The Medical Devices (Northern Ireland Protocol) Regulations 2021

[F1 Interpretation of Part 4A U.K.

19A.   In this Part—

“approved manufacturer” in relation to a medicinal substance means a manufacturer who—

(a)

holds a manufacturing authorisation which permits the manufacturer to manufacture that substance for inclusion in an authorised medicinal product; or

(b)

holds 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—

(a)

discover or verify the effects of such a substance,

(b)

identify any adverse reaction to such a substance, or

(c)

study 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—

(a)

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;

(b)

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; or

(c)

is 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—

(i)

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; and

(ii)

within 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—

(a)

an authorised medicinal product;

(b)

an ingredient or, as the case may be, the sole active ingredient of such a product; or

(c)

a 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.]

Textual Amendments

F1 Pt. 4A inserted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 23