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The In Vitro Diagnostic Medical Devices Regulations 2000 (revoked)
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Changes over time for: Paragraph 3
Version Superseded: 13/06/2002
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- 07/06/2000- Amendment
- 07/06/2000
Point in time - 13/06/2002- Amendment
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Point in time view as at 07/06/2000.
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There are currently no known outstanding effects for the The In Vitro Diagnostic Medical Devices Regulations 2000 (revoked), Paragraph 3.
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3. After regulation 12 of the 1994 Regulations (general provisions relating to conformity assessment procedures) there shall be inserted the following regulation—U.K.
“ CE marking of a product which is not a device
12A.—(1) No person shall—
(a)affix the CE marking for a device to a product which is not a device;
(b)place on the market a product which has affixed to it the CE marking for a device if that product is not a device.
(2) No person shall provide information comprising a CE marking for a relevant device on—
(a)a product;
(b)the instructions for use for a product; or
(c)the sales packaging for a product,
if the product is not a device.
(3) No person shall—
(a)supply, offer to supply, or agree to supply a product which has affixed to it a CE marking for a device if—
(i)that supply, offer to supply or agreement to supply a product is also a placing on the market of that product, and
(ii)that product is not a device;
(b)expose or possess for supply a product which has affixed to it a CE marking for a device if—
(i)that exposure for supply or possession for supply of a product is also a placing on the market of that product, and
(ii)that product is not a device.”.
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