- Latest available (Revised)
- Point in Time (01/04/2004)
- Original (As made)
The Medical Devices Regulations 2002
You are here:
- UK Statutory Instruments
- 2002 No. 618
- PART I
- Regulation 3
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 3
Version Superseded: 10/03/2007
Alternative versions:
Status:
Point in time view as at 01/04/2004. This version of this provision has been superseded.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 3 is up to date with all changes known to be in force on or before 13 October 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.
Scope of these RegulationsU.K.
3. These Regulations shall not apply to—
(a)medicinal products governed by Directive 2001/83 (including medicinal products derived from human blood or human plasma governed by Title X of Directive 2001/83);
(b)human blood, human blood products, plasma or blood cells of human origin;
(c)devices that incorporate, at the time of placing on the market, human blood, blood products, plasma or blood cells of human origin, except for stable derivatives devices;
(d)transplants or tissues or cells of human origin or products incorporating or derived from tissues or cells of human origin;
(e)transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue;
(f)cosmetic products governed by Council Directive 76/768/EEC M1, as amended M2; or
(g)products whose principal intended purpose is such that they fall under Council Directive 89/686/EEC on the approximation of the laws of the Member States relating to personal protective equipment M3, as amended M4.
Marginal Citations
M1OJ No. L 262, 27.9.1976, p.169.
M2Council Directive 76/768/EEC was amended for the twenty-sixth time by Commission Directive 2000/41/EC (OJ No. L 145, 20.6.2000, p.25).
M3OJ No. L 399, 30.12.1989, p.18.
M4Council Directive 89/686/EEC has been amended by Council Directive 93/68/EEC (OJ No. L 220, 30.8.1993, p.1), Council Directive 93/95/EEC (OJ No. L 276, 9.11.1993, p.11) and Council Directive 96/58/EC (OJ No. L 236, 18.9.1996, p.44).
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.