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The Medical Devices Regulations 2002
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Rhagor o Adnoddau
Changes over time for: Section 36
Version Superseded: 31/12/2020
Alternative versions:
- 13/06/2002- Amendment
- 01/04/2009
Point in time - 31/12/2020- Amendment
- 11/08/2021- Amendment
Status:
Point in time view as at 01/04/2009. This version of this provision has been superseded.
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CE marking ofin vitro diagnostic medical devicesU.K.
36.—(1) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device bears a CE marking which—
(a)meets the requirements set out in Annex X;
(b)is in a visible, legible and indelible form; and
(c)is accompanied by any relevant notified body or conformity assessment body identification number for that device.
(2) Subject to regulation 39, no person shall supply a relevant device unless, where practical and appropriate, that device bears a CE marking which—
(a)meets the requirements set out in Annex X;
(b)is in a visible, legible and indelible form; and
(c)is accompanied by any relevant notified body or conformity assessment body identification number for that device,
if that supply is also a placing on the market or putting into service or if that supply is of a device that has been placed on the market or put into service.
(3) Subject to regulation 39, no person shall place on the market or put into service a relevant device unless a CE marking, meeting the requirements set out in Annex X, appears on—
(a)any sales packaging for that device; and
(b)the instructions for use for that device,
and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.
(4) Subject to regulation 39, no person shall supply a relevant device (if that supply is also a placing on the market or putting into service, or if that supply is of a device that has been placed on the market or put into service) unless a CE marking, meeting the requirements set out in Annex X, appears on—
(a)any sales packaging for that device; and
(b)the instructions for use for that device,
and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.
(5) Subject to regulation 39, no person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—
(a)a relevant device;
(b)the instructions for use for a relevant device; or
(c)any sales packaging for a relevant device,
which is likely to mislead a third party with regard to the meaning or the graphics of the CE marking or which reduces the visibility or the legibility of the CE marking.
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