The Medical Devices Regulations 2002

[^key-13e4d66ad56b8d327005378bc316a99b]: Reg. 21(2)(3) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 12(b)

[^key-13f5fceb24e23519b070b80e975ade18]: Words in reg. 19B(7)(d) substituted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(5)(c)

[^key-14785b52ab6cf681e2f9d2178b50d1b9]: Words in reg. 19(1)(b) substituted (N.I.) (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 34(b)

[^key-159219ca5ae1f712ce6a1004972aff69]: Words in reg. 54(3) substituted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 16

[^key-15c95eded80b424adb7cf51449971ac1]: Words in reg. 49(3)(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), 7(9)(e)(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-15f4327f79e0fee06f6e8a9de725cd1a]: Regs. 34A-34C inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 5

[^key-17e3806ce1021b9f93e166c38105db0b]: Reg. 30A inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(8) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 34); 2020 c. 1, Sch. 5 para. 1(1)

[^key-184bad1ac34394cc6f6d562cb6c792d5]: 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)

[^key-1938321165d882757672af1d417802cc]: Word in reg. 49(4) 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. 19(f)

[^key-195c44e1d97411cd5c1946e420a5781c]: 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)

[^key-19753a0a8264dae9630c7c9d18f93d6d]: Words in reg. 48(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), 7(8)(c)(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-199923eb655fc182597f43c7fe2903e3]: Words in reg. 55(3) 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. 21(c)(i)

[^key-19bcaa2a603984aed38b8d5dbf424f08]: Words in reg. 59 omitted (E.W.S.) (30.4.2021) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(2)(e), 9(2)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-19c644994dd0abd5fa98057076885894]: Words in reg. 30(2) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 14(b)(ii)

[^key-1a1bdcdd68accb5272faedf18162e9a5]: Reg. 21(3) 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. 11(b)

[^key-1a8737e5c535d51d2d1ae2d626c3630f]: Words in reg. 19B(3) inserted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(3)(a)

[^key-1aa9200453f20e51250ff9c77cfd629d]: 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)

[^key-1b1c81b5b486336267f78eb35526d0f7]: Words in reg. 24(3)(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-1d71ce0dc9822f3466ecafbf26fa6a37]: Words in reg. 20(1)(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 10(a)

[^key-1e008479dc6ba98e3bf761e9da39fb22]: Words in reg. 17 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(8)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 21); 2020 c. 1, Sch. 5 para. 1(1)

[^key-1e6bcb00259d36f19c40a960709616c9]: Words in reg. 45(6) 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)(j)(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-1e8b5b8ea05f35fda61e1d46a4488e84]: Sch. 2A para. 15(zj) inserted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(g)(i)

[^key-1fdc546cb4c748193b7447f0235d15e8]: Reg. 44ZA(3A) inserted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 9(4)

[^key-200e99357689d468af6631c59ff4e5c2]: Words in reg. 45(1) inserted (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. 16

[^key-20b28ef399498ef66266965ccb2e6e12]: Words in reg. 48(8) 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(8)(h)(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-20c57b656dd28a3e41078abc724ba60e]: Words in reg. 39(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(5)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 40); 2020 c. 1, Sch. 5 para. 1(1)

[^key-2168d907df39b552c43043a8b2db75cb]: Reg. 60 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), 9(3)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-223b37e1c4fe9d7e1e15f66675765cd6]: 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)(f) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(e)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-23aacc119a8dc4883e3f2a5fb3cde6b3]: Reg. 4N omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 6

[^key-23da3c75b86433e346aa9f4be48561fe]: Reg. 17(3) omitted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(8)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 21); 2020 c. 1, Sch. 5 para. 1(1)

[^key-24bfb31497548afcefff398381b034c3]: Word in reg. 55 heading 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), 8(4)(a) (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-24d91a53d1b41700dadab6c013fb6376]: Reg. 44A inserted (1.9.2003) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 12

[^key-254aabecfa08252cbd2f85e2cec57f1f]: Words in reg. 61(2) 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. 24(b)

[^key-255607aa1eb8de52550d0e6f2f389343]: Words in reg. 15(a) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 5

[^key-25d035a5cce8c403e0a8f8b6f79fc221]: Words in reg. 41(1) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(6)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 42); 2020 c. 1, Sch. 5 para. 1(1)

[^key-25e0172df3f3cdee7b7f8eacd3085243]: Regs. 44ZA, 44ZB inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(10) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 46); 2020 c. 1, Sch. 5 para. 1(1)

[^key-25ea4eee0db7692406e6b659b14a0b4e]: Words in reg. 55(1) 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. 21(b)

[^key-264a205b1f0507af4ce872b959433e3b]: Words in reg. 51 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(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-2773be711f2becd75e4cc3abe1b6bf0b]: Reg. 61(1A) inserted (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. 24(a)

[^key-2776a074be205515160b880fb4758757]: Words in reg. 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), 3(3)(r)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 4(k)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-284424b7b91fece660023aae2d6e9c55]: Words in reg. 47(3) 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(6)(d)(iv) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)

[^key-28683d509f19fd5ad5368a85ca9aed48]: Words in reg. 10(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(6A)(e)(ii)(bb) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1)

[^key-293acaae806b8c707d586dab8c261599]: 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)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 42); 2020 c. 1, Sch. 5 para. 1(1)

[^key-29ab7cee83dd4085a7a67dc1ecaefb49]: 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)

[^key-29c108245a1844d8425b90328059d2b3]: Words in reg. 19B(1)(a) omitted (E.W.S.) (1.7.2023) by virtue of The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(2)(b)

[^key-29e9271dd4e66d833fe0fd957038a3a2]: Words in reg. 2A(2) renumbered as reg. 2A(2)(a) (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 31(b)(i)

[^key-2a2f4f4c6c9e75912223c47575fc8adf]: 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)

[^key-2a55df50493c23149118d4855aaa8236]: Reg. 39A inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 8

[^key-2b3d51124d8cde595fd85315373466f9]: Reg. 24A inserted (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. 9

[^key-2be6fd3f0d82e13baa3f79b0ad029e24]: Words in reg. 47(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), 7(6)(c)(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-2d8889e4cb5277f41c87b3520c445ba1]: 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)

[^key-2dc058f2952969d9056b0aa3654d3331]: Word in reg. 45(2)(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), 7(4)(d)(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-2e97f7998962778cddaa5ce538ddbb5f]: Words in reg. 16(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(7D)(c)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 20); 2020 c. 1, Sch. 5 para. 1(1)

[^key-30fbbf828c621839beb30506c23cac80]: Words in reg. 49(1)(b) 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. 19(d)(ii)

[^key-30fdf6516b10a11a75db54e4d0b940d2]: Words in reg. 46 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(5)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)

[^key-3121bab9e1b79364c60298be0c3ab58c]: 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)

[^key-31546089ea7d479dbfc3fcaa224ce1aa]: 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)

[^key-3252e2de2ba30b1333d50d26b82074b6]: Regs. 3A, 3B 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(6) (as amended by S.I. 2019/1385, reg. 1, Sch. 2 para. 2 and S.I. 2020/1478, regs. 1(2)(3), 4(2), Sch. 2 paras. 2, 8); 2020 c. 1, Sch. 5 para. 1(1)

[^key-33abe13283a070def13ffaf23a8f5163]: Words in reg. 19B(3)(f) substituted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(3)(c)

[^key-33fdb74275cd927bf22f56bcd1f36bc1]: Reg. 61(1A)-(1C) substituted for reg. 61(1)-(8) (26.5.2021) by Medicines and Medical Devices Act 2021 (c. 3), ss. 41(6), 50(3) (with s. 41(8)); S.I. 2021/610, reg. 2(c) (with reg. 3)

[^key-34524b74839c1021b2b1b5b612cdb334]: Sch. 2A para. 3(g) substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 21(c)(iii)

[^key-34a18eaa1c1b78742885ac4e643ac4d9]: Words in reg. 10(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(6A)(e)(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-36514e66e11dd4aa0524f731a721109a]: Words in reg. 48(1) 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(b)(ii)

[^key-37ad3f2ebe6db4b5d838e44530cfc05d]: Regs. 44, 44ZA substituted for reg. 44 (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. 15

[^key-37ce048ea74df8b015795f7cf8e9906c]: Words in reg. 31(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), 5(7)(b)(iii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 33); 2020 c. 1, Sch. 5 para. 1(1)

[^key-3842195729cc98e1cd29ca3140b0bf0a]: Words in reg. 47(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), 7(6)(c)(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-385eea91aa87516611cb7ec28b8bf938]: 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)(h) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-38ac96a1481625139c824909988050bc]: Words in reg. 45(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), 7(4)(c) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)

[^key-390ac97471213d6a29b3e2e7591e37cf]: Words in reg. 18(1)(b) omitted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(9)(b)(iii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 22); 2020 c. 1, Sch. 5 para. 1(1)

[^key-391d48a58522cdd65c741bbd096bc2ad]: Words in reg. 28 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(5B) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 30); 2020 c. 1, Sch. 5 para. 1(1)

[^key-39397e20a427b56ffb6ff9ea311ef489]: Word in reg. 6(a) inserted (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. 8(a)

[^key-3a7ab65ef13f3470284eff4da3fb7068]: Words in reg. 60(3)(b) 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(c)(ii)(aa)

[^key-3b94ff87e1bded39af8de0a1a43729f4]: Words in reg. 50(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), 7(10)(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-3c61ff5a23235d5fe6ba4172aa919fcb]: Words in reg. 48(6) 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(f)

[^key-3d9ea61f1c81694c4398f8e97eb97af1]: Word in reg. 67 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(8) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-3dac9cb17fd2ecfb38730320f7728b35]: Words in reg. 2(1) inserted (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. 1(c)

[^key-3dfbed4d6b8dea4b242790cd6d0dffd3]: Reg. 47A inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(7) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47(7)); 2020 c. 1, Sch. 5 para. 1(1)

[^key-3e0021d73537f884543e7899ff01fca9]: Words in reg. 40 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), reg. 6(5A)(b) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 41); 2020 c. 1, Sch. 5 para. 1(1)

[^key-401291d31175eb7e16c64dddf9158654]: 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)(Ii) (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-40af47a53bd853b672cc41d927fb3190]: Words in reg. 60(1) 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. 23(a)(i)

[^key-40c894aed7cd94a7cd1b59f94607cae2]: Words in reg. 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), 3(3)(o) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-40d04f5be0dc10e3e1a11aabd1f7770f]: Words in reg. 19B(1)(a) inserted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 6(2)(a)

[^key-40edf50161a7376ec06f3d8fa4572b06]: Reg. 8(3) added (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 5

[^key-41231059fab2e2504a6b22e484ffcfdc]: Words in reg. 10(2)(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), 4(6A)(c)(iii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1)

[^key-4134bb1c7db4382e211746d76f30e5cb]: Reg. 12(6)(7) inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(7)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 16); 2020 c. 1, Sch. 5 para. 1(1)

[^key-41b8d91710a37e6edd4184aad9de718b]: Reg. 4T(2)(b) 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(a)(i)

[^key-41bf22d4e5d6d9633dbefb347fb65be0]: Words in reg. 21(1) omitted (E.W.S) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 11(a)

[^key-41c3ff483063ca319edb58a580def5c9]: Reg. 2A 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(4A) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 6); 2020 c. 1, Sch. 5 para. 1(1)

[^key-4450714f4530d9cbb521d66985eb669e]: Reg. 23(3)(b)(ii) 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)(b) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-453481203028dae0060059f5fdddd3f1]: 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)

[^key-469b6c7709e6c1a1aa6ee86bcb18ab64]: Words in reg. 14(4A) 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)(a) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 18); 2020 c. 1, Sch. 5 para. 1(1)

[^key-4778b4a76f36c99f429d2646e99cd354]: Words in reg. 10(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), 4(6A)(d)(ii)(bb) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 14); 2020 c. 1, Sch. 5 para. 1(1)

[^key-48046710bc33e1083a209d6aebaac18f]: Words in reg. 2 inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 3

[^key-481e21e8e6157badbcfcbd9bfc917cbf]: Reg. 9(5A) inserted (21.3.2010) by The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 6(a)

[^key-482aa68831708b49e0bd16209b0e1804]: 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)

[^key-486839a141fb8b8a9ae3a747c4e445c8]: Words in reg. 3(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), 3(5)(c)(i) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-48cc0bf75579e9d355d64ee4cacbbbd6]: Regs. 19B, 19C inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(11) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 24); 2020 c. 1, Sch. 5 para. 1(1)

[^key-498c260a12b01840a757f1b4c634e8e2]: Reg. 56(3B) 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), 13(2)

[^key-49b46fdc04fef602f3ac182b55fda4c6]: Words in reg. 2 inserted (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. 2(g)

[^key-4a00133919ae8ffaf2b6405267bef7ce]: Word in reg. 33(2)(a) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 16(b)(i)

[^key-4a2ca3c60cc54bf7c161eff81ceb5a83]: 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)

[^key-4ad737077025bc412ab3fa5f3ac400ed]: Words in reg. 8(1) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 3

[^key-4c63ec1a1901fae0d0c3555e809fa361]: Reg. 21(4) omitted (E.W.S.) (11.8.2021) by virtue of The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 11(c)

[^key-4c693c96d951e5ea0f950b40f6a50bb9]: Reg. 19C(3)(ba) inserted (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 7(2)

[^key-4ca7651bd7c6a426539d25838679b4bd]: Words in reg. 18(1)(a) omitted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 4(9)(b)(ii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 22); 2020 c. 1, Sch. 5 para. 1(1)

[^key-4cf570e94746881e14b6b809195c00a5]: Reg. 27(d) added (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 11(c)

[^key-4dc1c7ef7c1c85217762e9905ba45e82]: Words in reg. 48(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), 7(8)(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-4ef50b32cffb363b6940bbbce2b9dd91]: Reg. 60(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), 9(3)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-4ef516c8e55bee7bb243951d190c5068]: 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)

[^key-4fe83105848c988b3a0372f16d89d7dc]: Words in reg. 44ZA(3)(f) substituted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 9(3)(c)

[^key-50fa857c7e82b7723991ca071a557123]: Words in reg. 47(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), 7(6)(d)(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-5134f9e5cae937e5fd41577a0c0a0589]: Words in reg. 32 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. 15

[^key-529406612f91947a21c13adf63972fad]: 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)(r)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-529dbd18a7dfcdaa7620d6db08687168]: Words in reg. 60(3) 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(c)(i)

[^key-52cd832a547ca7685a07591eab26103d]: Words in reg. 49(1)(b) 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. 19(d)(i)

[^key-530a4b10f3a58141d524facbce2d2d40]: Words in reg. 29 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(5C)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 31); 2020 c. 1, Sch. 5 para. 1(1)