The Medical Devices Regulations 2002

[^key-f1c651e9c905c8bb8d2cc994700b5ea0]: Words in reg. 9(4) substituted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 9

[^key-f1f518d3889388deeae07fdd3b23cf96]: Sch. 1 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(9) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-f26d898c8afe145749885d50e5bd8536]: Words in reg. 45 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(4)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)

[^key-f27ad25696d09ff09dac7348c40ab625]: Words in reg. 51 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(11) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)

[^key-f28f4188621dc457a10df5ff37bd715c]: Words in reg. 54(3D) inserted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(7)(c)

[^key-f3344a6c34f9ba57ad5567a878922b22]: 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)

[^key-f40709cc1b0af67fe6f0e5e3f240fafe]: Word in reg. 13(4)(b) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(a)

[^key-f453e016c881fa5e92a81c54fda7650f]: Words in reg. 2 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(3)(aa) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(a)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-f45940b1059baad32c563cf01b7163d5]: Words in reg. 59 omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 17

[^key-f5c035b6f1473d530bbf26a02da086ad]: Word in reg. 48 heading omitted (N.I.) (31.12.2020 immediately before IP completion day) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(a)

[^key-f6abdcab2cc67383e36b7c6ecb11303c]: Words in reg. 54(3D) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(3)(e)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 48); 2020 c. 1, Sch. 5 para. 1(1)

[^key-f806039f6b6b090009325b78cf8f74ea]: 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)

[^key-f822cf94e242d3d05b61ce1bf6d0046a]: Reg. 1ZA substituted (30.6.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(1), 4

[^key-f8946206fe965b41b5d8ad5adb0b97a2]: Words in reg. 2(1) inserted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 4

[^key-f91c720238ae05ca3266038c396256f9]: Reg. 44ZB(3)(ba) inserted (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 10

[^key-f989eef9dd476125d3abadebf3867003]: Words in reg. 23(3)(b)(i) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-fa0e8e35a8ed1df39d10d68dcaa5df74]: Words in reg. 48(8) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 18(h)(ii)

[^key-faa55f34e46687f322e4190ab9edc759]: Word in reg. 48(6) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(8)(f) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)

[^key-fad086d034d351aa1c8bbbc429083491]: Words in reg. 27 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(5A)(b)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 29); 2020 c. 1, Sch. 5 para. 1(1)

[^key-fad8e5beaa4153f50f078352392560c2]: Words in reg. 4T(4)(a) omitted (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 7(b)

[^key-fb14a6c53511650bdb855bf7ed6dd719]: Words in reg. 65 substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 26

[^key-fb8f24f5bb0e50624840bf058bf8d9c7]: Words in reg. 16(4) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7D)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 20); 2020 c. 1, Sch. 5 para. 1(1)

[^key-fbda3fa023caa224da58534a21a28e53]: Words in reg. 24(4)(b) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4A)(d)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1)

[^key-fc0e0ea27954c89fd40e0f3bf026f1b1]: Words in reg. 13 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7A)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 17); 2020 c. 1, Sch. 5 para. 1(1)

[^key-fc5c5f3955007b76e4063268e10a44ae]: Words in reg. 3A(5) inserted (31.12.2020) by European Union (Future Relationship) Act 2020 (c. 29), s. 40(7), Sch. 4 para. 1(c)(ii); S.I. 2020/1662, reg. 2(ee)

[^key-fc5e88cbff1a507d4dc8ec562c4d5221]: Words in reg. 41 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(6)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 42); 2020 c. 1, Sch. 5 para. 1(1)

[^key-fc64f5e6388d81836adfb6f138c39f9a]: Words in reg. 10(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6A)(c)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1)

[^key-fcbc3e101f1f9b84c4f650112b67cce5]: 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)

[^key-fe2ce373a45ffbed1480765e6a7ca793]: Words in reg. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 3(3)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-fe32e57b03ceab38afa0ceb755ef76d0]: Words in reg. 55(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(4)(c)(i) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 7 and S.I. 2020/1478, reg. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-fe3faadd0671955289484e7c594f5a37]: Sch. 2A para. 3(e)(iv) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(c)(ii)

[^key-fe52288ed4c2a411eacbac2a2acec317]: Words in reg. 47(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(b)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)

[^key-fe8fef42fe5f1aafb8626d20db625ea3]: Reg. 2(1B) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(6)

[^key-ffe06c1812c24834d157d3ab34556fb5]: Reg. 54(2) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 10(3)

[^key-ffef6f4a57b9ca90ef32a62b57ec6018]: Words in reg. 47(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(6)(b)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)

[^key-fff03a3efd8147e8b95ad9a1a959fc93]: Words in reg. 2(1) inserted (1.9.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(b), 2(b)

[^M_E_1b1f39b8-98ae-4d72-ba73-68d5797fa7f9]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_1fdcfc3b-bfe8-4b5c-d02d-a18e0e10fbbd]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_2333354e-c964-42b1-c2bc-d08ec96e4552]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_24a35cc5-5887-40db-bb8f-4497fb90a737]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_265216b9-382e-4f1c-f3ea-c49f63b2845e]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_2ac9e6c1-12c1-4f7d-af3d-faed7dc7f575]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_2f511d06-ebcf-46c2-c41a-89e8622f3072]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_36d0b908-2151-4c23-ccd1-b4debf89fb7a]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_3f044054-ff8c-4549-e4e4-3b5bd0d74603]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_404224d9-7eda-4bea-a10a-293d14a7a86e]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_42f89574-2304-40d1-ef2c-12f80e3ce13b]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_444cf10b-a777-42ea-d483-2a615232411f]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_4611b97f-5850-4285-dee8-17962b96875b]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_4673df8c-5312-432d-cd49-af60ba12b610]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_4ac0a8c8-7022-4cf9-bdf3-83ab7ff2f69a]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_4df4ebad-d5da-43f5-8683-565ddb996ad5]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_50b86a9d-fbd3-4cb1-d36f-4b542aac13e9]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_5626ee41-cdb4-4609-fcbd-f31b6b966241]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_56467835-f67f-4777-a90b-1d636f638891]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_599b3ac2-ea91-419e-fc96-8085ef37da6a]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_614125e5-f46b-4024-fb1d-1bdea1ac7f54]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_649e8d6c-635a-4784-aefb-cc77ccd3f0f3]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_6a44ff7e-d9f6-454c-b21b-563bbceb03fe]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_6a63af84-827c-42ea-da29-b48fb56c548f]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_6b2e68d1-fbc1-422a-d3fd-7f8325ba19d0]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_6d7d3de1-20b4-462a-be64-2bf3f3d39f1b]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_6ef5d008-96a3-4e1c-9b2f-0454a43416b9]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_71ff695e-08e5-45bb-f9eb-0ea76f865ece]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_74d91690-b3bc-4e35-de23-bd09957d5bac]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_753540e3-f080-492b-d92a-785a43e6617b]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_75cdd9c3-d6a7-4d7d-ab56-bd3201b12572]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_7fa30b0d-8298-49a4-f21a-f6c4dc4c7694]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_8028548b-b636-4f05-8586-b9bfd2b25cda]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_80e4f1d2-0db5-465f-e212-a6011fb47ed7]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_8137b11c-ecbc-4ef6-c549-ed1660e57cb9]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_84b0c119-9efa-4ef2-e85c-3106b0b57752]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_855db655-938f-4aa0-e7e5-19d9a40d3ae3]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_86e3f613-fafa-481a-e798-f5c2acc8daab]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_874b93ad-4165-443e-aef1-280e67572ad0]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_8ac31a15-3ee0-4d2c-a012-c4df05d8ba42]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_8bb76672-2d33-4d4b-fb99-184af0202a4f]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_8ddd7ee5-1137-4dae-d45c-ec96dfd9338e]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_9139da87-7453-4a58-8e29-64d5ef3796a7]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_91c5989a-6680-4449-dbb2-131fc0497d04]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_93c170ad-a9e2-4fa3-c319-9fba223d5697]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_959e1b81-8558-4f76-9b5d-33e722650f8d]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_9967c42d-5596-4f6b-de7d-60b7d6db7a8a]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_9b0950bf-9faa-4bd3-ad39-084ceaf9c6ed]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_9b4b4e73-f1ec-4820-c91e-5d88440399e9]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_9cdecb5d-5f74-4d9d-d118-f0a97416b753]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_9e71b00a-0c06-45e0-f065-f72c5c0fd0c5]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_a3891a9d-c3d4-4e17-fc5e-f198c2a2a71a]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_a4739a97-909c-4790-b540-80430c7ee996]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_a557d3a1-7f76-4d95-b586-2fb802190f68]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_a73921dd-bbcb-4471-e132-1b7e54f08f26]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_a7fdda3f-f559-456d-c7b2-3416e4dd7819]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_ac2ded94-14bc-4cb5-8bb1-06cb14290174]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_ad2aed32-3512-4095-ffbe-9021efcfb4f1]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_b07eae73-73b7-4f2e-d1ef-2ff658fa32d3]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_b3048b28-1c79-44b2-8edf-b243662feca6]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_b4a97e75-487e-4c22-d583-af4dc5fb2c67]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_b4e853a7-41db-4486-f33e-3a8a690a5b48]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_b6a1c363-a6bd-47a2-a27f-4d6dd8409504]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_b6b93503-04b2-45c8-9a67-4dc79de6ed60]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_bcf320bf-d50a-4c65-c84f-f26488551ca1]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_bde984cb-9037-4297-b302-f9d61b191839]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_be46cf14-e920-4e6b-ab6c-403c94f8aad6]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_c1d7cef2-40eb-42c3-e88b-e0c8e10bfab0]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_c1fbb7e5-5302-4ba3-c257-86f718561b3f]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_c4f406a1-e574-4f8f-a74b-6a2a0194fe8b]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_c5118cf4-81b4-4606-d4e2-355d1e70a9de]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_c5d084ed-cf2d-44e2-90e4-5ffbdcfd432a]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_c7c9520d-b7ec-4ea6-8c6c-44caa886a851]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_cb168b7b-4ad6-49c0-b3fc-6c9764f122a6]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_cddd11e4-f0b6-4443-8f00-e0517aef0d6e]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_cf88a546-7fa7-433a-94a6-cf9a4b903b3b]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_d2536e53-334e-4473-b111-30ec4cda1502]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_d3ab7c91-3719-42ba-a367-0289f916e0b8]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_d67ba951-5c29-4a03-fd87-468f1e38489c]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_d7389e3a-9f43-4295-d369-1b2f46da51ac]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_d84549da-0178-4fda-d381-7c9bbfe697e9]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_da7ce1c6-263b-4033-9daf-b133c0c11f83]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_db12c817-af5f-4f52-bf9a-e6203e717825]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_e107e4fe-51e1-4cc0-fabf-f279ad4aab8c]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_e256cee2-e40b-4508-cdd7-50edbf23ba8e]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_e6cf1992-d626-406a-feb7-66ed11fcbf9e]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only for the substitution of Sch. 2 in relation to E.W.S. (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(10) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^M_E_ea051e25-4bb6-43e9-b71f-4277484c2390]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_ea12080c-0e2c-4673-efff-ab8e42576a2b]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_ec0484e8-6635-4cf0-95ad-315dc6e55b0d]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_f0f4689c-d6cd-42f0-a35f-ca079937794d]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_f2deb5cf-b7f4-4fd4-ee09-e3e6fcc54490]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_f3795d0d-efea-492e-891f-13b0ee1e21aa]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_E_f3f01a95-bbd3-4503-a6f9-0f226a502615]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_f6ff2c73-8476-448f-bd04-216a23b90866]: This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[^M_E_fca8c960-fac7-4c00-e0d6-9731b05b78de]: This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

[^M_F_1aab245d-99ef-433f-911e-636441cf8a28]: Words in reg. 40 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(5A)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 41); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_1c5f4fd8-c713-4446-e075-b4b4980eecc5]: Words in reg. 42(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(b)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_1da332f8-3ff5-4f62-d57f-fa1df74b10a9]: Words in reg. 42(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_212dc644-b6ca-4225-8d6e-095d41a174f8]: Words in reg. 42(1)(c) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(b)(iv) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_26e6504e-6d4a-4ef7-bfd6-b9dfab985d00]: Words in reg. 9(8) omitted (E.W.S.) (31.12.2020) by virtue of y The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6)(ab) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 13); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_297d2b0c-6c44-4983-9d10-ce4348a5847d]: Words in reg. 42(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(d)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_2ce1ce56-5595-40ca-88d0-feaf03ea8403]: Words in reg. 42(1)(b) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(b)(iii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_4018d5d1-ceb9-4395-dc1c-09281cbceab9]: Words in reg. 42(1)(a) omitted (E.W.S.) (31.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(b)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_4630696b-e5c2-4f5e-b7a5-08f696612124]: Words in reg. 42(3) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(d)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_509c63c8-4471-40be-bed8-6e6d79140d57]: Words in reg. 60(2) substituted (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 23(b)(ii)

[^M_F_5a9e3bf3-15ae-4f49-e4d6-1f62018ebb99]: Words in reg. 9(9) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6)(b)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_7d30bf50-564b-43fa-c44f-8b8819b8c4e9]: Words in reg. 42 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(7)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 43); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_852f0545-028d-4833-8028-1ca1e9c52add]: Words in reg. 9(9) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(6)(b)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_8ad37e1f-8be4-4807-a2ef-aed586f60136]: Sch. 2 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 9(10) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_da3152ae-c8dd-4193-d3f4-c5755e072efb]: Words in reg. 14(5)(a) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7B)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 18); 2020 c. 1, Sch. 5 para. 1(1)

[^M_F_e34b8ac2-d592-4fc5-c531-fcfc66f54326]: 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))

[^M_F_ea212954-62e0-44a9-ff58-eb368c9a9e43]: 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))

[^M_F_ff6ca096-69b5-4354-dc19-9ff8f8f2b09a]: 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_05a368e0-d53a-d536-7757-53616d2d563a]: 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)(i)

[^V_NI_064bbe01-3538-ae44-b845-85a2764ca306]: Words in reg. 29(1)(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 13

[^V_NI_07922390-92fa-07a8-b77f-80660904b76f]: Words in reg. 61(8)(a)(i) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 17

[^V_NI_09643462-9642-27f2-2db3-c43e6f47ddd8]: Words in reg. 2(1) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(d)

[^V_NI_0b20b1f7-4fda-fc55-0124-98a9e0dff594]: Words in reg. 45(2)(b) inserted (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 13(a)

[^V_NI_0f8fd2f2-b58b-f4ca-100b-3c2066c61285]: Reg. 3(g) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(d)

[^V_NI_1133a35a-2edd-7dc4-8a0e-241f33413073]: Words in reg. 47(4)(5) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 16

[^V_NI_14ac41ca-b630-39c9-eac3-9d412aa3c7cf]: Words in reg. 2(1) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(5)

[^V_NI_14b4f989-1960-8c1c-5d59-b016c555a188]: OJ No. L 311, 28.11.2001, p.67.

[^V_NI_19230b38-a875-499d-6a33-ff504ebe1023]: Words in reg. 60(1)(2)(3) substituted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 17(a)

[^V_NI_1933053a-ed4c-7b1a-b8ae-6830ffd792f4]: Reg. 21 renumbered as reg. 21(1) (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 12(a)

[^V_NI_1a5cf2c1-6c6c-bdf8-7a0f-1f9fecf8226d]: 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)(d)

[^V_NI_1a74a4b8-80d8-877a-859d-6401c7abdaaa]: Reg. 3(e) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 3(c)

[^V_NI_1b7b0348-40de-919f-9aa0-1428ad5325bf]: Sums in reg. 56(1)(b) substituted (1.4.2013) by The Medical Devices (Fees Amendment) Regulations 2013 (S.I. 2013/525), regs. 1, 2(2)(b)

[^V_NI_1b9b854c-4104-0b4d-54a8-e79adb1373ce]: Words in reg. 7 inserted (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 5

[^V_NI_1bcb19c5-137f-52b2-d0d9-e5993ddcf9ac]: Sum in reg. 55(3C) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(f)

[^V_NI_1c861519-80bd-3353-db57-9c2c47aaf974]: Reg. 14(4A) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 7(b)

[^V_NI_1de6ac46-1237-fc8d-d38b-826bb4ac5597]: Reg. 15(e) and word inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 8(2)

[^V_NI_1f5bf580-52d6-08f6-8cbe-abf604fabe46]: Word in reg. 13(4)(b) omitted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(a)

[^V_NI_20008090-6276-3bf6-266e-a776cdc26742]: Words in reg. 61(1) revoked (20.6.2003) by The Enterprise Act 2002 (Part 9 Restrictions on Disclosure of Information) (Amendment and Specification) Order 2003 (S.I. 2003/1400), art. 1, Sch. 5

[^V_NI_2165cc2e-ea3e-aa8a-5d34-6bf4136ac415]: Words in reg. 45(7) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 14(4)

[^V_NI_24d26de5-0f4c-9c4a-e493-cdfb9e7993ee]: Words in reg. 18(1)(b) substituted (21.10.2013) by virtue of The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 8

[^V_NI_2623977d-1a53-4286-6f83-50a64a25a98e]: Words in reg. 61(3) omitted (22.11.2005) by virtue of The Medical Devices (Amendment) Regulations 2005 (S.I. 2005/2909), regs. 1, 2(a)

[^V_NI_28cf59ae-a9f0-8659-a945-e71b1e6ae3bb]: Reg. 16(11) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 9(b)

[^V_NI_29489d93-0d6b-b0b5-72dc-44b9a210f318]: 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_2c9df95c-cad0-8adf-e1f0-e9118c3cd18e]: 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)(a)

[^V_NI_2d7ecc06-fa04-c59d-8701-af5294e77e8f]: Sum in reg. 54(2) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(3)

[^V_NI_2fdfcc50-66e3-10e2-97a9-d4ee447cc225]: Words in reg. 2(1) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(3)

[^V_NI_302b0528-589e-2b54-2af6-0a5b2b714f09]: Reg. 54(3C)-(3E) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(6)

[^V_NI_37ca6c9c-f84a-b69d-2b36-5959794cb31d]: Words in reg. 54(3) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 16

[^V_NI_39aed9b3-2a41-aab6-3167-8348d9ee633b]: Words in reg. 32(1)(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 11

[^V_NI_44c38eef-4840-c299-f300-7081f0244bcb]: 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)(e)

[^V_NI_44cd1a00-e720-314b-03be-a367f092502d]: Words in reg. 2(1) inserted (1.9.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(b), 2(b)

[^V_NI_47163f78-b7af-eae5-ca40-966a37a6aa29]: Sum in reg. 55(3)(c) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(c)(iii)

[^V_NI_47614b7e-f8c8-237f-b942-47a6c3ee44c7]: Reg. 54(3A)(3B) 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(2)(d)

[^V_NI_48fdd643-b60b-3134-3ea3-75c6eb8ab913]: Reg. 9(9) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 6(b)

[^V_NI_4a3d238c-8641-06ac-a211-3cf3200af9c7]: Words in reg. 2(1) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(e)

[^V_NI_4a65297c-fb05-994f-e229-d7fb9d0480b8]: Sums in reg. 55(3A) substituted (1.4.2010) by The Medical Devices (Fees Amendment) Regulations 2010 (S.I. 2010/557), regs. 1, 3(3)(d)

[^V_NI_4e3dc5bc-1191-af26-425d-e47b5eafba88]: 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)(b)

[^V_NI_4f2cde4f-ab67-1f56-2b9d-68019c384938]: Council of Europe (ETS No. 164), Orviedo, 4.4.1997.

[^V_NI_5697aad2-cbb4-e3ec-c4aa-abce3eef8b0d]: Reg. 13(4)(d) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 4(2)(c)

[^V_NI_5a2cee2c-1f65-cd23-05cd-d3f1127490be]: Words in reg. 2(1) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 2(i)

[^V_NI_5aa83adf-02fd-7202-83e2-ef87abd702df]: Sum in reg. 54(3)(c) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(4)(c)

[^V_NI_5cefa5cf-650f-4b43-16dd-b314a9af081f]: Reg. 54(5) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(8)

[^V_NI_5d226121-53ad-3745-e40a-5d193b45c4b1]: See section s 11(1) and 45(1) of that Act.

[^V_NI_5e26117c-a5f0-88bd-160a-be6e897119f1]: Word in reg. 15(c) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 8(1)

[^V_NI_5e3a63a8-4c67-fbb8-d725-af30ebdda50b]: Words in reg. 2(1) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 2(4)

[^V_NI_63851776-842d-42b2-fbd6-4b758c35c13a]: Reg. 55(3A)-(3D) 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)(d)

[^V_NI_64748380-a08c-a136-95d5-854d49e7347c]: Words in reg. 8(2) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 3

[^V_NI_676fffe3-3784-265e-e438-b0351eee380a]: Reg. 27(d) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 11(c)

[^V_NI_69191062-b8e2-eca7-39a8-043357b4845a]: Sum in reg. 54(1)(a) substituted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 3(2)(a)

[^V_NI_693c078f-1678-9b0e-d398-b18943f4ceb9]: Reg. 54(3)(a)-(c) substituted (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(2)(c)

[^V_NI_6a0d965f-4113-a51a-067b-81a95820e082]: Reg. 61(6) substituted (10.3.2007) by The Medical Devices (Amendment) Regulations 2007 (S.I. 2007/400), regs. 1(a), 6

[^V_NI_6b026217-f7d5-e8c5-55f7-ce264dfe58c1]: Words in reg. 54(4)(a)(i) 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_6d49408f-954a-f4e2-778d-2ea383613ac3]: Words in reg. 8(1) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 3

[^V_NI_6dd8cb6a-9081-1a0d-4097-28521b9e18b9]: Reg. 21(2)(3) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 12(b)