- Latest available (Revised)
- Point in Time (13/06/2002)
- Original (As made)
The Medical Devices Regulations 2002
You are here:
- UK Statutory Instruments
- 2002 No. 618
- PART II
- Regulation 19
What Version
Advanced Features
- Show Geographical Extent(e.g. England, Wales, Scotland and Northern Ireland)
- Show Timeline of Changes
More Resources
Changes over time for: Section 19
Version Superseded: 21/03/2010
Alternative versions:
Status:
Point in time view as at 13/06/2002. This version of this provision has been superseded.
Status
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.
Changes to legislation:
The Medical Devices Regulations 2002, Section 19 is up to date with all changes known to be in force on or before 29 April 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 to Legislation
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.
Registration of persons placing general medical devices on the marketU.K.
19.—(1) Subject to paragraph (6), for the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person to whom this paragraph applies shall—
(a)inform the Secretary of State of the address of his registered place of business; and
(b)supply the Secretary of State with a description of each category of device concerned.
(2) Paragraph (1) applies to—
(a)a manufacturer with a registered place of business in the United Kingdom who, under his own name, places on the market in the United Kingdom a relevant device which is a Class 1 device or a custom-made device, other than a system or procedure pack which is not CE marked; and
(b)a person with a registered place of business in the United Kingdom who sterilises before use relevant devices designed by their manufacturer to be sterilised before use.
(3) Subject to paragraph (6), for the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person with a registered place of business in the United Kingdom who places a device mentioned in paragraph (2) on the market in the United Kingdom on behalf of a manufacturer who does not have a registered place of business in the Community or in a State which is a Party to an Association Agreement shall inform the Secretary of State of—
(a)the address of his registered place of business;
(b)the category of device; and
(c)in the case of an authorised representative of the manufacturer, the fact that he is the manufacturer’s authorised representative, and he shall furnish the Secretary of State with sufficient evidence that he is an authorised representative of the manufacturer.
(4) Subject to paragraph (6), for the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person with a registered place of business in the United Kingdom who places a system or procedure pack which is not CE marked on the market in the United Kingdom, or who sterilises systems or procedure packs before they are placed on the market, shall—
(a)inform the Secretary of State of the address of that registered place of business; and
(b)supply the Secretary of State with descriptions of the devices which are included in any such system or procedure pack in a manner sufficient to identify them.
(5) Subject to paragraph (6), for the purpose of enabling the Secretary of State to exercise his functions under these Regulations, any person with a registered place of business in the United Kingdom who places a relevant device which is a Class IIb or III device on the market in the United Kingdom (including the authorised representative of a manufacturer of a Class IIb or III device who does not have a registered place of business in the Community or in a State which is a Party to an Association Agreement) shall, if the Secretary of State so requests, supply the Secretary of State with all data allowing for the identification of the device together with the label and the instructions for use for when the device is put into service within the United Kingdom.
(6) Registration under this regulation is not required if—
(a)the device or pack was first placed on the market in a State which is a Party to an Association Agreement (if that Agreement contains measures relating to the mutual recognition of the results of conformity assessment undertaken in respect of that device); and
(b)the manufacturer or his authorised representative has already registered with the competent authorities of that State.
Options/Help
Print Options
PrintThe Whole Instrument
PrintThe Whole Part
PrintThis Section only
Legislation is available in different versions:
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.
See additional information alongside the content
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.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as enacted version that was used for the print copy
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
Timeline of Changes
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.
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as made version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.