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The Medical Devices (Northern Ireland Protocol) Regulations 2021

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Changes over time for: The Medical Devices (Northern Ireland Protocol) Regulations 2021 (Schedules only)

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Regulation 16

SCHEDULE 1N.I.Fees for clinical investigations

Commencement Information

I1Sch. 1 in force at 27.7.2021, see reg. 1(2)

Table 1

[F1Clinical investigation of a class I device, class IIa device or class IIb device, which is neither an implantable device nor a long-term invasive device]

ActivityFee
1. Application submitted under Article 70(1)[F2£7,472]
2. Application re-submitted under Article 70(1) where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the application under Article 71(4)[F3£5,711]
3. Notification of a substantial modification under Article 75(1)£207

Table 2

[F4Clinical investigation of a class IIb device, which is either an implantable device or a long-term invasive device, or a class III device]

ActivityFee
1. Application submitted under Article 70(1)[F5£15,627]
2. Application re-submitted under Article 70(1) where the changes from the immediately preceding application are limited to addressing the grounds on which the Secretary of State previously refused the application under Article 71(4)[F6£11,069]
3. Notification of a substantial modification under Article 75(1)£331

Regulation 19

SCHEDULE 2U.K.Fees in connection with the designation of notified bodies

Commencement Information

I2Sch. 2 in force at 27.7.2021, see reg. 1(2)

Table 1

Application fees

ApplicationFee
1. For initial designation submitted under Article 38 [F7of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746][F8£35,672]
2. For initial designation re-submitted under Article 38 [F9of 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 application[F10£8,918]
3. For reassessment under Article 44(10) [F11of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746][F12£35,672]
[F134. For an extension of the scope of the designation under Article 46(1) [F14of 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 [F15to Regulation (EU) 2017/745 or Regulation (EU) 2017/746] that was not previously within the body’s designation][F16£12,571]
[F175. For an extension of the scope of the designation under Article 46(1) [F18of 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 required][F19£18,212]

Textual Amendments

Table 2

Fees for assessments and reviews

ActivityFee
1. On-site assessment under Article 39(4) [F20of Regulation (EU) 2017/745 or Article 35(4) of Regulation (EU) 2017/746] in connection with an application for initial designation under Article 38 [F21of Regulation (EU) 2017/745 or Article 34 of Regulation (EU) 2017/746], or an application for reassessment under Article 44(10) [F22of Regulation (EU) 2017/745 or Article 40(10) of Regulation (EU) 2017/746][F23£58,341]
2. On-site audit as part of an annual reassessment under Article 44(4) [F24of Regulation (EU) 2017/745 or Article 40(4) of Regulation (EU) 2017/746][F25£45,675]
3. Observed audit of notified body personnel under Article 44(5) [F26of Regulation (EU) 2017/745 or Article 40(5) of Regulation (EU) 2017/746][F27£10,072]
4. On-site assessment of a subsidiary[F28£22,789]

5. ‘For-cause’ review under Article 44(7) [F29of 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 [F30, or Regulation (EU) 2017/746] or address a particular issue

(a) [F31£18,583]

(b) [F32£22,789]

Textual Amendments

Regulation 23

SCHEDULE 3N.I.Provisions breach of which is an offence under regulation 23

Commencement Information

I3Sch. 3 in force at 27.7.2021, see reg. 1(2)

[F33Table 1

RegulationTitle of the regulation
5Reprocessing of single-use devices
6Requirement on health institutions relating to implanted devices
7Provision of information relating to custom-made devices
9Retention of documentation relating to conformity assessments and custom-made devices
10UK(NI) indication under Regulation (EU) 2017/745
10BRetention of documentation relating to conformity assessments
10CUK(NI) indication under Regulation (EU) 2017/746
11Ethical review of clinical investigations
12(1)Prior authorisation of clinical investigations by the Secretary of State
14Damage compensation in relation to clinical investigations
15Retention of documentation relating to clinical investigations
17CEthical review of performance studies
17EDamage compensation in relation to performance studies
17FRetention of documentation relating to performance studies]

Table 2

ArticleTitle of the article
5(1) to (3), (5)Placing on the market and putting into service
6(1)-(3)Distance sales
7Claims
9(3), (4)Common specifications
10 (except in paragraph 14, only the first sub-paragraph) [F34general obligations of manufacturers]
11(1), (3), (6)Authorised representative
12Change of authorised representative
13General obligations of importers
14General obligations of distributors
15Person responsible for regulatory compliance
16(3), (4)Cases in which obligations of manufacturers apply to importers, distributors or other persons.
17(1)Single-use devices and their reprocessing
18(1)Implant card and information to be supplied to the patient with an implanted device
21(2)Devices for special purposes
22(1), (3) to (5)Systems and procedure packs
23(1)Parts and components
25(1), (2)Identification within the supply chain
[F3532(1) (except the second sentence of the third sub-paragraph), (2)]Summary of safety and clinical performance
52(1) to (4), (6) to (11), (13)Conformity assessment procedures
53(3)Involvement of notified bodies in conformity assessment procedures
58(1)Voluntary change of notified body
62(1), (2) (only the first sub-paragraph), (3) (only the first sub-paragraph), (4), (5), (7)General requirements regarding clinical investigations conducted to demonstrate conformity of devices
82(1)Requirements regarding other clinical investigations
84Post-market surveillance plan
85Post-market surveillance report
[F3686 (except the second and third sentences of paragraph (2))]Periodic safety update report
89(1), (3) (only the second sub-paragraph),(5), (8)Analysis of serious incidents and field safety corrective actions
94 (only the final paragraph)Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance

[F37Table 3

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

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