OpenLegislation

The Medical Devices (Northern Ireland Protocol) Regulations 2021 in Scotland

S.I. 2021/905 · Made 26 July 2021 · Extends to United Kingdom

Up to date with all changes known to legislation.gov.uk, revised to 1 April 2026.

Medical Devices

Consumer Protection

Made 26th July 2021

Coming into force 27th July 2021

The Secretary of State, in exercise of the powers conferred by section 8C of, and paragraph 1(1)(ab) of Schedule 4, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018f1, makes the following Regulations.

A draft of this instrument has been approved by a resolution of each House of Parliament, in accordance with paragraphs 8F(1)f2 and 12(1) of Schedule 7 to that Act.

The Treasury has consented to the making of these Regulations as required by paragraph 3(1) of Schedule 4 to that Act.

Annotations to the whole text

Footnotes

f1

2018 c.16. The European Union (Withdrawal) Act 2018 was amended by the European Union (Withdrawal Agreement) Act 2020 (c. 1) (“the 2020 Act”). Section 8C was inserted by section 21 of the 2020 Act, and paragraph 1(1)(ab) of Schedule 4 by section 28 of that Act. Paragraph 21 of Schedule 7 was amended by paragraph 53(2) of Schedule 5 to the 2020 Act.

f2

Paragraph 8F was inserted by paragraph 51 of Schedule 5 to the 2020 Act.

Contents

  1. Part 1: Preliminary
  2. 1Citation and commencement
  3. 2Extent and application
  4. 3Interpretation
  5. 4Scope
  6. Part 2A: Making available on the market and putting into service under Regulation (EU) 2017/746
  7. 10ACertificates of free sale under Regulation (EU) 2017/746 – fee
  8. 10BRetention of documentation relating to conformity assessments
  9. 10CUK(NI) indication under Regulation (EU) 2017/746
  10. A11Legal representatives and contact persons for clinical investigations
  11. 17AAdvice in relation to intended clinical investigations
  12. Part 3A: Performance studies under Regulation (EU) 2017/746
  13. 17BLegal representatives and contact persons for performance studies
  14. 17CEthical review of performance studies
  15. 17DArbitration following the refusal of a performance study application
  16. 17EDamage compensation in relation to performance studies
  17. 17FRetention of documentation relating to performance studies
  18. Part 4: Notified bodies designated under Regulation (EU) 2017/745 and Regulation (EU) 2017/746
  19. 18Notified bodies
  20. 19Fees payable in connection with the designation of notified bodies
  21. Part 4A: Fees for consultation in relation to the safety, quality and usefulness of a medicinal substance incorporated in a device
  22. 19AInterpretation of Part 4A
  23. 19BCircumstances 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
  24. 19CFees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a device
  25. 19DFees for pre-consultation meetings Repealed
  26. Part 5: General provision about language requirements and fees
  27. 20Language requirements
  28. 21Unpaid fees
  29. 22Waivers, reductions and refunds
  30. Part 7: Amendment of primary legislation
  31. 27Investigatory powers under the Consumer Rights Act 2015
  32. 28Amendment of the Medicines and Medical Devices Act 2021
  33. Part 8: Amendment of the Medical Devices Regulations 2002
  34. 29Amendments to the Medical Devices Regulations 2002
  35. 30Amendment of regulation 2 (interpretation)
  36. 31Amendment of regulation 2A (medical devices which are qualifying Northern Ireland goods)
  37. 32Revocation and transitional provision
  38. 33Amendment of regulation 10A (UK(NI) indication: general medical devices)
  39. 34Amendment of regulation 19 (registration of persons placing general medical devices on the market)
  40. 35Amendment of regulation 21B (registration of persons placing active implantable medical devices on the market)
  41. 36Amendment of regulation 24A (UK(NI) indication: active implantable medical devices)
  42. 37Amendment of regulation 36A (UK(NI) indication: in vitro diagnostic medical devices)
  43. Part 9: Amendments of other secondary legislation
  44. 38Amendment of the Blood Safety and Quality Regulations 2005
  45. 39Amendment of the Human Tissue (Quality and Safety for Human Application) Regulations 2007
  46. 40Amendment of the Legislative and Regulatory Reform (Regulatory Functions) Order 2007
  47. 41Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016
  48. 42Amendment of the Economic Growth (Regulatory Functions) Order 2017
  49. Signature
  50. Schedule 2Fees in connection with the designation of notified bodies
  51. Explanatory note

1Citation and commencementI1

(1)

These Regulations may be cited as the Medical Devices (Northern Ireland Protocol) Regulations 2021.

(2)

These Regulations come into force on the day after the day on which they are made.

2Extent and applicationI1

(1)

Parts 1, 4, 5, 7 and 8 extend to England and Wales, Scotland and Northern Ireland.

(2)

Parts 2, F12A, 3 F2, 3A and 6 extend to Northern Ireland only.

(3)

Any amendment made by Part 9 has the same extent as the provision amended.

(4)

In Part 8—

(a)

Regulations 30, and 32 to 37 apply in relation to Northern Ireland only;

(b)

Regulation 31 applies in relation to Great Britain only.

3InterpretationI1

(1)

In these Regulations—

  • “Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5th April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EECf1;

  • F1“Regulation (EU) 2017/746” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU;

  • “ethics committee” means a research ethics committee recognised or established by, or on behalf of, the Scottish Ministers, the Welsh Ministers, the Department of Health in Northern Ireland or the Health Research Authorityf2.

  • F2“Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators;

  • “UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020.

F3(2)

Unless otherwise defined in these Regulations—

(a)

terms used in Parts 2 and 3 have the same meaning as in Regulation (EU) 2017/745;

(b)

terms used in Parts 2A and 3A have the same meaning as in Regulation (EU) 2017/746.

F4(3)

In these Regulations, a reference to an Article or an Annex is—

(a)

in Parts 2 and 3, a reference to an Article or an Annex of Regulation (EU) 2017/745;

(b)

in Parts 2A and 3A, a reference to an Article or an Annex of Regulation (EU) 2017/746.

4ScopeF1I1

In these Regulations—

(a)

Parts 4, 5 and 6 apply to all devices to which Regulation (EU) 2017/745 and Regulation (EU) 2017/746 apply;

(b)

Parts 2 and 3 apply to all devices to which Regulation (EU) 2017/745 applies;

(c)

Parts 2A and 3A apply to all devices to which Regulation (EU) 2017/746 applies.

10ACertificates of free sale under Regulation (EU) 2017/746 – feeF1

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.

10BRetention of documentation relating to conformity assessmentsF1

(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.

10CUK(NI) indication under Regulation (EU) 2017/746F1

(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.

A11Legal representatives and contact persons for clinical investigationsF1

(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.

17AAdvice in relation to intended clinical investigationsF1

(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)

F2£987 for a regulatory advice meeting under paragraph (1)(a); and

(b)

F3£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.

17BLegal representatives and contact persons for performance studiesF1

(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.

17CEthical review of performance studiesF1

(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.

17DArbitration following the refusal of a performance study applicationF1

(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).

17EDamage compensation in relation to performance studiesF1

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.

17FRetention of documentation relating to performance studiesF1

(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.

18Notified bodiesI1

(1)

The Secretary of State is the appointed authority responsible for notified bodies under Article 35 F1of Regulation (EU) 2017/745 and Article 31 of Regulation (EU) 2017/746.

(2)

In the event of restriction, suspension, or withdrawal of a designation, the notified body must provide the Secretary of State with any documents requested for the purposes of enabling the Secretary of State to exercise the functions of the authority responsible for notified bodies under Article 46(6) F2of Regulation (EU) 2017/745 and Article 42(6) of Regulation (EU) 2017/746.

19Fees payable in connection with the designation of notified bodiesI1

(1)

Fees in connection with the designation of notified bodies are set out in Schedule 2.

(2)

The applicant must pay the Secretary of State the fee specified in table 1 in Schedule 2 for an application—

(a)

for initial designation as a notified body under Article 38 F1of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746;

(b)

for reassessment under Article 44(10) F2of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746;

(c)

to extend the scope of a designation under Article 46(1) F3of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746.

(3)

A notified body designated by the Secretary of State under Article 42 F4of Regulation (EU) 2017/745 that submits a summary evaluation report to the Secretary of State in accordance with Article 5(4) of Regulation (EU) 722/2012, must pay to the Secretary of State a fee of F5£1,503.

(4)

A fee specified in table 1 in Schedule 2 or paragraph (3) is payable when the application or submission to which it relates is made to the Secretary of State.

(5)

If an applicant fails to pay a fee specified in table 1 in Schedule 2 or paragraph (3), the Secretary of State may reject the application or submission to which it relates.

(6)

If the Secretary of State conducts an assessment or review listed in table 2 in Schedule 2, the fee payable by the conformity assessment body is—

(a)

the fee specified for that assessment or review in table 2 in Schedule 2,

(b)

an amount for time spent by each member of staff to undertake the assessment or review at a rate—

(i)

for the time spent on site, of F6£732 per half day (period of less than a half day counting as a half day) up to a maximum of 2 half days on any one date, and

(ii)

for the time spent travelling to and from the site, of F7£198 per hour,

(c)

the actual costs of travel, accommodation and subsistence, and

(d)

out of pocket expenses.

(7)

A fee under paragraph (6) is payable within one month of receipt by the conformity assessment body of a written notice from the Secretary of State requiring payment of the fee.

(8)

If a conformity assessment body fails to pay a fee under paragraph (6), the Secretary of State may—

(a)

refuse to designate the body under Article 42 F8of Regulation (EU) 2017/745 or Article 38 of Regulation (EU) 2017/746;

(b)

if the body has already been designated, suspend, restrict, or fully or partially withdraw, the designation.

(9)

In this regulation, “Regulation (EU) 722/2012” means Commission Regulation (EU) No 722/2012 of 8th August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal originf1.

19AInterpretation of Part 4AF1

In this Part—

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

    1. (a)

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

    2. (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—

    1. (a)

      discover or verify the effects of such a substance,

    2. (b)

      identify any adverse reaction to such a substance, or

    3. (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—

    1. (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;

    2. (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

    3. (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—

      1. (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

      2. (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—

    1. (a)

      an authorised medicinal product;

    2. (b)

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

    3. (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.

19BCircumstances in which a fee is payable in relation to a consultation on the safety, quality and usefulness of a medicinal substance incorporated in a deviceF1

(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.

19CFees payable in connection with a consultation or further consultation on the safety, quality and usefulness of a medicinal substance incorporated in a deviceF1

(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)

F2£4,953 if each medicinal substance is manufactured by an approved manufacturer of that substance;

(b)

F3£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)

F4£980 if each medicinal substance is manufactured by an approved manufacturer of that substance;

(b)

F5£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)

F6£50,644 for a consultation; and

(b)

F7£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.

19DFees for pre-consultation meetingsF1

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

20Language requirementsI1

Where Regulation (EU) 2017/745 F1or Regulation (EU) 2017/746 provide for the UK in respect of Northern Ireland to determine the language requirements for information and documentation, such information and documentation must be written in English.

21Unpaid feesI1

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

22Waivers, reductions and refundsI1

The Secretary of State may—

(a)

waive payment of any fee or reduce any fee or part of a fee otherwise payable under these Regulations;

(b)

refund the whole or part of any fee paid pursuant to these Regulations.

27Investigatory powers under the Consumer Rights Act 2015I1

(1)

Schedule 5 to the Consumer Rights Act 2015f1(investigatory powers etc) is amended in accordance with this regulation.

(2)

In paragraph 8 (interpretation of Schedule 5), after the definition of “online interface order” insert—

(3)

In paragraph 10 (enforcer’s legislation: duties and powers mentioned in paragraph 9(1)(a)) at the end insert “regulation 26 of the Medical Devices (Northern Ireland Protocol) Regulations 2021”.

(4)

In paragraph 19 (exercise of powers in Part 4), in sub-paragraph (7A)(a)f2, for the words from “a breach of” to the end substitute—

“a breach of—

(i)

the Medical Devices Regulations 2002 (S.I. 2002/618),

(ii)

regulations made under section 15(1) of the Medicines and Medical Devices Act 2021,

(iii)

the Medical Devices (Northern Ireland Protocol) Regulations 2021, or

(iv)

Regulation (EU) 2017/745 on medical devices, and”.

(5)

In paragraph 30Af3 (power to decommission or switch off fixed medical devices)—

(a)

in sub-paragraph (1), for the words from “pursuant to” to the end substitute—

“pursuant to—

(a)

the duty in regulation 61(1A) or (1B) of the Medical Devices Regulations 2002 (S.I. 2002/618),

(b)

a duty in regulations made under section 15(1) of the Medicines and Medical Devices Act 2021, or

(c)

the duty in regulation 26 of the Medical Devices (Northern Ireland Protocol) Regulations 2021.”;

(b)

in sub-paragraph (2), for “medical device to which the Medical Devices Regulations 2002 apply” substitute “relevant medical device”;

(c)

after sub-paragraph (2), insert—

“(3)

In sub-paragraph (2), “relevant medical device” means—

(a)

where a domestic enforcer is acting pursuant to a duty mentioned in sub-paragraph (1)(a) or (b), any medical device to which the Medical Devices Regulations 2002 apply;

(b)

where a domestic enforcer is acting pursuant to the duty mentioned in sub-paragraph (1)(c), any medical device to which Regulation (EU) 2017/745 on medical devices applies.”

28Amendment of the Medicines and Medical Devices Act 2021I1

(1)

The Medicines and Medical Devices Act 2021f1 is amended in accordance with this regulation.

(2)

In section 17 (fees, information, offences), in subsection (2), for “this Part” substitute “this Chapter”.

(3)

In section 21 (compliance notices), after subsection (1), insert—

“(1A)

In this Chapter, “medical devices provision” means a provision in—

(a)

regulations under section 15(1),

(b)

the Medical Devices Regulations 2002 (S.I. 2002/618),

(c)

the Medical Devices (Northern Ireland Protocol) Regulations 2021, or

(d)

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.”

(4)

In section 34 (recovery of expenses of enforcement), in subsection (1)(a), for the words from “offence under” to the end substitute—

“offence under—

(i)

section 28,

(ii)

regulation 60A of the Medical Devices Regulations 2002 (S.I. 2002/618) (offence of breaching certain provisions in the Regulations), or

(iii)

regulation 23 of the Medical Devices (Northern Ireland Protocol) Regulations 2021 (offence of breaching certain provisions),

in relation to a medical device, or”.

(5)

In section 39 (disclosure of information)—

(a)

in subsection (10)(a), omit the “or” at the end;

(b)

in subsection (10)(b), at the end insert—

“, or

(c)

contravenes any obligation or restriction created or arising by or under the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement, whether or not an obligation or restriction to which section 7A(2) of the European Union (Withdrawal) Act 2018 applies.”.

(6)

In section 42 (interpretation of Part 4), in subsection (2)—

(a)

for the definition of “manufacturer” substitute—

(b)

for the definition of “medical devices provision” substitute—

  • ““medical devices provision”—

    1. (a)

      in Chapter 1, has the meaning given by section 17(2), and

    2. (b)

      in Chapter 3, has the meaning given by section 21(1A);”.

(7)

In Schedule 2 (medical devices: civil sanctions)—

(a)

in paragraph 1(1) (imposition of monetary penalty)—

(i)

in paragraph (a), omit the “or” at the end;

(ii)

in paragraph (b), at the end insert—

“, or

(c)

regulation 23 of the Medical Devices (Northern Ireland Protocol) Regulations 2021 (offence of breaching certain provisions).”;

(b)

in paragraph 4 (monetary penalties: criminal proceedings and conviction)—

(i)

in sub-paragraph (1)(a), from “offence under” to the end substitute—

“offence under—

(i)

section 28,

(ii)

regulation 60A of the Medical Devices Regulations 2002, or

(iii)

regulation 23 of the Medical Devices (Northern Ireland Protocol) Regulations 2021,

may be instituted against the person in respect of the act or omission to which the notice relates before the end of the period within which the person’s liability may be discharged as mentioned in paragraph 2(2) (see paragraph 3(2)(a));”;

(ii)

in sub-paragraph (1)(b), from “section 28” to the end substitute “the provisions mentioned in paragraph (a) in relation to that act or omission.”;

(iii)

in sub-paragraph (2), from “section 28” to the end substitute “any of the provisions mentioned in sub-paragraph (1)(a) in respect of the act or omission giving rise to the penalty.”;

(c)

paragraph 5 (enforcement undertakings)—

(i)

in sub-paragraph (1)(a), from “offence under” to the end substitute—

“offence under—

(i)

section 28,

(ii)

regulation 60A of the Medical Devices Regulations 2002, or

(iii)

regulation 23 of the Medical Devices (Northern Ireland Protocol) Regulations 2021,”;

(ii)

in sub-paragraph (2)(a), from “section 28” to the end substitute “any of the provisions mentioned in sub-paragraph (1)(a) in respect of the act or omission to which the undertaking relates;”;

(d)

in paragraph 13 (guidance as to enforcement), in sub-paragraph (1)(a), for “or regulation 60A” to the end substitute “, regulation 60A of the Medical Devices Regulations 2002 or regulation 23 of the Medical Devices (Northern Ireland Protocol) Regulations 2021;”.

29Amendments to the Medical Devices Regulations 2002I1

The Medical Devices Regulations 2002f1 are amended in accordance with this Part.

30Amendment of regulation 2 (interpretation)I1

In regulation 2, in paragraph (1)—

(a)

for the definition of “medical device” substitute—

  • ““medical device” has the meaning given in Article 2(1) of Regulation (EU) 2017/745 and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device;”;

(b)

after the definition of “Regulation 722/2012” insert—

31Amendment of regulation 2A (medical devices which are qualifying Northern Ireland goods)I1

In regulation 2A—

(a)

in paragraph (1)(a), after “Northern Ireland” insert “or of Regulation (EU) 2017/745”;

(b)

in paragraph (2)—

(i)

the words from ““qualifying Northern Ireland good”” to the end become sub-paragraph (a); and

(ii)

after that sub-paragraph insert—

“(b)

“Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.”.

32Revocation and transitional provisionI1

After regulation 3 (scope), insert—

“Revocation, transitional and saving provisions in respect of Regulation (EU) 2017/745

3ZA.
(1)

Subject to paragraph (2)—

(a)

Parts 2 and 3 only apply in Northern Ireland for the purposes of regulating qualifying devices.

(b)

Parts 5 to 7 only apply in Northern Ireland for the purposes of regulating qualifying devices and devices within the scope of Part 4.

(2)

The following provisions continue to apply in Northern Ireland in accordance with this paragraph whether or not the device to which they apply is referred to in paragraph (1)—

(a)

for the purposes of registration of medical devices and persons placing medical devices on the market in Northern Ireland—

(i)

regulation 19 (registration of persons placing general medical devices on the market),

(ii)

regulation 21B (registration of persons placing active implantable medical devices on the market), and

(iii)

regulation 53 (fees in connection with the registration of devices and changes to registration details),

apply until the date which is 6 months after the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745.

(b)

Parts 5 to 7 apply for purposes related to the designation of conformity assessment bodies for the purposes of a UK mutual recognition agreement.

(3)

For the purposes of paragraph (1), a device is a qualifying device if, by virtue of Article 120 of Regulation (EU) 2017/745—

(a)

it may be placed on the market, put into service or made available in Northern Ireland in accordance with the requirements of Directive 93/42 or Directive 90/385, rather than Regulation (EU) 2017/745; and

(b)

it is placed on the market, put into service or made available in Northern Ireland in accordance with, and subject to the requirements of and the arrangements set out in, Parts 2, 3 and 5 to 7.”

33Amendment of regulation 10A (UK(NI) indication: general medical devices)I1

In regulation 10A, after paragraph (3), insert—

“(3A)

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

34Amendment of regulation 19 (registration of persons placing general medical devices on the market)I1

In regulation 19—

(a)

omit paragraph (1)(a)(ii);

(b)

in paragraph (1)(b) for “and custom-made devices” substitute “that are not custom-made devices”;

(c)

omit paragraph (2)(c);

(d)

omit paragraph (5); and

(e)

omit paragraph (6).

35Amendment of regulation 21B (registration of persons placing active implantable medical devices on the market)I1

In regulation 21B—

(a)

omit paragraph (1)(a)(ii);

(b)

omit paragraph (1)(b);

(c)

omit paragraph (2)(c);

(d)

omit paragraph (5); and

(e)

omit paragraph (6).

36Amendment of regulation 24A (UK(NI) indication: active implantable medical devices)I1

In regulation 24A, after paragraph (3), insert—

“(3A)

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

37Amendment of regulation 36A (UK(NI) indication: in vitro diagnostic medical devices)I1

In regulation 36A, after paragraph (3), insert—

“(3A)

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

38Amendment of the Blood Safety and Quality Regulations 2005I1

In the Blood Safety and Quality Regulations 2005f1, in regulation 2 (scope of the regulations), in paragraph (3), at the end insert “and Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC”.

39Amendment of the Human Tissue (Quality and Safety for Human Application) Regulations 2007I1

In the Human Tissue (Quality and Safety for Human Application) Regulations 2007f1, in regulation 2 (extent and application)—

(a)

in paragraph (3)(c), omit the “or” at the end; and

(b)

in paragraph (3)(d), at the end insert—

“, or

(e)

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.”

40Amendment of the Legislative and Regulatory Reform (Regulatory Functions) Order 2007I1

(1)

The Legislative and Regulatory Reform (Regulatory Functions) Order 2007f1 is amended as follows.

(2)

In Part 2 of the Schedule, in the section headed “Medicines”, after “Human Medicines Regulations 2012”, insert—

(3)

In Part 3 of the Schedule, in the section headed “Public health and safety”, after “The Personal Protective Equipment (Enforcement) Regulations 2018”, insert “The Medical Devices (Northern Ireland Protocol) Regulations 2021”.

41Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016I1

In the Medicines (Products for Human Use) (Fees) Regulations 2016f1, in regulation 10(5) (fee for advice for other purposes)—

(a)

in paragraph (a), omit the “or” at the end; and

(b)

in paragraph (b), at the end insert—

“; or

(c)

obtaining an EU technical documentation assessment certificate or EU type-examination certificate of the type mentioned in section 5 of Annex IX and section 6 of Annex X of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, for a medical device incorporating that product or a product of that type.”

42Amendment of the Economic Growth (Regulatory Functions) Order 2017I1

In the Economic Growth (Regulatory Functions) Order 2017f1, in Part 3 of the Schedule, in the section headed “Medicines”, after “Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004”, insert—

Signature

Signed by authority of the Secretary of State for Health and Social Care.

Nadhim Zahawi

Parliamentary Under-Secretary of State,

Department of Health and Social Care

26th July 2021

We consent

Alan Mak

David Rutley

Two Lords Commissioners of Her Majesty’s Treasury

21st July 2021

Schedule 2Fees in connection with the designation of notified bodiesI1

Table 1

Application fees

ApplicationFee
1. For initial designation submitted under Article 38 F1of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746F2£41,337
2. For initial designation re-submitted under Article 38 F3of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746 where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the applicationF4£10,335
3. For reassessment under Article 44(10) F5of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746F6£41,337
F74. For an extension of the scope of the designation under Article 46(1) F8of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746 which extends the body’s designation to carry out tasks included in an Annex F9to Regulation (EU) 2017/745 or Regulation (EU) 2017/746 that was not previously within the body’s designationF10£14,568
F115. For an extension of the scope of the designation under Article 46(1) F12of Regulation (EU) 2017/745 or Article 42(1) of Regulation (EU) 2017/746 which extends the body’s designation to carry out 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 requiredF13£21,105

Table 2

Fees for assessments and reviews

ActivityFee
1. On-site assessment under Article 39(4) F14of Regulation (EU) 2017/745 or Article 35(4) of Regulation (EU) 2017/746 in connection with an application for initial designation under Article 38 F15of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746, or an application for reassessment under Article 44(10) F16of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746F17£67,606
2. On-site audit as part of an annual reassessment under Article 44(4) F18of Regulation (EU) 2017/745 or Article 40(4) of Regulation (EU) 2017/746F19£52,929
3. Observed audit of notified body personnel under Article 44(5) F20of Regulation (EU) 2017/745 or Article 40(5) of Regulation (EU) 2017/746F21£11,672
4. On-site assessment of a subsidiaryF22£26,408

5. ‘For-cause’ review under Article 44(7) F23of Regulation (EU) 2017/745 or Article 40(7) of Regulation (EU) 2017/746 to—

(a) review assessments by the notified body, including clinical evaluation documentation;

(b) otherwise verify compliance with the requirements of Regulation (EU) 2017/745 F24, or Regulation (EU) 2017/746 or address a particular issue

(a) F25£21,535

(b) F26£26,408

Explanatory note

(This note is not part of the Regulations)

These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017) (“Regulation (EU) 2017/745”). Article 5(4) of the Protocol on Ireland/Northern Ireland to the Withdrawal Agreement between the United Kingdom and the European Union (“the Protocol”) provides that the EU law listed in Annex 2 to the Protocol will apply to and in the UK, in respect of Northern Ireland. Regulation (EU) 2017/745 is listed in Annex 2 and applied from 26 May 2021. Section 7A of the European Union (Withdrawal) Act 2018 gives effect to Regulation (EU) 2017/745 in domestic law.

Part 2 of these Regulations makes supplementary provision in relation to placing devices on the market and putting devices into service in Northern Ireland under Regulation (EU) 2017/745.

Part 3 makes provision in relation to clinical investigations in Northern Ireland under Regulation (EU) 2017/745. Regulation 16 and Schedule 1 set out the fees for making applications and notifying of substantial modifications.

Part 4 of these Regulations makes provision in relation to notified bodies. It provides that the Secretary of State is the authority responsible for notified bodies under Article 35 of Regulation (EU) 2017/745. Regulation 19 and Schedule 2 set out the fees for making applications and for on-site assessments and reviews.

Part 5 makes general provision about language requirements and the fees imposed by these Regulations.

Part 6 deals with enforcement. Regulation 23 makes it a criminal offence to breach a prohibition or requirement in a provision listed in Table 1 or Table 2 in Schedule 3. Table 1 lists regulations in these Regulations and Table 2 lists Articles in Regulation (EU) 2017/745. Regulation 26 confers duties on the Secretary of State and each district council in Northern Ireland to enforce these Regulations and Regulation (EU) 2017/745.

Part 7 amends the Consumer Rights Act 2015 and the Medicines and Medical Devices Act 2021.

Part 8 amends the Medical Devices Regulations 2002. Regulation 32 revokes parts of the Medical Devices Regulations 2002 as they apply to Northern Ireland, and makes transitional provision. The Medical Devices Regulations 2002 implemented Directives 90/385/EEC and 93/42/EEC, which are repealed by Regulation (EU) 2017/745. Regulations 33, 36 and 37 insert provision about the size of the UK(NI) indication. The requirement to affix the UK(NI) indication is imposed by Article 7(3) of the Protocol.

Part 9 makes consequential amendments to other pieces of secondary legislation.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private, public or voluntary sector is foreseen. The Explanatory Memorandum is published alongside these Regulations on www.legislation.gov.uk.