The Medical Devices Regulations 2002

• (2) A manufacturer of a relevant device or, where applicable, their UK responsible person shall, when following a conformity assessment procedure, take account of the results of any assessment or verification operations which have been carried out in accordance with this Part at an intermediate stage of manufacture of the device.

• (3) A manufacturer or, where applicable, their UK responsible person shall, in respect of any relevant device which the manufacturer has placed on the market or put into service, keep available for inspection by the Secretary of State—

• (a) the declaration of conformity for that device;

• (b) the technical documentation referred to in Annexes III to VIII relating to that device; and

• (c) the decisions, reports and certificates of approved bodies relating to that device,

for a period ending five years after the manufacture of the last product.

• (4) A person who in the course of manufacturing relevant devices or devices for performance evaluation removes, collects, or uses tissues, cells or substances of human origin shall, in the course of removing, collecting or using those tissues, cells or substances act in accordance with the principles laid down in the Convention of the Council of Europe for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine .

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

UK notified bodies and the conformity assessment procedures forin vitro diagnostic medical devices

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• (1) An approved body which is responsible for carrying out a conformity assessment procedure in relation to a relevant device shall, when carrying out the procedure—

• (a) take account of the results of any assessment or verification operations which have been carried out ... at an intermediate stage of manufacture of the device;

• (b) take account of any relevant information relating to the characteristics and performance of that device, ...; and

• (c) lay down, by common accord with the manufacturer or their UK responsible person, the time limits for completion of the assessment and verification operations referred to in Annexes III to VII.

• (2) Where an approved body takes a decision in accordance with Annex III, IV, or V, they shall specify the period of validity of the decision, which, initially, shall be a period of not more than 5 years.

• (3) Where an approved body and a manufacturer or their UK responsible person have agreed that the manufacturer may apply to the body at a specified time for an extension of the period of validity of a decision referred to in paragraph (2), the body may, on application from and with the agreement of the manufacturer or their UK responsible person, extend the period of validity of the decision for further periods of up to 5 years, each such period commencing on the expiry of the previous period.

Devices for performance evaluation

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No person shall supply a device for performance evaluation (if that supply is also a making available of the device) unless the manufacturer or their UK responsible person—

• (a) has drawn up a statement containing the information required by Section 2 of Annex VIII and keeps that statement available for the Secretary of State for a minimum period of five years after the end of the performance evaluation;

• (b) ensures that—

• (i) the device conforms with the documentation mentioned in the said section 2, and

• (ii) the relevant requirements of these Regulations are complied with as respects that device; and

• (c) undertakes to keep available, and keeps available, for the Secretary of State, for a minimum period of five years after the end of the performance evaluation, documentation allowing an understanding of the design, manufacture and performances of the device, including the expected performances, so as to allow assessment of conformity of the device with the requirements of these Regulations.

Registration of manufacturers etc. of in vitro diagnostic medical devices and devices for performance evaluation

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• (1) Paragraph (2) applies—

• (a) in relation to relevant devices that are Annex II devices or devices for self-testing, to—

• (i) a manufacturer with a registered place of business in Northern Ireland who, under their own name, places on the market in Northern Ireland, or makes available for performance evaluation, any relevant device;

• (ii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (iii) a manufacturer’s authorised representative who has a registered place of business in Northern Ireland;

• (iv) a manufacturer with a registered place of business in Great Britain whose authorised representative does not have a registered place of business in Northern Ireland;

• (b) in relation to relevant devices other than Annex II devices or devices for self-testing, to—

• (i) a manufacturer who places a device on the Northern Ireland market, or makes such a device available for performance evaluation, and has a registered place of business in Northern Ireland;

• (ii) an authorised representative with a registered place of business in Northern Ireland.

• (2) For the purpose of enabling the Secretary of State to exercise the Secretary of State’s functions under these Regulations, any person to whom this paragraph applies must—

• (a) inform the Secretary of State of the address of their registered place of business; and

• (b) supply the Secretary of State with—

• (i) a description of each category of device concerned;

• (ii) the relevant information in paragraph (7);

• (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (d) in the case of an authorised representative, supply the Secretary of State with—

• (i) written evidence that they have been designated as an authorised representative;

• (ii) details of the person who has so designated them; and

• (iii) where the person placing the devices concerned on the market, or making them available for performance evaluation, is neither the manufacturer nor the authorised representative, the name and address of the registered place of business of the person placing the devices concerned on the market, or making them available for performance evaluation;

• (e) inform the Secretary of State of any changes to the information referred to in sub-paragraphs (a) to (d) as and when such changes arise.

• (3) The obligation in paragraph 2(2)(e) to inform the Secretary of State of any changes in relation to the information referred to in sub-paragraphs (2)(a) to (d) continues to apply following the passing of any of the dates specified in paragraph (4) that apply in respect of a particular case.

• (4) The obligations in paragraph (2) begin to apply—

• (a) where a device is being placed on the market by a manufacturer with a registered place of business in Northern Ireland or by a person who has designated an authorised representative with a registered place of business in Northern Ireland, on 1st January 2021;

• (b) in circumstances other than those described in sub-paragraph (a)—

• (i) in the case of a relevant device that is a List A device, on 1st May 2021;

• (ii) in the case of a relevant device that is a device for self-testing, on 1st September 2021; and

• (iii) in the case of a relevant device that is a List B device, on 1st September 2021.

• (5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (7) In this regulation “relevant information” means—

• (a) in relation to a new relevant device, a statement indicating that the device is a new relevant device;

• (b) if the device consists wholly or partly of reagents, reagent products or calibration and control materials, appropriate information in terms of common technological characteristics and analytes;

• (c) if the device does not wholly or partly consist of reagents, reagent products or calibration and control materials, the appropriate indications;

• (d) in relation to devices in a list in Annex II and devices for self-testing—

• (i) all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex 1;

• (ii) if requested by the Secretary of State, the labelling and instructions for use for when the device is placed on the market or put into service;

• (e) in relation to devices for performance evaluation which relate either to devices referred to in a list in Annex II or to devices for self-testing, all data allowing for identification of such devices, the analytical and where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I.

• (8) Within two years of the placing of a new relevant device on the market, the Secretary of State may, where the Secretary of State considers it justified, request a report relating to the experience gained with the device subsequent to it being placed on the market.

• (9) In paragraphs (7) and (8) a device is a “new relevant device” if—

• (a) there has been no such device continuously available on the United Kingdom or EEA market during the previous three years for the relevant analyte or other parameter; or

• (b) use of the device has involved analytical technology not continuously used in connection with a given analyte or other parameter on the United Kingdom or EEA market during the previous three years.

PART V — Notified Bodies Approved Bodies, Conformity Assessment Bodies and Marking of Products

Designation etc. of UK notified bodies

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• (1) The Secretary of State may designate for the purposes of these Regulations any corporate or other body as a body which is to carry out any of the tasks of an approved body, and, if he so designates a body (referred to in these Regulations as an “approved body”), he shall designate the tasks which it is to carry out.

• (2) A body may be designated under paragraph (1) as a body which is to carry out tasks of an approved body only if—

• (a) in so far as it is to be designated as a body which is to carry out tasks included in Part III, it is a body in respect of which the criteria for the designation of approved bodies set out in Annex 8 of Directive 90/385 , read with Regulation (EU) No 722/2012, are met;

• (b) in so far as it is to be designated as a body which is to carry out tasks included in Part II, it is a body in respect of which the criteria for the designation of approved bodies set out in Annex XI of Directive 93/42 , read with Regulation (EU) No 722/2012, are met;

• (c) in so far as it is to be designated as a body which is to carry out tasks included in Part IV, it is a body in respect of which the criteria for the designation of approved bodies set out in Annex IX of Directive 98/79 are met; and

• (d) in so far as it needs to be able to fulfil the functions of an importing Party arising out of a mutual recognition agreement, it is able to do so.

• (3) The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

• (4) The Secretary of State may vary the tasks that an approved body may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

• (5) The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

• (a) the body so requests;

• (b) he considers that it is no longer a body in respect of which the applicable criteria for designation set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met; or

• (c) he considers that the body is not capable of fulfilling the functions of an importing Party arising out of a mutual recognition agreement which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

• (6) Before—

• (a) effecting a variation under paragraph (4); or

• (b) restricting or withdrawing a designation under paragraph (5),

otherwise than at the approved body’s request, the Secretary of State shall give to the approved body an opportunity to make representations to him in writing and shall take into account any such representations as are made.

• (7) For the purpose of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met as respects the tasks which the body wants to carry out, or carries out, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of a mutual recognition agreement which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

• (a) any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

• (b) any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

• (8) The Secretary of State may request that an approved body supply to him any or all relevant information and documents, including budgetary documents, necessary—

• (a) to enable him to verify that the body meets the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, both read with Regulation (EU) No 722/2012, or Annex IX of Directive 98/79; or

• (b) for the purposes of deciding whether or not the body is capable of fulfilling the functions of an importing Party arising out of a mutual recognition agreement which it needs to be able to fulfil,

and the body shall supply to him any and all relevant information or documents so requested.

Choice of notified bodies and conformity assessment bodies

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Where a conformity assessment procedure involves the intervention of an approved body, including work which may be carried out by a third country conformity assessment body, the manufacturer of a device or the manufacturer’s UK responsible person may apply to any approved body or third country conformity assessment body to carry out tasks under that procedure which are within the framework of tasks which the body is designated to carry out.

General matters relating to UK notified bodies

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• (1) An approved body to which an application has been made by a manufacturer or the manufacturer’s UK responsible person to perform the functions of an approved body under a conformity assessment procedure set out in these Regulations shall perform those functions, in accordance with the requirements of the procedure, if those functions are within the framework of tasks which the body is designated to carry out.

• (2) Where a manufacturer or the manufacturer’s UK responsible person has supplied information or data to an approved body in the course of a conformity assessment procedure, that body may, where duly justified, require the manufacturer to provide any additional information or data which it considers necessary for the purposes of that procedure.

• (3) The information, data and correspondence that a manufacturer or the manufacturer’s UK responsible person supplies to an approved body in the course of a conformity assessment procedure set out in these Regulations shall, ..., be in English ....

• (4) An approved body shall, as respects a medical device which it has assessed ..., inform all other approved bodies and the Secretary of State of—

• (a) all certificates suspended or withdrawn; and

• (b) on request, all certificates issued or refused,

and shall also make available to them, on request, any or all additional relevant information.

• (5) Where an approved body finds, as respects a medical device which it has assessed ..., that—

• (a) the applicable requirements of these Regulations have not been met or are no longer met; or

• (b) a certificate issued by it should not have been issued,

it may (having regard in particular to the principle of proportionality and the ability of the manufacturer to take appropriate corrective measures) suspend or withdraw the certificate issued in respect of that device or place restrictions on it, and in such cases, or in cases where the approved body is aware of circumstances in which the Secretary of State may need to take action pursuant to regulation 61, the approved body shall inform the Secretary of State thereof.

• (6) The Secretary of State may request that an approved body supply to him any information and documents that the Secretary of State may, having regard to the terms of a mutual recognition agreement, need to supply to a Party to a mutual recognition agreement, and the body shall supply to him any and all information or documents so requested.

• (8) An approved body shall provide conformity assessment bodies with all the information it is required to provide to those bodies under a mutual recognition agreement.

• (9) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (10) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Designation etc. of EC conformity assessment bodies

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• (1) The Secretary of State may designate for the purposes of a mutual recognition agreement any corporate or other body as a body which is to carry out any of the tasks of a ... conformity assessment body, and, if he so designates a body (referred to in these Regulations as a “CAB”), he shall designate the tasks which it is to carry out.

• (2) A body may be designated under paragraph (1) as a body which is to carry out tasks of a CAB only if the Secretary of State considers that the body is capable of fulfilling the functions of a CAB arising out of a mutual recognition agreement which it needs to be able to fulfil.

• (3) The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

• (4) The Secretary of State may vary the tasks that a CAB may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

• (5) The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

• (a) the body so requests; or

• (b) he considers that the body is not capable of fulfilling the functions of a CAB arising out of a mutual recognition agreement which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

• (6) Before—

• (a) effecting a variation under paragraph (4); or

• (b) restricting or withdrawing a designation under paragraph (5),

otherwise than at the ... CAB’s request, the Secretary of State shall give to the ... CAB an opportunity to make representations to him in writing and shall take into account any such representations as are made.

• (7) For the purpose of deciding whether or not a body is capable of fulfilling the functions of a CAB arising out of a mutual recognition agreement which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

• (a) any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

• (b) any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

• (8) The Secretary of State may request that a CAB supply to him any or all relevant information and documents, including budgetary documents, necessary for the purposes of deciding whether or not the body is capable of fulfilling the functions of a CAB arising out of a mutual recognition agreement which it needs to be able to fulfil, and the body shall supply to him any and all relevant information or documents so requested.

Fees charged by UK notified bodies and EC conformity assessment bodies

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• (1) An approved body or CAB may charge a fee in accordance with paragraphs (2), (3) and (4) for anything done in, or in connection with—

• (a) in the case of an approved body, performing the functions of an approved body or an importing Party under these Regulations or a mutual recognition agreement; and

• (b) in the case of a CAB, performing the functions of a CAB arising out of a mutual recognition agreement in respect of a conformity assessment procedure for a medical device.

• (2) Except as provided for by paragraph (3), the fee charged in respect of anything done shall not exceed an amount which reasonably represents the cost incurred, or to be incurred, in doing it.

• (3) Where the approved body or CAB charging the fee is a body the activities of which are carried on for profit, the fee may include an amount representing a profit which is reasonable in the circumstances, having regard to—

• (a) the character and extent of the work done or to be done by the approved body; and

• (b) the commercial rate normally charged in respect of profit for that work or similar work.

• (4) The approved body or CAB may require payment of the fee, or a reasonable estimate of the fee, in advance of carrying out the work in respect of which the fee is payable and as a condition of doing that work.

Products incorrectly marked with a notified body or conformity assessment body number

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• (1) No person shall—

• (a) affix an approved body or conformity assessment body number to a medical device if that body has not carried out an assessment in respect of that device for that person;

• (b) supply a medical device (if that supply is also a placing on the market, or if that supply is of a device which has been placed on the market) which has affixed to it an approved body or conformity assessment body number if that body—

• (i) has not carried out an assessment in respect of that device, or has not carried out that assessment for the person responsible for placing the device on the market, or

• (ii) has had its designation as an approved body or conformity assessment body withdrawn.

• (2) No person shall provide information comprising an approved body or conformity assessment body number on a medical device, the instructions for use for a medical device, or the sales packaging for a medical device if that device—

• (a) is being or has been placed on the market; and

• (b) the approved body or conformity assessment body—

• (i) has not carried out an assessment in respect of that device, or has not carried out that assessment for the person responsible for placing the device on the market, or

• (ii) has had its designation as an approved body or conformity assessment body withdrawn.

• (3) Where the sectoral annex on medical devices in a Mutual Recognition Agreement under which a conformity assessment body was designated states that the annex does not apply to devices of a particular class or description, no person may supply a medical device of that class or description bearing the number of that conformity assessment body (if that supply is also a placing on the market or putting into service or is of a device that has been placed on the market or put into service) unless—

• (a) an assessment has been carried out on that device for the person responsible for placing it on the market or putting it into service by an approved body; and

• (b) the device bears the approved body number of that approved body.

• (4) For the purposes of this regulation, an approved body shall be taken to have carried out an assessment in respect of a device if it has endorsed a report prepared by a third country conformity assessment body in respect of that device.

Products incorrectly marked with a CE marking

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• (1) No person shall—

• (a) affix the UK marking for a medical device to a product which is not a medical device; or

• (b) supply a product (if that supply is also a placing on the market, or if that supply is of a product which has been placed on the market) which has affixed to it the UK marking for a medical device if that product is not a medical device.

• (2) No person shall provide information comprising a UK marking for a medical device on a product, the instructions for use for a product, or the sales packaging for a product if the product is not a medical device.

PART VI — Fees charged by the Secretary of State

Interpretation of Part VI

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• (1) 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 an examination certificate for a device incorporating that medicinal substance and that certificate was issued by an approved body or notified body 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 7.4 of Annex I of Directive 93/42 and section 10 of Annex I of Directive 90/385;

• “consultation” means a consultation required by—section 4.3 of Annex II of Directive 93/42 or Directive 90/385; orsection 5 of Annex III of Directive 93/42 or Directive 90/385;

• “examination certificate” means—a design-examination certificate within the meaning of sections 4.3 and 4.4 of Annex II of Directive 93/42 or Directive 90/385, issued by an approved body;a type-examination certificate within the meaning of sections 5 and 6 of Annex III of Directive 93/42 or Directive 90/385, issued by an approved body;an EC design-examination certificate within the meaning of sections 4.3 and 4.4 of the version of Annex II of Directive 93/42 or Directive 90/385 that existed immediately before IP completion day, issued by a notified body; oran EC type-examination certificate within the meaning of sections 5 and 6 of the version of Annex III of Directive 93/42 or Directive 90/385 that existed immediately before IP completion day), issued by a notified body;

• “further consultation” means a consultation by an approved body in relation to any device which—may be placed on the market or put into service in accordance with Part 2 or 3 and which is the subject of an examination certificate issued by that approved body after consultation with the Secretary of State;is the subject of proposed changes within section 4.4 of Annex II of Directive 93/42 or Directive 90/385 or section 6 of Annex III of Directive 93/42 or Directive 90/385 and if that device is to be placed on the market or put into service, those changes may require a supplement to the examination certificate previously issued by that approved 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 an examination certificate where—the person who made that unsuccessful application makes a further application for an examination certificate to the approved body which determined that unsuccessful application; andwithin the relevant period that further application becomes the subject of consultation between that approved body and the Secretary of State;

• “Group A device” means a Class I medical device, a Class IIa medical device, or a Class IIb medical device which is neither an implantable device nor a long term invasive medical device;

• “Group B device” means a Class IIb medical device which is either an implantable medical device or a long term invasive medical device, or a Class III medical device, or an active implantable medical device; and “half day” means a period of three and a half hours.

• “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 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 an examination certificate has been issued by an approved 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 paragraph 7.4 of Annex I of Directive 93/42 and section 10 of Annex I of Directive 90/385;

• “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 paragraph 7.4 of Annex I of Directive 93/42 and section 10 of Annex I of Directive 90/385; 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.

• (2) For the purposes of this Part, medical devices are classified as being implantable or long term invasive medical devices in accordance with the definitions set out in Section 1 of Annex IX of Directive 93/42, and in the event of a dispute over the classification of a device, the Secretary of State shall determine the classification of the device in accordance with the definitions set out in Section 1 of Annex IX of Directive 93/42.

Fees in connection with the registration of devices and changes to registration details

53

• (1) Any person required to supply the Secretary of State with any information under regulation 7A, 19, 21A, 33A or 44 shall, in respect of the processing of that information with regard to the possible registration of that person by the Secretary of State or possible changes to his registration details, pay to the Secretary of State a fee of £300, and that fee—

• (a) shall be payable when the information is supplied by that person to the Secretary of State; and

• (b) shall accompany that information when it is supplied.

• (2) Any person who has a registration in accordance with regulation 7A, 19, 21A, 33A or 44 shall, in respect of the maintenance of that registration by the Secretary of State, pay to the Secretary of State an annual fee of £300 for each device registered and that fee—

• (a) shall be payable for each fee period during which the registration is maintained, starting with the fee period immediately following that in which the person paid the fee for the device registration in accordance with paragraph (1); and

• (b) shall be due on the first day of each fee period in relation to which a fee is payable.

• (3) Where a person is liable to pay a fee under this regulation in respect of a device, no fee is payable under this regulation for an additional device which has the same registration category (whether registered simultaneously or subsequently, and whether the additional device also has other registration categories or not).

• (4) Where a person supplies information referred to in paragraph (1) after the first day of a fee period, then the amount of the fee due in accordance with paragraph (1) shall be adjusted, pro rata, starting with the day on which the information is supplied, in accordance with the remaining number of days in the fee period.

• (5) A person may not place a device on the market unless they have paid all fees for which they are liable under this regulation, whether or not those fees relate to that device.

• (6) Where a person has registered a device under this regulation prior to 1st April 2026, the first fee period for which a fee is payable under paragraph (2) begins on 1st April 2026 and ends on 31st March 2027.

• (7) In this regulation—

• “fee period” means the period beginning with 1st April in any year and ending with 31st March in the following year;

• “Global Medical Device Nomenclature” means the standard for the naming and categorisation of medical devices as maintained by the GMDN Agency, a company with registered company number 05392271, or any successor to that company;

• “maintenance”, in relation to a registration, includes—holding information supplied in relation to a registration;regulatory oversight by the Secretary of State;monitoring, identification, and addressing of safety issues by the Secretary of State in relation to the device registered.

• “registration category” means, in accordance with the Global Medical Device Nomenclature as at the first day of the relevant fee period—a Level 2 Category; orwhere there is no applicable category under sub-paragraph (a), a Level 1 Category.

Fees payable in connection with the designation of approved bodies

54

• (1) A corporate or other body that applies to the Secretary of State for designation under regulation 45 as an approved body shall, in connection with that application for designation, pay to the Secretary of State—

• (a) if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of £10,335; or

• (b) in all other cases, a fee of £41,337.

• (2) A corporate or other body that applies to the Secretary of State for a variation under regulation 45(4) must, in connection with that application for a variation, pay to the Secretary of State—

• (a) in respect of an extension to the scope of the body’s designation to carry out tasks under Part 2, Part 3 or Part 4, which extends the body’s designation in relation to a Part under which they have already been designated, a fee of £14,568;

• (b) in respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out certain tasks that were not previously within the scope of the body’s designation and where the Secretary of State considers that an additional assessment of the body’s procedures is required, a fee of £21,105.

• (3) Where, pursuant to regulation 45(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is one in respect of which the criteria set out in Annex 8 of Directive 90/385, Annex XI of Directive 93/42, both read with Regulation (EU) No 722/2012 or Annex IX of Directive 98/79 are met, or for the purposes of deciding whether or not a body is capable of fulfilling the functions of an importing Party arising out of a mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State—

• (a) in respect of an initial inspection pursuant to regulation 45(7)(a), a fee of £67,606 plus the amounts specified in paragraph (3A);

• (b) in respect of an inspection pursuant to regulation 45(7)(a), other than an initial inspection, a fee of £52,929, plus the amounts specified in paragraph (3A); and

• (c) in respect of an inspection pursuant to regulation 45(7)(b), a fee of £11,672 plus the amounts specified in paragraph (3A).

• (3A) Subject to paragraph (3B), the additional amounts payable in respect of an inspection referred to in paragraph (3) shall be—

• (a) an amount for time spent by a member of staff undertaking a site visit at a rate—

• (i) for the time spent on site, of £732 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and

• (ii) for the time spent travelling to and from the site, of £198 per hour;

• (b) the actual costs of travel, accommodation and subsistence; and

• (c) out of pocket expenses.

• (3B) Where the Secretary of State conducts an inspection referred to in paragraph (3)(a) on the same date and at the same premises as an inspection pursuant to regulation 48(7)(a)—

• (a) the amount referred to in paragraph (3A)(3) shall include an amount for any time spent on site by a member of staff which is attributable to the conduct of the inspection pursuant to regulation 48(7)(a), at the rate referred to paragraph (3A)(a)(i); and

• (b) the costs and expenses referred to in paragraph (3A)(b) and (c) shall include any additional costs and expenses attributable to the conduct of the inspection pursuant to regulation 48(7)(a).

• (3C) An approved body that applies to the Secretary of State for a renewal of its designation pursuant to article 4 of Regulation (EU) No 920/2013 shall pay to the Secretary of State—

• (a) a fee of £41,337 in respect of the application; and

• (b) where an audit is carried out in connection with the application, a fee of £67,606 in respect of the audit ,

plus the amounts specified in paragraph (3A).

• (3D) Where the Secretary of State conducts an assessment of an approved body pursuant to article 5 of Regulation (EU) No 920/2013, the approved body shall pay to the Secretary of State—

• (a) if the assessment relates to the UK notified body’s assessment of clinical data only, a fee of £21,535; or

• (b) in any other case, a fee of £26,408 ,

plus the amounts specified in paragraph (3A).

• (3E) An approved body that submits a summary evaluation report to the Secretary of State pursuant to article 5(4) of Regulation (EU) No 722/2012 shall pay to the Secretary of State a fee of £1,503.

• (3F) Where, pursuant to regulation 45(7)(a) or 45(7)(b), the Secretary of State conducts an on-site assessment of a subsidiary of the body, the body must pay to the Secretary of State a fee of £26,408, plus the costs and expenses referred to in paragraph (3A).

• (4) A fee under this regulation—

• (a) in connection with an application for designation under regulation 45(1), a variation under regulation 45(4) , a renewal under Regulation (EU) No 920/2013 (but not any associated audit) or a submission of a summary evaluation report under Regulation (EU) No 722/2012—

• (i) shall be payable when the application or submission to the Secretary of State is made, and

• (ii) shall accompany the application or submission when it is made;

• (b) in connection with an inspection pursuant to regulation 45(7) or an audit or assessment pursuant to Regulation (EU) No 920/2013, shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.

• (5) In this regulation—

• “Regulation (EU) No 920/2013” means Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices; and

• “subsidiary” is to be construed in accordance with section 1159 of the Companies Act 2006.

Fees payable in connection with the designation etc. of ... conformity assessment bodies

55

• (1) A corporate or other body that applies to the Secretary of State for designation under regulation 48 as a CAB shall, in connection with that application for designation, pay to the Secretary of State—

• (a) if it is the second or subsequent such application and the application is being made only to address the grounds for rejection of a previous application, a fee of £10,335; or

• (b) in all other cases, a fee of £41,337.

• (2) A corporate or other body that applies to the Secretary of State for a variation under regulation 48(4) must, in connection with that application for a variation, pay to the Secretary of State—

• (a) in respect of an extension to the scope of the body’s designation to carry out tasks arising out of a mutual recognition agreement that were not previously within the scope of the body’s designation, a fee of £14,568; or

• (b) in respect of an extension to the scope of the body’s designation, which extends the body’s designation to carry out certain tasks that were not previously within the scope of the body’s designation and which requires the Secretary of State to undertake an additional assessment of the body’s procedures, a fee of £21,105.

• (3) Subject to paragraphs (3A) to (3C) where, pursuant to regulation 48(7) the Secretary of State inspects premises for the purposes of deciding whether or not a body is capable of fulfilling the functions of a CAB arising out of a mutual recognition agreement which it needs to be able to fulfil, the body shall pay to the Secretary of State—

• (a) in respect of an initial inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), fee of £67,606 plus the amounts specified in paragraph (3D);

• (b) in respect of any other inspection pursuant to regulation 48(7)(a), other than an inspection referred to in sub-paragraph (c), a fee of £11,672 plus the amounts specified in paragraph (3D);

• (c) in respect of an inspection pursuant to regulation 48(7)(a) conducted on the same date and at the same premises as an inspection pursuant to regulation 45(7), a fee of £1,880;

• (d) in respect of an inspection pursuant to regulation 48(7)(b), a fee of £11,672 plus the amounts specified in paragraph (3D).

• (3A) Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and one of the inspections is an initial inspection, the fee payable shall be £67,606 plus—

• (a) £1,880 for each additional inspection; and

• (b) the amounts specified in paragraph (3D).

• (3B) Where the Secretary of State conducts two or more inspections pursuant to regulation 48(7)(a) on the same date and at the same premises, other than inspections referred to in paragraph (3)(c), and none of the inspections is an initial inspection, the fee payable shall be £11,672 plus—

• (a) £1,880 for each additional inspection; and

• (b) the amounts specified in paragraph (3D)

• (3C) Where the Secretary of State conducts two or more inspections referred to in paragraph (3)(c) on the same date and at the same premises, the fee payable for the inspections pursuant to regulation 48(7)(a) shall be £1,880 for each inspection.

• (3D) The additional amounts payable in respect of an inspection referred to in paragraphs (3) to (3B) shall be—

• (a) an amount for time spent by a member of staff undertaking a site visit at a rate—

• (i) for the time spent on site, of £732 per half day (periods of less than a half day counting as a half day) up to a maximum of two half days on any one date, and

• (ii) for the time spent travelling to and from the site, of £198 per hour;

• (b) the actual costs of travel, accommodation and subsistence, and

• (c) out of pocket expenses.

• (4) A fee under this regulation—

• (a) in connection with an application for designation under regulation 48(1) or a variation under regulation 48(4)—

• (i) shall be payable when the application to the Secretary of State is made, and

• (ii) shall accompany the application when it is made;

• (b) in connection with an inspection pursuant to regulation 48(7), shall be payable within one month of receipt by the body of a written notice from the Secretary of State requiring payment of the fee.

Fees payable in relation to clinical investigation notices

56

• (1) Subject to paragraph (2), any person required to give the Secretary of State notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall, in respect of the consideration by the Secretary of State of the information that the person is required to submit, pay to the Secretary of State—

• (a) if, as regards that device, it is the second or subsequent occasion on which the person has given the Secretary of State notice of an intended clinical investigation, and the changes from the immediately preceding notice are limited to addressing the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation—

• (i) a fee, if the device is a Group A device, of £11,701, or

• (ii) a fee, if the device is a Group B device, of £22,678; or

• (b) in all other cases—

• (i) a fee, if the device is a Group A device, of £15,309, or

• (ii) a fee, if the device is a Group B device, of £32,016.

• (2) Except where paragraph (3) or (3A) applies, no fee shall be payable in respect of a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) where the manufacturer or their UK responsible person has previously given such notice in relation to that device.

• (3) A fee shall be payable where the investigational plan which forms part of the statement accompanying the notice differs from the plan submitted with the immediately preceding notice in that it includes—

• (a) a change to address the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation;

• (b) a change to the number of patients or devices forming the basis of the proposed trial;

• (c) a change or extension in the indications for use of the device or to the purpose or objectives of the trial;

• (d) a change in any of the materials used in the device that come into direct contact with the human body if the new materials are not known to be biocompatible; or

• (e) a change in the design of the device involving a novel feature not previously tested, being a change that has a direct effect on a vital physiological function.

• (3A) Any person who submits an amendment to a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall pay to the Secretary of State—

• (a) a fee, if the device is a Group A device, of £226; or

• (b) a fee, if the device is a Group B device, of £361.

• (3B) A person who requests a meeting with the Secretary of State in respect of an intended clinical investigation under regulation 16(1A) or 29(1A) must pay the following fees in advance of the meeting—

• (a) £987 for a regulatory advice meeting under regulation 16(1A)(a) or 29(1A)(a); and

• (b) £852 for a statistical review meeting under regulation 16(1A)(b) or 29(1A)(b).

• (4) A fee under this regulation—

• (a) shall be payable when the notice to which it relates is given to the Secretary of State; and

• (b) shall accompany that notice when it is given.

Unpaid fees

57

All unpaid sums due by way of, or on account of, any fees payable under this Part are recoverable as debts due to the Crown.

Waivers, reductions and refunds

58

• (1) The Secretary of State may—

• (a) waive payment of any fee or reduce any fee or part of a fee otherwise payable under this Part;

• (b) refund the whole or part of any fee paid pursuant to this Part.

• (2) Without prejudice to the generality of paragraph (1), where—

• (a) a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) is withdrawn within the period of 7 days beginning with the date of its receipt by the Secretary of State; or

• (b) an application for designation as—

• (i) an approved body under regulation 45(1), or

• (ii) a CAB under regulation 48(1),

(other than one submitted only to address the grounds of rejection of a previous application) is withdrawn within the period of 21 days beginning with the date of its receipt by the Secretary of State,

PART VII — General, Enforcement and Miscellaneous

Interpretation of Part VII

59

In this Part ...—

• “registrable device” means a device in respect of which, in accordance with the Medical Devices Directives, registration is required with the competent authorities of a Member State or (where appropriate) a State which is a Party to an Association Agreement;

• “relevant device” means a device that is a “relevant device” for the purposes of Part II, III or IV ....

Designation etc. of authorised representatives

60

• (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (3) A UK responsible person—

• (a) may be proceeded against as a person placing the device on the market for the purposes of these regulations;

• (b) in relation to the supply of the device to a person within the United Kingdom after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market.

• (4) If a person claims or purports to act as a UK responsible person, the Secretary of State may, for the purposes of enabling the Secretary of State to exercise his functions under these Regulations, require that person to furnish the Secretary of State with sufficient evidence that he is a UK responsible person.

Enforcement etc.

61

• (1A) It is the duty of the Secretary of State to enforce these regulations in relation to relevant devices and devices for performance evaluation.

• (1B) It is the duty of each weights and measures authority in Great Britain and each district council in Northern Ireland to enforce these regulations within its area (concurrently with the Secretary of State) in relation to relevant devices that are ordinarily intended for private use or consumption.

• (1C) Nothing in this regulation authorises a weights and measures authority to bring proceedings in Scotland for an offence.

Compliance notices

62

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

Restriction notices

63

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

Notification of decisions etc.

64

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

Centralised systems of records etc.

65

The Secretary of State shall perform, as respects Northern Ireland, the functions of the Member State under article 8 of Directive 90/385, article 10 of Directive 93/42 and article 11(1) to (3) of Directive 98/79.

Revocations

66

The following provisions are hereby revoked—

• (a) the Active Implantable Medical Devices Regulations 1992 ;

• (b) the Medical Devices Regulations 1994 ;

• (c) the Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995 ;

• (d) the Medical Devices Fees Regulations 1995 ;

• (e) the Medical Devices Fees (Amendment) Regulations 1997 ;

• (f) theIn Vitro Diagnostic Medical Devices Regulations 2000 ; and

• (g) regulations 6 and 13 of the Medicines (Codification Amendments Etc.) Regulations 2002 .

SCHEDULE 1 — ASSOCIATION AGREEMENTS

1

The Agreement establishing an Association between the European Economic Community and Turkey signed at Ankara on 12th September 1963.

SCHEDULE 2 — MUTUAL RECOGNITION AGREEMENTS

1

The agreement on mutual recognition in relation to conformity assessment certificates and markings between the European Community and Australia, initialled on 19th July 1996 .

2

The agreement on mutual recognition in relation to conformity assessment between the European Union and New Zealand, initialled on 19th July 1996 .

3

The agreement on mutual recognition between the European Community and Canada, signed in London on 14th May 1998 .

4

The agreement on mutual recognition between the European Community and the United States of America, signed in London on 18th May 1998 .

Signed

Signed by authority of the Secretary of State for Health

Hunt — Parliamentary Under Secretary of State, — Department of Health — 2002-05-19

We consent,

Tony McNulty — Nick Ainger — Two of the Lords Commissioners of Her Majesty’s Treasury — 2002-05-20

Explanatory note

(This note is not part of the Regulations)

Footnotes

[^f00001]: 1972 c. 68.

[^f00002]: The Secretary of State was designated in relation to measures relating to active implantable medical devices in S.I. 1991/2289, and in relation to measures relating to medical devices other than active implantable medical devices in S.I. 1993/2661.

[^f00003]: 1973 c. 51.

[^f00004]: 1987 c. 43.

[^f00005]: OJ No. L. 189, 20.7.1990, p.17.

[^f00006]: Council Directive 90/385/EEC has been amended by Council Directive 93/42/EEC (OJ No. L. 169, 12.7.1993, p.1) and Council Directive 93/68/EEC (OJ No. L 220, 30.8.1993, p.1).

[^f00007]: OJ No. L 169, 12.7.1993, p.1.

[^f00008]: Council Directive 93/42/EEC has been amended by Directive 98/79/EC (OJ No. L 331, 7.12.1998, p.1), Directive 2000/70/EC (OJ No. L 313, 13.12.2000, p.22) and Directive 2001/104/EC (OJ No. L 6, 10.1.2002, p.50).

[^f00009]: OJ No. L 331, 7.12.1998, p.1.

[^f00010]: OJ No. L 311, 28.11.2001, p.67.

[^f00011]: OJ No. L 1, 3.1.1994, p.3.

[^f00012]: OJ No. L 1, 3.1.1994, p.572.

[^f00013]: OJ No. L 204, 21.7.1998, p.37; amended by Directive 98/48/EC (OJ No. L 217, 5.8.1998, p.18).

[^f00014]: OJ No. L 262, 27.9.1976, p.169.

[^f00015]: Council Directive 76/768/EEC was amended for the twenty-sixth time by Commission Directive 2000/41/EC (OJ No. L 145, 20.6.2000, p.25).

[^f00016]: OJ No. L 399, 30.12.1989, p.18.

[^f00017]: Council Directive 89/686/EEC has been amended by Council Directive 93/68/EEC (OJ No. L 220, 30.8.1993, p.1), Council Directive 93/95/EEC (OJ No. L 276, 9.11.1993, p.11) and Council Directive 96/58/EC (OJ No. L 236, 18.9.1996, p.44).

[^f00018]: S.I. 1993/2360.

[^f00019]: Council of Europe (ETS No. 164), Orviedo, 4.4.1997.

[^f00020]: See section s 11(1) and 45(1) of that Act.

[^f00021]: See section 45(1) of that Act.

[^f00022]: See section 11(7) of that Act.

[^f00023]: S.I. 1992/3146.

[^f00024]: S.I. 1994/3017.

[^f00025]: S.I. 1995/1671.

[^f00026]: S.I. 1995/2487.

[^f00027]: S.I. 1997/694.

[^f00028]: S.I. 2000/1315.

[^f00029]: S.I. 2002/236.

[^f00030]: OJ No. L 135, 17.5.2001, p.35.

[^f00031]: OJ No. L 229, 17.8.1998, p.3.

[^f00032]: OJ No. L 229, 17.8.1998, p.62.

[^f00033]: OJ No. L 280, 16.10.1998, p.3.

[^f00034]: OJ No. L 31, 4.2.1999, p.3.

Essential requirements forin vitro diagnostic medical devices

Determining compliance ofin vitro diagnostic medical devices with relevant essential requirements

CE marking ofin vitro diagnostic medical devices

CE marking ofin vitro diagnostic medical devices that come within the scope of more than one Directive

Procedures for affixing a CE marking toin vitro diagnostic medical devices

Registration of manufacturers etc. ofin vitro diagnostic medical devices and devices for performance evaluation

Editorial notes

[^c17036851]: 1972 c. 68.

[^c17036861]: The Secretary of State was designated in relation to measures relating to active implantable medical devices in S.I. 1991/2289, and in relation to measures relating to medical devices other than active implantable medical devices in S.I. 1993/2661.

[^c17036871]: 1973 c. 51.

[^c17036881]: 1987 c. 43.

[^c17037021]: S.I. 1993/2360.

[^c17037031]: Council of Europe (ETS No. 164), Orviedo, 4.4.1997.

[^c17037071]: S.I. 1992/3146.

[^c17037081]: S.I. 1994/3017.

[^c17037091]: S.I. 1995/1671.

[^c17037101]: S.I. 1995/2487.

[^c17037111]: S.I. 1997/694.

[^c17037121]: S.I. 2000/1315.

[^c17037131]: S.I. 2002/236.

[^c17037151]: OJ No. L 229, 17.8.1998, p.3.

[^c17037161]: OJ No. L 229, 17.8.1998, p.62.

[^c17037171]: OJ No. L 280, 16.10.1998, p.3.

[^c17037181]: OJ No. L 31, 4.2.1999, p.3.

[^key-00a51bd0b3f598af12c337ac8384dec7]: Reg. 62 omitted (26.5.2021) by virtue of Medicines and Medical Devices Act 2021 (c. 3), ss. 41(7)(a), 50(3) (with s. 41(8)); S.I. 2021/610, reg. 2(c) (with reg. 3)

[^key-00bbcf53d3052aacd0704256a5e84cce]: Words in reg. 48(5) 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(e)(i)

[^key-0116a30f0a6f27d07898ddda71d73820]: 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

[^key-0158f8b5ec760bfb1edc2f5c1b03135b]: Reg. 10A(3A) inserted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 33

[^key-03074a47b0f43b3ddae8d5ed03799b2c]: 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)(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-03f68e089618330913a29dd6ff1f1edc]: Reg. 26(4)(5) 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(5)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 28); 2020 c. 1, Sch. 5 para. 1(1)

[^key-0407ce1636bb613ba447d309f6d69473]: 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)

[^key-041a14ab6e53291bdfb43be82132a084]: Words 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)(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-0445a735812c2f91dca8046165d673d4]: Words in reg. 47(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(6)(e)(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-0473d4cdc19a968421872507ce3c9f8d]: Words in reg. 2(1) 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. 1(b)

[^key-0478e6ef46caa15c0d3562fd99e1e8de]: Words in reg. 30A(3)(f) substituted (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 8(3)(b)

[^key-04f01c34aaec7fa7e71c485315f51768]: Words in reg. 3(e)(ii) omitted (21.3.2010) by virtue of The Medical Devices (Amendment) Regulations 2008 (S.I. 2008/2936), regs. 1(1), 3(c)

[^key-05ddd4baea7f0cd03c1f6e795d2963ef]: Words in reg. 54(3C) 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(6)(c)

[^key-067027de86c467c757751d0976c434a8]: 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)

[^key-0977a9d8e03eeedcb34d5d7d3bfc26c2]: Reg. 65 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(7) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-09e637b6cd126f45d96e4dcbe3c3302e]: Reg. 21B(5) omitted (27.7.2021) by virtue of The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 35(d)

[^key-0bbbd4022d6ec30e9ce08b1f17599f98]: 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)(t) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-0bc9051bdbd73baa8375562ac038a85b]: Words in reg. 31(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), 5(7)(d)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 33); 2020 c. 1, Sch. 5 para. 1(1)

[^key-0bd9a2f598c5779ee5d255f6010c4bd8]: Words in reg. 36 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(4A)(a) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 38); 2020 c. 1, Sch. 5 para. 1(1)

[^key-0be9120d33c5eb03ec6568875c613016]: 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)

[^key-0cc5843f823477eeecb527a75edf8173]: Words in reg. 44ZA(1)(a) substituted (E.W.S.) (1.7.2023) by The Medical Devices (Amendment) (Great Britain) Regulations 2023 (S.I. 2023/627), regs. 2(2), 9(2)

[^key-0cd46d6b34bd107f92011fa959166f4b]: Words in reg. 2(1) inserted (N.I.) (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 30(b)

[^key-0e5dd4b34487e9254ab20b397d51d96c]: 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)(iii) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)

[^key-0e755ed2daac977bda2d3ce3895eded1]: Words in reg. 31(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), 5(7)(c) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 33); 2020 c. 1, Sch. 5 para. 1(1)

[^key-0f193cde2586bd509e8b54d99193c35b]: Reg. 4(6) added (1.4.2004) by The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(b), 3(b)

[^key-0fe6d0bc08b4cfcdd8fc2bdc871aed69]: Sch. 2A para. 3(h) 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)(iv)

[^key-10bf6fc9f6e76a5638f93d1bba14c747]: Regs. 38A-38C inserted (28.7.2021) by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (S.I. 2021/910), regs. 1(1), 6

[^key-10d2c2d69fdc646f29350b5c183c4a1d]: Words in reg. 50(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(10)(d) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)

[^key-1102197b48a9ab9d158d2808dab770be]: Words in reg. 49(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(9)(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-1120cb0b9f5eed045883c520ccb74cc2]: Words in reg. 2(1) substituted (1.7.2012) by The Medical Devices (Amendment) Regulations 2012 (S.I. 2012/1426), regs. 1(1), 2(a)(iii)

[^key-11583605e8ca5cb788605c649f373aac]: 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)(i) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 20); 2020 c. 1, Sch. 5 para. 1(1)

[^key-11d2bb62e9f3dd9972e5c0fc74b1521e]: Words in reg. 45(7) 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)(k) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)

[^key-128f7f52d5cef387279c8924dadf25ac]: Reg. 9(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), 4(6)(a)(ii) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 2); 2020 c. 1, Sch. 5 para. 1(1)

[^key-12e92185d1e570fb5117fc341329d8a6]: Words in reg. 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. 2(a)

[^key-13d9a0f726fccdeb1a660f3f75f97215]: Words in reg. 45(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(4)(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-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)