- Latest available (Revised)
- Point in Time (13/06/2002)
- Original (As made)
Version Superseded: 31/12/2020
Point in time view as at 13/06/2002. This version of this provision has been superseded.
You are viewing this legislation item as it stood at a particular point in time. A later version of this or provision, including subsequent changes and effects, supersedes this version.
Note 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.
The Medical Devices Regulations 2002, Section 50 is up to date with all changes known to be in force on or before 25 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.
50.—(1) No person shall—
(a)affix a notified body or conformity assessment body number to a medical device if that body has not carried out an assessment in respect of that device for that person;
(b)supply a medical device (if that supply is also a placing on the market, or if that supply is of a device which has been placed on the market) which has affixed to it a notified body or conformity assessment body number if that body—
(i)has not carried out an assessment in respect of that device, or has not carried out that assessment for the person responsible for placing the device on the market, or
(ii)has had its designation as a notified body or conformity assessment body withdrawn.
(2) No person shall provide information comprising a notified body or conformity assessment body number on a medical device, the instructions for use for a medical device, or the sales packaging for a medical device if that device—
(a)is being or has been placed on the market; and
(b)the notified body or conformity assessment body—
(i)has not carried out an assessment in respect of that device, or has not carried out that assessment for the person responsible for placing the device on the market, or
(ii)has had its designation as a notified body or conformity assessment body withdrawn.
(3) Where the sectoral annex on medical devices in a Mutual Recognition Agreement under which a conformity assessment body was designated states that the annex does not apply to devices of a particular class or description, no person may supply a medical device of that class or description bearing the number of that conformity assessment body (if that supply is also a placing on the market or putting into service or is of a device that has been placed on the market or put into service) unless—
(a)an assessment has been carried out on that device for the person responsible for placing it on the market or putting it into service by a notified body; and
(b)the device bears the notified body number of that notified body.
(4) For the purposes of this regulation, a notified body shall be taken to have carried out an assessment in respect of a device if it has endorsed a report prepared by a third country conformity assessment body in respect of that device.
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: