- Latest available (Revised)
- Point in Time (31/12/2020)
- Original (As made)
Version Superseded: 01/07/2023
Point in time view as at 31/12/2020. There are multiple versions of this provision on screen. These apply to different geographical extents.This version of this provision has been superseded.
You are viewing this legislation item as it stood at a particular point in time. status_warning_revised_p22i Sometimes the text of a provision is changed, but the change(s) only apply to a particular geographical area. In some limited cases where this happens, the editorial team create a version for each different geographical area. Multiple versions are only created in this way where the change in question is a substitution so that there are different versions of the text for the different extents. A later version of this provision including subsequent changes and effects supersedes these versions.
The Medical Devices Regulations 2002, Section 44ZA is up to date with all changes known to be in force on or before 26 August 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
Changes and effects yet to be applied by the editorial team are only applicable when viewing the latest version or prospective version of legislation. They are therefore not accessible when viewing legislation as at a specific point in time. To view the ‘Changes to Legislation’ information for this provision return to the latest version view using the options provided in the ‘What Version’ box above.
44ZA—(1) In this regulation—
(a)any reference to an Article or Annex is a reference to that Article or Annex in Directive 98/79 as amended from time to time;
(b)“Regulation 722/2012” means Commission Regulation (EU) 722/2012 as it applies in the European Union;
(c)“CE marking” means the CE marking required by Article 16 and shown in Annex X;
(d)“harmonised standard” is to be construed in accordance with Article 5.
(2) Where paragraph (3) applies regulations 34, 36(1) to (4), 37 and 40 are treated as being satisfied.
(3) This paragraph applies where, before placing a relevant device on the market, the manufacturer—
(a)ensures—
(i)that the device meets the essential requirements set out in Annex I and, where applicable, Regulation (EU) 722/2012, which apply to it; or
(ii)that paragraphs (6) and (7) apply;
(b)ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 9;
(c)ensures that the documentation required by the relevant conformity assessment procedure is drawn up;
(d)ensures that the technical and other relevant documentation required by a relevant conformity assessment procedure is prepared in or translated into English;
(e)affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes III, IV, V, VI or VII;
(f)draws up an EU Declaration of Conformity in accordance with Article 9;
(g)ensures that the declaration of conformity is prepared in or translated into English.
(4) Where paragraph (5) applies, regulation 43 is treated as being satisfied.
(5) This paragraph applies where before a relevant device intended for performance evaluation is made available in Great Britain for the purpose of a performance evaluation, the manufacturer—
(a)has supplied the relevant written notice which must be in English in the form required by Sections 1 and 2 of Annex VIII;
(b)has provided an undertaking to the Secretary of State to keep available the documentation required by Annex VIII for the period specified in Section 3 of Annex VIII;
(c)has taken all necessary measures to ensure that the manufacturing process for the device produces devices in accordance with the documentation referred to in the first paragraph of Section 3 of Annex VIII.
(6) Where paragraph (7) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirements referred to in regulation 35(3) and (4).
(7) This paragraph applies where—
(a)a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard; or
(b)a relevant device is in conformity with a common technical specification.
(8) For the purpose of this regulation in regulations 36(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.]
Textual Amendments
F1Regs. 44ZA, 44ZB inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 6(10) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 46); 2020 c. 1, Sch. 5 para. 1(1)
44ZA—(1) Paragraph (2) applies in relation to a manufacturer who—
(a)does not have a registered place of business in the United Kingdom;
(b)has not designated an authorised representative who has a registered place of business in Northern Ireland; and
(c)places a relevant device a device that is an Annex II device or a device for self-testing, on the market in Northern Ireland; or
(d)makes available such a device for performance evaluation.
(2) A manufacturer to whom this paragraph applies must appoint a person with a registered place of business in the United Kingdom as their UK responsible person to carry out the tasks described in regulations 44(2) and (5).]
Extent Information
E1This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F2Regs. 44, 44ZA substituted for reg. 44 (N.I.) (31.12.2020 immediately before IP completion day) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1478), reg. 1(3), Sch. 1 para. 15
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Point in Time: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: 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.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
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.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: