The Medical Devices (Northern Ireland Protocol) Regulations 2021

[^key-8368f6879b6154cd2a21d4718ef59796]: Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(ii)

[^key-c5f95690e6871fab6a6c87fcc5625863]: Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(iii)

[^key-42be2110502a077884d7c9feeb313ac6]: Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(iv)(aa)

[^key-8623e6620e22bd2d10b14405d44fafad]: Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(iv)(bb)

[^key-df06d7e180543e629467efda31ecd910]: Words in Sch. 2 Table 1 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(a)(v)

[^key-7c44be263728f35c8089bef9a60ad317]: Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(i)(aa)

[^key-54a7881e6a4d3a3e9602c3f4912b1dc0]: Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(i)(bb)

[^key-06b85a6f570bf265651559b73f987910]: Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(i)(cc)

[^key-a74a4a3f545e63548a39a78e18ca1b76]: Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(ii)

[^key-5256c738cfdf1c7e9492020d9ec2f5b3]: Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(iii)

[^key-ab5283e149e3773caf924280ab7b3144]: Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(iv)(aa)

[^key-3f1ed50243b6838d0f0003f914a2b37c]: Words in Sch. 2 Table 2 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 43(b)(iv)(bb)

[^key-af284e53c1eed313d26c2e8eaa4148b4]: Sch. 3 Table 1 substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 44(a)

[^key-cf6d9d123b241a04dd76bb6a82bb7171]: Words in Sch. 3 Table 2 substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 44(b)(i)

[^key-99e70cdf1755d70fa07c07a761a8387b]: Words in Sch. 3 Table 2 substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 44(b)(ii)

[^key-6ec0db027e576af77b2a758160a01d78]: Words in Sch. 3 Table 2 substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 44(b)(iii)

[^key-7afeca309d653b6a24213c0e37f109f5]: Sch. 3 Table 3 inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 44(c)

[^key-4cb75f3fbc4c4d2c202b04b4dd5e8adf]: Word in reg. 2(2) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 28(a)

[^key-2b9d9f11ac93da360123a54d0f4b827b]: Word in reg. 2(2) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 28(b)

[^key-0d6885683b60310c4969c9f66d5a01b0]: Words in reg. 3(1) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 29(a)(i)

[^key-497e4c585fe0ec75b1e711b249017505]: Words in reg. 3(1) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 29(a)(ii)

[^key-2226258d5a3cc430a7f22571345aff10]: Reg. 3(2) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 29(b)

[^key-dc6c8f5b26adaf4dc1444525269b184f]: Reg. 3(3) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 29(c)

[^key-872f3996524141906efe941a12699c06]: Reg. 4 substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 30

[^key-6b02eab9937dc75ce5a744360adeb81d]: Words in reg. 8 heading inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 31

[^key-1d4aa01cb0017303f07134a948276c60]: Words in reg. 10 heading inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 32(a)

[^key-7cced74ec7462863ee829d9923d407dd]: Words in reg. 10(4)(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), 32(b)

[^key-2e3816d217bf296050c6d10533f5eed8]: Words in reg. 10(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), 32(c)

[^key-381310b752a32e0a209405ec6611ea32]: Reg. 10(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), 32(d)

[^key-c9d2f9e70f42670544d218008de52d5e]: Reg. 13(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), 35

[^key-bbaa78ceef028eda6a9230e586e2b24a]: Words in reg. 18(1) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 38(a)

[^key-8d3bfeb9ac6f2a57cceea7fa5bd228b8]: Words in reg. 18(2) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 38(b)

[^key-46d8754297ecdf112518355b70fa0292]: Words in reg. 19(2)(a) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 39(a)(i)

[^key-ce1bdb791ae28ab8f526069da4584e26]: Words in reg. 19(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), 39(a)(ii)

[^key-a0f647c53d24261239aead10fe58abfe]: Words in reg. 19(2)(c) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 39(a)(iii)

[^key-228167a828c0fe1c05f2e243654c9c01]: Words in reg. 19(3) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 39(b)

[^key-6de8c109a900729fa1dcc7980f2f8b83]: Words in reg. 19(8)(a) inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 39(c)

[^key-dddb52e7b37b27ab4e8487dbe1a21e17]: Words in reg. 20 substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 40

[^key-6de3e4c4ebc767d66b29e11cb7342330]: Reg. 23(1) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 41

[^key-3b4d45898349d14f552948deee868b18]: Words in reg. 26(1) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 42(a)

[^key-6c598425840d13dc5c0e9cc84a3f4794]: Words in reg. 26(2) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 42(b)

[^key-17e030c9f9e35287cf23783e304950f9]: Sum in reg. 7(5) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 15

[^key-2215ac2ca70fcb7530800216f7ce48dc]: Reg. 16(4A)-(4C) inserted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 16

[^key-eec6fc43dcc1f7b0b81fdf3770b60e0e]: Sum in reg. 17A(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), 17(a)

[^key-7a26d325ec9df9437d2d95f308cee102]: Sum in reg. 17A(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), 17(b)

[^key-f8ace2c8cc0803418601c5043396ccff]: Sum in reg. 19(3) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 18(a)

[^key-c65352293e1fd6072f13950c62fe6590]: Sum in reg. 19(6)(b)(i) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 18(b)(i)

[^key-8041c18d859e5ad3476f1d3a468e8787]: Sum in reg. 19(6)(b)(ii) substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 18(b)(ii)

[^key-5ce2b5fde44ba6e7c557d09120ea4594]: Sum in reg. 19C(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), 19(a)(i)

[^key-dd55fbd21267b6bd40190a74a19ac014]: Sum in reg. 19C(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), 19(a)(ii)

[^key-f168ce71123d89e0983abed77b2656f7]: Sum in reg. 19C(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), 19(b)(i)

[^key-7f75e18bf1ab821dd067d5ee18d7d19d]: Sum in reg. 19C(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), 19(b)(ii)

[^key-d7ad19b1310a8a42fadb40a09b612541]: Sum in reg. 19C(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), 19(c)(i)

[^key-963db8f1683cb7fd03bc53b6d3625261]: Sum in reg. 19C(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), 19(c)(ii)

[^key-c2b183cef27849c5ee42a8091799b6e1]: Reg. 19D 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), 20

[^key-f6efd3f3ebe119ba1483cf7353ae1f6c]: Sum in Sch. 1 Table 1 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 21(2)(a)

[^key-b2d400a5dc71ecb1b4f628dfdaa448a9]: Sum in Sch. 1 Table 1 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 21(2)(b)

[^key-b449abc2684e557b426acd67cb69aae8]: Sum in Sch. 1 Table 1 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 21(2)(c)

[^key-60bce4518ea3dead44cc45de46c62186]: Sum in Sch. 1 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 21(3)(a)

[^key-7250477f8dbbfffeaf6faf570e50f6a1]: Sum in Sch. 1 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 21(3)(b)

[^key-8052097bc4b56b5405954988f12a7739]: Sum in Sch. 1 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 21(3)(c)

[^key-e4c83844b9de8966ffc4c12fe4ca91cc]: Sum in Sch. 2 Table 1 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(2)(a)

[^key-60c1b2b32d10e7f12ba0c0e3188127df]: Sum in Sch. 2 Table 1 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(2)(b)

[^key-d52442a90ed1e63ee079d78cd0f79685]: Sum in Sch. 2 Table 1 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(2)(c)

[^key-1b211e24be73a63b9dedb6b5662ff132]: Sum in Sch. 2 Table 1 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(2)(d)

[^key-a609a2f84e399d9b889c57953e176fa1]: Sum in Sch. 2 Table 1 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(2)(e)

[^key-42da303be086bf8edcd3d6a62d0b0011]: Sum in Sch. 2 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(3)(a)

[^key-fcb850383e3802f3f66b1709d2466185]: Sum in Sch. 2 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(3)(b)

[^key-e518ccbee49e1c1c9f63308a4e1d63ce]: Sum in Sch. 2 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(3)(c)

[^key-28b9cb6b7b59a16e386133070da203a3]: Sum in Sch. 2 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(3)(d)

[^key-a2a6ee7482193904bc94dda0eefeaec4]: Sum in Sch. 2 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(3)(e)(i)

[^key-b527305b21f36dd88248c58a1743e28d]: Sum in Sch. 2 Table 2 substituted (16.7.2025) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2025 (S.I. 2025/749), regs. 1(2), 22(3)(e)(ii)

Advice in relation to intended clinical investigations

17A

• (1) A manufacturer or sponsor may request a meeting with the Secretary of State in advance of an application being submitted under Article 70(1) in order to—

• (a) obtain advice on regulatory requirements relating to an intended clinical investigation; or

• (b) obtain a statistical review in relation to an intended clinical investigation.

• (2) A person who requests a meeting with the Secretary of State under paragraph (1), must pay the following fees in advance of that meeting—

• (a) £987 for a regulatory advice meeting under paragraph (1)(a); and

• (b) £852 for a statistical review meeting under paragraph (1)(b).

• (3) In this regulation, “statistical review” means a review of the statistical sections of the application which a sponsor intends to submit to the Secretary of State under Article 70(1) in respect of an intended clinical investigation.

Part 4A — Fees for consultation in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device

Interpretation of Part 4A

19A

In this Part—

• “approved manufacturer” in relation to a medicinal substance means a manufacturer who—holds a manufacturing authorisation which permits the manufacturer to manufacture that substance for inclusion in an authorised medicinal product; orholds a relevant conformity assessment certificate for a device incorporating that medicinal substance and that certificate was issued by a notified body under Regulation (EU) 2017/745 after consultation with the Secretary of State in respect of that substance;

• “authorised medicinal product” means a medicinal product in respect of which a marketing authorisation has been granted;

• “clinical development” means the conduct of studies of a medicinal substance in human subjects in order to—discover or verify the effects of such a substance,identify any adverse reaction to such a substance, orstudy absorption, distribution, metabolism and excretion of such a substance,with the object of ascertaining the safety or efficacy of that substance, as required to verify the safety and usefulness of the substance in accordance with section 12.1 of Annex I;

• “consultation” means a consultation required by section 5.2 or 5.4 of Annex IX or section 6 of Annex X;

• “further consultation” means a consultation by a notified body in relation to any device which—may be placed on the market or put into service in accordance with Regulation (EU) 2017/745 and which is the subject of a relevant conformity assessment certificate issued by that notified body after consultation with the Secretary of State;is the subject of proposed changes within section 5(f) of Annex IX, and if that device is to be placed on the market or put into service, those changes may require the issue of a supplement to a relevant conformity assessment certificate previously issued by that notified body after consultation with the Secretary of State; oris of a similar design or type to a device which has been the subject of an unsuccessful application for a relevant conformity assessment certificate where—the person who made that unsuccessful application makes a further application for a relevant conformity assessment certificate to the notified body which determined that unsuccessful application; andwithin the relevant period that further application becomes the subject of consultation between that notified body and the Secretary of State;

• “incorporates” means incorporates as an integral part;

• “marketing authorisation” has the meaning given by regulation 8 of the Human Medicines Regulations 2012;

• “medicinal substance” means a substance which, if used separately from a device, may be considered to be a medicinal product, as defined in Schedule 1 (General interpretation provisions) to the Medicines (Products for Human Use) Fees Regulations 2016;

• “new medicinal substance” means a medicinal substance which is not—an authorised medicinal product;an ingredient or, as the case may be, the sole active ingredient of such a product; ora substance which has been incorporated in a device in respect of which a relevant conformity assessment certificate has been issued by a notified body which has consulted the Secretary of State;

• “quality development” means the chemical, pharmaceutical and biological testing required in order to verify the quality of a medicinal substance in accordance with section 12.1 of Annex I;

• “relevant conformity assessment certificate” means either an EU technical documentation assessment certificate issued in accordance with Annex IX or an EU type-examination certificate issued in accordance with Annex X;

• “relevant period” means the period of 5 years which starts on the first day on which the Secretary of State was consulted in respect of the unsuccessful application or, if there has been more than one such application in any particular case, in respect of the first of them;

• “safety development” means the toxicological and pharmacological testing required in order to verify the safety of a medicinal substance in accordance with section 12.1 of Annex I; and

• “scientific advice” means advice in connection with the quality, safety or clinical development for a medicinal substance incorporated, or to be incorporated, in a device.

Circumstances in which a fee is payable in relation to a consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device

19B

• (1) Subject to paragraph (2), the fee payable by a notified body in respect of a consultation or further consultation with the Secretary of State in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device is the fee specified in regulations 19C.

• (2) No fee is payable if it is the first time the Secretary of State has been consulted by any notified body in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device if the medicinal substance is an authorised medicinal product.

Fees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device

19C

• (1) Subject to regulation 19B(2) and paragraph (3), the fee in respect of a consultation in relation to a device which incorporates one or more medicinal substances is—

• (a) £4,953 if each medicinal substance is manufactured by an approved manufacturer of that substance;

• (b) £11,543 if any of the medicinal substances are not manufactured by an approved manufacturer of that substance.

• (2) Subject to paragraph (3), the fee in respect of a further consultation in relation to a device which incorporates one or more medicinal substances is—

• (a) £980 if each medicinal substance is manufactured by an approved manufacturer of that substance;

• (b) £2,668 if any of the medicinal substances are not manufactured by an approved manufacturer of that substance.

• (3) In relation to a device which incorporates a new medicinal substance, the fee is—

• (a) £50,644 for a consultation; and

• (b) £12,574 for a further consultation.

• (4) Where a notified body consults the Secretary of State in relation to more than one device at the same time and those devices—

• (a) are of similar construction and are designed to perform similar functions;

• (b) incorporate medicinal substances of the same specification which are manufactured by the same manufacturer or manufacturers; and

• (c) do not incorporate any other medicinal substance;

the fee payable for that consultation is the fee which would be payable under this regulation for a consultation in relation to one of those devices.

• (5) Any fee payable under this regulation must be paid to the Secretary of State not later than the day on which the notified body consults the Secretary of State.

Fees for pre-consultation meetings

19D

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Certificates of free sale under Regulation (EU) 2017/745 - fee

UK(NI) indication under Regulation (EU) 2017/745

Part 2A — Making available on the market and putting into service under Regulation (EU) 2017/746

Certificates of free sale under Regulation (EU) 2017/746 – fee

10A

A manufacturer or authorised representative who requests a certificate of free sale from the Secretary of State under Article 55 must pay to the Secretary of State a fee of £75.

Retention of documentation relating to conformity assessments

10B

• (1) The liquidator or trustee in bankruptcy of a manufacturer, or of an authorised representative, must—

• (a) retain for the required period any documentation that consists of, or reasonably could consist of, information to which section 7 of Annex IX applies, and

• (b) comply with any request made by the Secretary of State during the required period to provide the Secretary of State with the retained documentation.

• (2) In this regulation, the required period is 10 years after the last device was placed on the market.

UK(NI) indication under Regulation (EU) 2017/746

10C

• (1) This regulation applies if the CE marking is affixed in accordance with Article 18 on the basis of a certificate issued by a notified body established in the United Kingdom.

• (2) The CE marking must be accompanied by the UK(NI) indication.

• (3) The UK(NI) indication may be less than 5mm high provided that it is the same height as the CE marking that it accompanies.

• (4) The manufacturer must affix the UK(NI) indication—

• (a) visibly, legibly and indelibly, and

• (b) before placing the device on the market.

• (5) A person may only make available on the market a device to which this regulation applies if the manufacturer has affixed the UK(NI) indication in accordance with this regulation.

Legal representatives and contact persons for clinical investigations

A11

• (1) The first subparagraph of Article 62(2) (requirement to have a legal representative established in the Union) does not apply to a clinical investigation conducted in Northern Ireland if all of the following conditions are met—

• (a) the clinical investigation is also being conducted in Great Britain;

• (b) the clinical investigation is not also being conducted in a Member State;

• (c) the sponsor—

• (i) is established in Great Britain, or

• (ii) has a written agreement with a legal representative established in Great Britain who is responsible for ensuring compliance with the sponsor’s obligations pursuant to Regulation (EU) 2017/745;

• (d) the sponsor has a contact person established in Northern Ireland in respect of the clinical investigation.

• (2) A contact person referred to in this regulation must be the addressee for all communications with the sponsor provided for in Regulation (EU) 2017/745 and any communication with that contact person is deemed to be a communication with the sponsor.

• (3) The agreement referred to in paragraph (1)(c)(ii) must provide for—

• (a) the legal representative to be responsible for ensuring compliance with the sponsor’s obligations pursuant to Regulation (EU) 2017/745,

• (b) the legal representative to immediately inform the sponsor of all communications received in its capacity as the sponsor’s legal representative, and

• (c) the sponsor to share with its legal representative all communications and documentation necessary to enable the legal representative to fulfil its obligations under this regulation.

• (4) A legal representative referred to in paragraph (1)(c)(ii) must have a written agreement with the contact person to provide for—

• (a) the contact person to immediately inform the legal representative of all communications received in its capacity as the sponsor’s contact person, and

• (b) the legal representative to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.

• (5) Where the sponsor is established in Great Britain, the sponsor must have a written agreement with the contact person to provide for—

• (a) the contact person to immediately inform the sponsor of all communications received in its capacity as the sponsor’s contact person, and

• (b) the sponsor to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.

• (6) Where the sponsor has a legal representative established in Great Britain, the application form and the clinical investigation plan drawn up in accordance with chapter II of Annex XV must include the name, address and contact details of the legal representative established in Great Britain.

Ethical review of clinical investigations

Prior authorisation of clinical investigations by the Secretary of State

Arbitration following the refusal of a clinical investigation application

Damage compensation in relation to clinical investigations

Retention of documentation relating to clinical investigations

Clinical investigation fees

Clinical investigations not carried out for a purpose specified in Article 62(1)

Advice in relation to intended clinical investigations

Part 3A — Performance studies under Regulation (EU) 2017/746

Legal representatives and contact persons for performance studies

17B

• (1) The first subparagraph of Article 58(4) (requirement to have a legal representative established in the Union) does not apply to a performance study conducted in Northern Ireland if all of the following conditions are met—

• (a) the performance study is also being conducted in Great Britain;

• (b) the performance study is not also being conducted in a Member State;

• (c) the sponsor—

• (i) is established in Great Britain, or

• (ii) has a written agreement with a legal representative established in Great Britain who is responsible for ensuring compliance with the sponsor’s obligations under Regulation (EU) 2017/746;

• (d) the sponsor has a contact person established in Northern Ireland in respect of the performance study.

• (2) A contact person referred to in this regulation must be the addressee for all communications with the sponsor provided for in Regulation (EU) 2017/746 and any communication with that contact person is deemed to be a communication with the sponsor.

• (3) The agreement referred to in paragraph (1)(c)(ii) must provide for—

• (a) the legal representative to be responsible for ensuring compliance with the sponsor’s obligations under Regulation (EU) 2017/746,

• (b) the legal representative to immediately inform the sponsor of all communications received in its capacity as the sponsor’s legal representative, and

• (c) the sponsor to share with its legal representative all communications and documentation necessary to enable the legal representative to fulfil its obligations under this regulation.

• (4) A legal representative referred to in paragraph (1)(c)(ii) must have a written agreement with the contact person to provide for—

• (a) the contact person to immediately inform the legal representative of all communications received in its capacity as the sponsor’s contact person, and

• (b) the legal representative to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.

• (5) Where the sponsor is established in Great Britain, the sponsor must have a written agreement with the contact person to provide for—

• (a) the contact person to immediately inform the sponsor of all communications received in its capacity as the sponsor’s contact person, and

• (b) the sponsor to share with the contact person all communications and documentation necessary to enable the contact person to fulfil its obligations under this regulation.

• (6) Where the sponsor has a legal representative established in Great Britain, the application form drawn up in accordance with Chapter I of Annex XIV and any clinical performance study plan drawn up in accordance with Part A of Annex XIII must include the name, address and contact details of the legal representative established in Great Britain.

Ethical review of performance studies

17C

• (1) In Regulation (EU) 2017/746 a reference to an ethics committee is a reference to an ethics committee within the meaning of regulation 3(1).

• (2) In relation to a performance study to which Article 58(5)(b) applies, the sponsor must submit to the Secretary of State a copy of the opinion of the ethics committee as soon as it becomes available and before the performance study starts.

Arbitration following the refusal of a performance study application

17D

• (1) A sponsor notified of a refusal under Articles 66(3), 67(4) or 74(10) may, within 28 days of being notified, apply to the Institute to appoint an adjudicator to review the refusal.

• (2) The adjudicator must provide a report to the Secretary of State and the sponsor, setting out any recommendations in respect of the disputed refusal.

• (3) The Secretary of State must take the report of the adjudicator into account and decide whether to—

• (a) confirm or alter the grounds for the refusal of the application,

• (b) authorise the performance study, or

• (c) in the case of a refusal under Article 66(3), proceed to consider the application under Article 66.

• (4) The Secretary of State must notify the sponsor of the decision in paragraph (3).

• (5) The sponsor must pay any fees, costs and expenses of the Institute and its appointed adjudicator that are payable in connection with the application made under paragraph (1).

Damage compensation in relation to performance studies

17E

A sponsor of a performance study must hold sufficient insurance (or equivalent financial resources) to meet any potential financial liability in the event of injury or death attributable to participation in the performance study.

Retention of documentation relating to performance studies

17F

• (1) The liquidator or trustee in bankruptcy of a sponsor of a performance study, or of a sponsor’s legal representative or contact person under Article 58(4), must—

• (a) retain for the required period any documentation that consists of, or reasonably could consist of, any of the documentation referred to in Annex XIV, and

• (b) comply with any request made by the Secretary of State during the required period to provide the Secretary of State with the retained documentation.

• (2) In this regulation, the required period is—

• (a) in the case of documentation relating to the performance study of a device that was subsequently placed on the market, 10 years after the last device was placed on the market;

• (b) in any other case, 10 years after the performance study ended.

Article	Title of the article
5(1) to (3), (5)	Placing on the market and putting into service
6(1) to (3)	Distance sales
7	Claims
9(3)	Common specifications
10 (except the second, third or fourth sub-paragraphs of paragraph 13)	General obligations of manufacturers
11(1), (3), (6)	Authorised representative
12	Change of authorised representative
13	General obligations of importers
14	General obligations of distributors
15	Person responsible for regulatory compliance
16(3), (4)	Cases in which obligations of manufacturers apply to importers, distributors or other persons
20(1)	Parts and components
22	Identification within the supply chain
29(1) (except the second sentence of the third sub-paragraph), (2)	Summary of safety and performance
48(1), (2), (3) (except the third sub-paragraph), (4) (except the second sub-paragraph), (7) (except the third sub-paragraph), (8) (except the second sub-paragraph), (9) and (10)	Conformity assessment procedures
49(3)	Involvement of notified bodies in conformity assessment procedures
53(1)	Voluntary change of notified body
57	General requirements regarding performance studies
58(1), (2), (4) (except the second sub-paragraph), (5), (6) and (8)	Additional requirements for certain performance studies
79	Post-market surveillance plan
80	Post-market surveillance report
81 (except the second and third sentences of paragraph (2))	Periodic safety update report
84(1), (3) (except the first sub-paragraph), (5) and (8)	Analysis of serious incidents and field safety corrective actions
89 (only the final paragraph)	Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance