Chwilio Deddfwriaeth

The Medical Devices (Northern Ireland Protocol) Regulations 2021

Status:

Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol).

Amendment of the Medicines and Medical Devices Act 2021

This adran has no associated Memorandwm Esboniadol

28.—(1) The Medicines and Medical Devices Act 2021(1) 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—

“manufacturer” means any person who is a manufacturer for the purposes of any provision in—

(a)

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

(b)

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;;

(b)for the definition of “medical devices provision” substitute—

“medical devices provision”—

(a)

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

(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;”.

Yn ôl i’r brig

Options/Help

Print Options

Close

Mae deddfwriaeth ar gael mewn fersiynau gwahanol:

Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.

Gwreiddiol (Fel y’i Deddfwyd neu y’i Gwnaed): Mae'r wreiddiol fersiwn y ddeddfwriaeth fel ag yr oedd pan gafodd ei deddfu neu eu gwneud. Ni wnaed unrhyw newidiadau i’r testun.

Close

Dewisiadau Agor

Dewisiadau gwahanol i agor deddfwriaeth er mwyn gweld rhagor o gynnwys ar y sgrin ar yr un pryd

Close

Memorandwm Esboniadol

Mae Memoranda Esboniadol yn nodi datganiad byr o ddiben Offeryn Statudol ac yn rhoi gwybodaeth am ei amcan polisi a goblygiadau polisi. Maent yn ceisio gwneud yr Offeryn Statudol yn hygyrch i ddarllenwyr nad oes ganddynt gymhwyster cyfreithiol, ac maent yn cyd-fynd ag unrhyw Offeryn Statudol neu Offeryn Statudol Drafft a gyflwynwyd ger bron y Senedd o Fehefin 2004 ymlaen.

Close

Rhagor o Adnoddau

Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:

  • y PDF print gwreiddiol y fel deddfwyd fersiwn a ddefnyddiwyd am y copi print
  • rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
  • manylion rhoi grym a newid cyffredinol
  • pob fformat o’r holl ddogfennau cysylltiedig
  • slipiau cywiro
  • dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill
Close

Rhagor o Adnoddau

Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:

  • y PDF print gwreiddiol y fel gwnaed fersiwn a ddefnyddiwyd am y copi print
  • slipiau cywiro

liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys

  • rhestr o newidiadau a wnaed gan a/neu yn effeithio ar yr eitem hon o ddeddfwriaeth
  • manylion rhoi grym a newid cyffredinol
  • pob fformat o’r holl ddogfennau cysylltiedig
  • dolenni i ddeddfwriaeth gysylltiedig ac adnoddau gwybodaeth eraill