- Latest available (Revised)
- Original (As enacted)
There are currently no known outstanding effects for the Medicines and Medical Devices Act 2021, Section 23.
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.
(1)The enforcement authority may serve on a person a notice (“a safety notice”) imposing on the person prohibitions or requirements that the enforcement authority considers necessary to restrict the availability of a medical device in order to protect health or safety.
(2)The prohibitions that may be imposed include prohibitions on doing any of the following except with the consent of the enforcement authority—
(a)supplying the medical device;
(b)offering to supply it;
(c)agreeing to supply it;
(d)exposing it for supply;
(e)possessing it for supply.
(3)The requirements that may be imposed include requirements to—
(a)publish, at the person's expense, one or more warnings, in such form and manner and on such occasions as may be specified in the notice, about a medical device which the person supplies or has supplied;
(b)organise or cooperate with the enforcement authority in organising in such manner as may be specified in the notice, so far as reasonably practicable, the recall of the device to the person or to any other person identified in the notice.
(4)But a requirement to organise or cooperate in the recall of a device may be imposed on a person in reliance on subsection (3)(b) only if the enforcement authority is satisfied that no alternative requirement would sufficiently protect health or safety as mentioned in subsection (1).
(5)A safety notice must set out the grounds on which the enforcement authority considers it necessary to restrict the availability of the medical device to which the notice relates.
(6)The enforcement authority may vary or revoke a safety notice.
(7)Subject to subsection (8), the enforcement authority may not serve a safety notice on a person or vary a safety notice unless the enforcement authority has given the person a reasonable opportunity to make representations about the need for, and the contents of, the proposed safety notice or, as the case may be, proposed variation.
(8)Subsection (7) does not apply where the enforcement authority considers that there is an urgent need to make the proposed safety notice or variation in order to restrict the availability of the medical device to which the proposed safety notice or variation relates.
Commencement Information
I1S. 23 in force at 26.5.2021 by S.I. 2021/610, reg. 2(a)
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.
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.
Text created by the government department responsible for the subject matter of the Act to explain what the Act sets out to achieve and to make the Act accessible to readers who are not legally qualified. Explanatory Notes were introduced in 1999 and accompany all Public Acts except Appropriation, Consolidated Fund, Finance and Consolidation Acts.
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: