The Medical Devices (Northern Ireland Protocol) Regulations 2021

JurisdictionUK Non-devolved
CitationSI 2021/905

2021 No. 905

Medical Devices

Consumer Protection

The Medical Devices (Northern Ireland Protocol) Regulations 2021

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 20181, 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)2and 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.

1 Preliminary

PART 1

Preliminary

S-1 Citation and commencement

Citation and commencement

1.—(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.

S-2 Extent and application

Extent and application

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

(2) Parts 2, 3 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)

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

(b)

(b) Regulation 31 applies in relation to Great Britain only.

S-3 Interpretation

Interpretation

3.—(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 178/2002and Regulation (EC) No 1223/2009and repealing Council Directives 90/385/EECand 93/42/EEC3;

“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 Authority4.

(2) Unless otherwise defined in these Regulations, terms used have the same meaning as in Regulation (EU) 2017/745.

(3) In these Regulations a reference to—

(a)

(a) an Article is a reference to an Article of Regulation (EU) 2017/745;

(b)

(b) an Annex is a reference to an Annex to Regulation (EU) 2017/745.

S-4 Scope

Scope

4. These Regulations apply to all devices to which Regulation (EU) 2017/745 applies.

2 Making available on the market and putting into service under Regulation (EU) 2017/745

PART 2

Making available on the market and putting into service under Regulation (EU) 2017/745

S-5 Reprocessing of single-use devices

Reprocessing of single-use devices

5. The reprocessing and further use of single-use devices is permitted only when it is carried out in accordance with Article 17.

S-6 Requirement on health institutions to provide information relating to implanted devices

Requirement on health institutions to provide information relating to implanted devices

6. A health institution which has implanted a device to which Article 18 applies, must make available to the patient in whom the device has been implanted—

(a) the implant card for the device bearing the health institution’s identity, and

(b) the information provided by the manufacturer with the device pursuant to Article 18(1), by any means that allow rapid access to that information.

S-7 Registration of custom-made devices

Registration of custom-made devices

7.—(1) A manufacturer who makes custom-made devices available on the market in Northern Ireland must register that type of device with the Secretary of State.

(2) Registration—

(a)

(a) must take place within 28 days beginning with the day on which that type of device is first made available on the market, and

(b)

(b) requires the manufacturer to submit to the Secretary of State the information specified in paragraph (3).

(3) The information to be submitted to the Secretary of State is—

(a)

(a) the name, business address and contact details of the manufacturer of the device;

(b)

(b) if an authorised representative has been designated by the manufacturer, the authorised representative’s name, business address, contact details and evidence of that designation;

(c)

(c) a description of the type of device concerned.

(4) The manufacturer must ensure that the information submitted to the Secretary of State remains up to date.

(5) The fee payable to the Secretary of State for registering a device or amending the registration of a device under this regulation is £100.

(6) This regulation does not apply before 1st September 2021 in respect of any class IIa or class IIb non-implantable devices made available on the market by a manufacturer who is not established in the United Kingdom.

S-8 Certificates of free sale - fee

Certificates of free sale - fee

8. A manufacturer or authorised representative who requests a certificate of free sale from the Secretary of State under Article 60(1), must pay to the Secretary of State a fee of £75.

S-9 Retention of documentation relating to conformity assessments and custom-made devices

Retention of documentation relating to conformity assessments and custom-made devices

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

(a)

(a) retain for the required period any documentation that consists of, or reasonably could consist of, information to which section 8 of Annex IX applies, and

(b)

(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)

(a) in the case of information relating to an implantable device, 15 years after the last device was placed on the market, and

(b)

(b) in any other case, 10 years after the last device was placed on the market.

S-10 UK(NI) indication

UK(NI) indication

10.—(1) This regulation applies if the CE marking is affixed in accordance with Article 20 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)

(a) visibly, legibly and indelibly, and

(b)

(b) before placing the device on the market or putting the device into service.

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

(6) In this regulation, “the 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 20205.

3 Clinical investigations under Regulation (EU) 2017/745

PART 3

Clinical investigations under Regulation (EU) 2017/745

S-11 Ethical review of clinical investigations

Ethical review of clinical investigations

11.—(1) A sponsor proposing to conduct a clinical investigation of a device in Northern Ireland must apply to an ethics committee for an ethical review of the proposed clinical investigation.

(2) 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 clinical investigation is started.

S-12 Prior authorisation of clinical investigations by the Secretary of State

Prior authorisation of clinical investigations by the Secretary of State

12.—(1) A clinical investigation to which Article 70(7)(a) applies must not start unless—

(a)

(a) it has been authorised by the Secretary of State, and

(b)

(b) a favourable opinion in respect of the clinical investigation has been issued by an ethics committee.

(2) For the purposes of paragraph (1)(a) and subject to paragraph (3), the Secretary of State must notify the sponsor of whether the clinical investigation is authorised within—

(a)

(a) 65 days of the validation date provided for in Article 70(5), if the Secretary of State decides to consult experts for advice on whether the clinical investigation should be authorised, or

(b)

(b) 45 days of the validation date in any other case.

(3) If the Secretary of State requests additional information from the sponsor under Article 70(6), the expiry of the periods in paragraph (2) is suspended from the date of the first request until such time as the additional information has been received.

S-13 Arbitration following the refusal of a clinical investigation application

Arbitration following the refusal of a clinical investigation application

13.—(1) A sponsor notified of a refusal under Article 70(3), 71(4), or 78(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)

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

(b)

(b) authorise the clinical investigation, or

(c)

(c) in the case of a refusal under Article 70(3), proceed to consider the application under Article 70.

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

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

(6) In this regulation, “Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators.

S-14 Damage compensation in relation to clinical investigations

Damage compensation in relation to clinical investigations

14. A sponsor of a clinical investigation must hold sufficient insurance (or equivalent...

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