- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (a wnaed Fel)
This version of this schedule contains provisions that are prospective.
The term provision is used to describe a definable element in a piece of legislation that has legislative effect – such as a Part, Chapter or section. A version of a provision is prospective either:
Commencement Orders listed in the ‘Changes to Legislation’ box as not yet applied may bring this prospective version into force.
There are currently no known outstanding effects for the The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, SCHEDULE 2.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
Regulation 3
1. In this Schedule, “the 2002 Regulations” means the Medical Devices Regulations 2002 M1.
Commencement Information
I1Sch. 2 para. 1 in force at 31.12.2020 immediately before IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Marginal Citations
M1S.I. 2002/618; relevant amendments were made by S.I. 2019/791.
2.—(1) Regulation 3 is amended as follows.
(2) In paragraph (6), in inserted regulation 3A of the 2002 Regulations (designated standard)—
(a)for paragraph (1), substitute—
“(1) In [F1Parts II, III and IV] of these Regulations, a “designated standard” means—
(a)a technical specification which is—
(i)adopted by a recognised standardisation body, for repeated or continuous application with which compliance is not compulsory; and
(ii)designated by the Secretary of State by publishing a reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate; or
(b)a monograph of the European Pharmacopoeia (in particular on surgical sutures and on the interaction between medicinal products and materials used in devices containing medicinal products) which has been published in the Official Journal of the European Union.”;
(b)in paragraph (3)(b), for “(CENLAC)” substitute, “ (CENELEC) ”;
(c)for paragraph (8), substitute—
“(8) In this regulation—
(a)a reference to a “device” is a reference to a medical device or its accessory or an in vitro diagnostic medical device or its accessory to which these Regulations apply;
(b)a reference to “the European Pharmacopoeia” is a reference to the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia.”M2.
F2(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F1Words in Sch. 2 para. 2(2)(a) substituted (9.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), regs. 1(2), 4(2)(a)(i)
F2Sch. 2 para. 2(3) omitted (9.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), regs. 1(2), 4(2)(a)(ii)
Commencement Information
I2Sch. 2 para. 2 in force at 31.12.2020 immediately before IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Marginal Citations
M2Council of Europe (ETS No. 050), Strasbourg, 22.07.1964.
3. In regulation 4(4), in inserted regulation 7A of the 2002 Regulations (registration of persons placing general medical devices on the market), after paragraph (2), insert—
“(2A) The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.”.
Commencement Information
I3Sch. 2 para. 3 in force at 31.12.2020 immediately before IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
4. In regulation 5(3), in inserted regulation 21A of the 2002 Regulations (registration of persons placing active implantable medical devices on the market) after paragraph (2), insert—
“(2A) The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.”.
Commencement Information
I4Sch. 2 para. 4 in force at 31.12.2020 immediately before IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
5. In regulation 6(3), in inserted regulation 33A of the 2002 Regulations (registration etc. of persons placing in vitro diagnostic medical devices on the market) after paragraph (2), insert—
“(2A) The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.”.
Commencement Information
I5Sch. 2 para. 5 in force at 31.12.2020 immediately before IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Prospective
F36. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F3Sch. 2 para. 6 omitted (9.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), regs. 1(2), 4(2)(b)
7. In regulation 8, for paragraph (4), substitute—
“(4) In regulation 55 M3 (fees payable in connection with the designation etc. of EC conformity assessment bodies)—
(a)in the heading omit “EC”;
(b)in paragraph (1), for “an EC CAB” substitute “ a CAB ”;
(c)in paragraph (3)—
(i)for “an EC CAB” substitute “ a CAB ”;
(ii)for “the Mutual Recognition Agreements” substitute “ a mutual recognition agreement ”.”.
Commencement Information
I6Sch. 2 para. 7 in force at 31.12.2020 immediately before IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Marginal Citations
8. In regulation 9(3) (amendment of regulation 60 of the 2002 Regulations), for sub-paragraph (d), substitute—
“(d)in paragraph (4)—
(i)for “an authorised representative of a manufacturer of a device” substitute “ a UK responsible person ”;
(ii)for “the single authorised representative of the manufacturer” substitute “ a UK responsible person ”.”.
Commencement Information
I7Sch. 2 para. 8 in force at 31.12.2020 immediately before IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1
Prospective
F49. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F4Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), regs. 1(2), 4(2)(c)
Prospective
F410. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F4Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), regs. 1(2), 4(2)(c)
Prospective
F411. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Textual Amendments
F4Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), regs. 1(2), 4(2)(c)
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.
Rhychwant ddaearyddol: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Dangos Llinell Amser Newidiadau: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
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.
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:
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
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:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys