para. 15(f) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(7) (with reg. 6)

[^key-b6673598cd044ce47ab6e85f51266d70]: Sch. 2A para. 16(e) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(8) (with reg. 6)

[^key-db36988464f5fed609eb70c200a89b40]: Sch. 2A para. 17(e) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(9) (with reg. 6)

[^key-d8e23964c32c86e2406a3370d59e9115]: Sch. 2A para. 18(e) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(10) (with reg. 6)

[^key-19e457c60ee8c00d2bf80f77047407ac]: Sch. 2A para. 19(f) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(11) (with reg. 6)

[^key-97979ce878f6e1819a2d724d20bef55a]: Sch. 2A para. 26(e) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(12) (with reg. 6)

[^key-a73c8f7597898d3dd23a4d71aa1d0bc2]: Sch. 2A para. 27(d)(iii) inserted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(13) (with reg. 6)

[^key-a9004149f38171679425b55c253ab006]: Sch. 2A para. 29(da) inserted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(14) (with reg. 6)

[^key-080d37e1c2465918882f5ed0d0068e97]: Reg. 56E inserted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 11

[^key-6e23a847d339fad773f9a65001f9fe48]: Reg. 58A inserted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 12

[^key-34760def9e1812758927fa65f47ae6db]: Sum in reg. 54(1)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(a)(i)

[^key-93d5e62d5926307d51f4819bcdb1a780]: Sum in reg. 54(1)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(a)(ii)

[^key-239bbbcb8e3132e996dfe3a720d5e229]: Sum in reg. 54(2)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(b)(i)

[^key-cfae8733c9ce2bab398533cb8ad92cea]: Sum in reg. 54(2)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(b)(ii)

[^key-ca8db05db5824da483e499dd21cdc8c8]: Sum in reg. 54(3)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(c)(i)

[^key-90186f2182ea1559b85c4ee010ded1a4]: Sum in reg. 54(3)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(c)(ii)

[^key-d2b5e3be10b3b78ce2dfa65d337ff163]: Sum in reg. 54(3)(c) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(c)(iii)

[^key-976dd07b977128f119b7ad31cc1b6def]: Sum in reg. 54(3A)(a)(i) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(d)(i)

[^key-f168d274a93a0548ad6364db6c49f1b4]: Sum in reg. 54(3A)(a)(ii) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(d)(ii)

[^key-7b86bfe306c173ea16469e910f063776]: Sum in reg. 54(3C)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(e)(i)

[^key-7bbfe63f09b9adc56c747631102bcc60]: Sum in reg. 54(3C)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(e)(ii)

[^key-ae9b0bbf95699b8b12b9bfa73eb81494]: Sum in reg. 54(3D)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(f)(i)

[^key-b307396626ae4a9ac4733ea518acf590]: Sum in reg. 54(3D)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(f)(ii)

[^key-1b4dcd216491fa85bb6dd0d19a7813f8]: Sum in reg. 54(3E) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(g)

[^key-47fe2ecf08a16b2092939f5ea0b050c3]: Sum in reg. 54(3F) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 5(h)

[^key-92cb0846f772c7504dcfe155de03554d]: Sum in reg. 55(1)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(a)(i)

[^key-2f82bce5e4cc4514506612f28c0d35ed]: Sum in reg. 55(1)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(a)(ii)

[^key-1b126c6f08e6af9d7f8645f98869719f]: Sum in reg. 55(2)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(b)(i)

[^key-629a03a258c565ab76591666744d6303]: Sum in reg. 55(2)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(b)(ii)

[^key-c7e274b7494dbdb365715e12eb245259]: Sum in reg. 55(3)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(c)(i)

[^key-095b84bce954f5fe3bf6bfc702a7fdcb]: Sum in reg. 55(3)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(c)(ii)

[^key-44749670542aa6f69128141bda8dbdfa]: Sum in reg. 55(3)(d) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(c)(ii)

[^key-43c24189a75250c7f00fe732a8c98351]: Sum in reg. 55(3A) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(d)

[^key-fe6b5d5cf11d85ede250ab982ec4a7f5]: Sum in reg. 55(3B) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(e)

[^key-de07650a08fe4918cebe623f8749f2d3]: Sum in reg. 55(3D)(a)(i) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(f)(i)

[^key-f398f4790e382c7901b711200595e0e2]: Sum in reg. 55(3D)(a)(ii) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 6(f)(ii)

[^key-d0bdfe0a2a251221600bea53f0b02ec9]: Sum in reg. 55(1)(a) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(a)(i)

[^key-1037da82cddea1ccad5a2763666f4cfe]: Sum in reg. 55(1)(b) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(a)(ii)

[^key-31e6a32baa32be9f4843d0dafc63d3f3]: Sum in reg. 55(2)(a) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(b)(i)

[^key-6b6325dd8834550eb7dca506503b41af]: Sum in reg. 55(2)(b) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(b)(ii)

[^key-5425156b93f1e1d36405847bde09c5cd]: Sum in reg. 55(3)(a) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(c)(i)

[^key-33e10ed2554590d3276edcfa9ae3bb9b]: Sum in reg. 55(3)(b) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(c)(ii)

[^key-6cee3d3f532fb481342ae3557e303b91]: Sum in reg. 55(3)(d) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(c)(ii)

[^key-18da9eff5aa89992bfe29283e66ea0ef]: Sum in reg. 55(3A) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(d)

[^key-3874237cd89711da3b9aba4e656f2051]: Sum in reg. 55(3B) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(e)

[^key-4cf26c50eb591f28ccd34a707a9ce9d4]: Sum in reg. 55(3D)(a)(i) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(f)(i)

[^key-761e6201358a48d3425b46b8554f7f6d]: Sum in reg. 55(3D)(a)(ii) substituted (N.I.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 7(f)(ii)

[^key-d74529d172a7e40f185d39581cc92f0a]: Sum in reg. 56(1)(a)(i) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(a)(i)

[^key-1e6d9acab7632c7acaea7ffe5005eb78]: Sum in reg. 56(1)(a)(ii) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(a)(ii)

[^key-44bd630595eeb2cb5ac932fed4512d87]: Sum in reg. 56(1)(b)(i) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(a)(iii)

[^key-978f37537b1e26a38dc9a35a7ed6f02f]: Sum in reg. 56(1)(b)(ii) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(a)(iv)

[^key-5f95b0a73c674e63048c54a09643677c]: Sum in reg. 56(3A)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(b)(i)

[^key-2726b963aea1ada81802b98c745f1817]: Sum in reg. 56(3A)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(b)(ii)

[^key-3202d3174af148a9babdd2aba5d42326]: Sum in reg. 56(3B)(a) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(c)(i)

[^key-a4c973965cc3d7a0064b3f0a35889524]: Sum in reg. 56(3B)(b) substituted (E.W.S.) (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 8(c)(ii)

[^key-c60fb906bb41895a38739c3726ce3d97]: Sum in reg. 56C(1)(a) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 9(a)(i)

[^key-63e67f3d594307081bac655a355ebeec]: Sum in reg. 56C(1)(b) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 9(a)(ii)

[^key-6511f8e3902344bfa76d7229a771e97d]: Sum in reg. 56C(2)(a) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 9(b)(i)

[^key-fd9fe5e811f2875ae6c21b639a3ea1d1]: Sum in reg. 56C(2)(b) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 9(b)(ii)

[^key-a7c5b6b5ada78afda0f6d0ef2c84c94d]: Sum in reg. 56C(3)(a) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 9(c)(i)

[^key-954f19b218709b17cf5f9514b550f989]: Sum in reg. 56C(3)(b) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 9(c)(ii)

[^key-e4772d5ce1f79233567f96b5329994b6]: Reg. 56D omitted (16.7.2025) by virtue of The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 10

[^key-668672e6616a683bdcadd3d47aaed86f]: Reg. 53 renumbered as reg. 53(1) (E.W.S.) (1.4.2026) by The Medical Devices (Fees Amendment) Regulations 2026 (S.I. 2026/197), regs. 1(2), 3(a)

[^key-ce78f55f898e6f1dedf7e9339c2d9d7b]: Reg. 53(2)-(7) inserted (E.W.S.) (1.4.2026) by The Medical Devices (Fees Amendment) Regulations 2026 (S.I. 2026/197), regs. 1(2), 3(c)

[^key-2ed00c4e5feaf05790ef6b8aa2d8f6b7]: Sum in reg. 53(1) substituted (E.W.S.) (1.4.2026) by The Medical Devices (Fees Amendment) Regulations 2026 (S.I. 2026/197), regs. 1(2), 3(b)

[^key-8408943984fef40bd42c8a5a6bbaaff0]: Reg. 53 renumbered as reg. 53(1) (N.I.) (1.4.2026) by The Medical Devices (Fees Amendment) Regulations 2026 (S.I. 2026/197), regs. 1(2), 4(a)