PART IIGeneral Medical Devices

F5UK marking of general medical devicesE210

1

Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device or its sterile pack bears a F13UK marking which—

a

meets the requirements set out in F14Annex 2 of Regulation (EC) No 765/2008;

b

is in a visible, legible and indelible form; and

c

is accompanied by any relevant F7approved body or conformity assessment body identification number for that device.

2

Subject to regulations 12 and 14, no person shall supply a relevant device unless, where practical and appropriate, that device or its sterile pack bears a F15UK marking which—

a

meets the requirements set out in F12Annex 2 of Regulation (EC) No 765/2008;

b

is in a visible, legible and indelible form; and

c

is accompanied by any relevant F3approved 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 regulations 12 and 14, no person shall place on the market or put into service a relevant device unless F8a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008, appears on—

a

any sales packaging for that device; and

b

the instructions for use for the device,

and that F11UK marking is accompanied by any relevant F4approved body or conformity assessment body identification number for that device.

4

Subject to regulations 12 and 14, 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 F2a UK marking meeting the requirements of Annex 2 of Regulation (EC) No 765/2008, appears on—

a

any sales packaging for that device; and

b

the instructions for use for the device,

and that F6UK marking is accompanied by any relevant F1approved body or conformity assessment body identification number for that device.

5

No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

a

a relevant device or its sterile pack;

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 F9UK marking or which reduces the visibility or the legibility of the F9UK marking.

F106

In this regulation, where a device is required to bear a UK marking which meets the requirements of Annex 2 of Regulation (EU) No 765/2008, the requirement as to the minimum size of the UK marking specified in section 3 of that Annex is to be understood—

a

as not applying where, having regard to the small size of the device, it is not possible for the device to bear a marking of that minimum size; and

b

as allowing a device to bear a UK marking of a size less than that minimum size provided that mark continues to meet the requirements as to visibility, legibility and indelibility in paragraphs (1) and (2).

CE marking of general medical devicesE110

1

Subject to regulations 12 and 14, no person shall place on the market or put into service a relevant device unless, where practical and appropriate, that device or its sterile pack bears a CE marking which—

a

meets the requirements set out in Annex XII;

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 regulations 12 and 14, no person shall supply a relevant device unless, where practical and appropriate, that device or its sterile pack bears a CE marking which—

a

meets the requirements set out in Annex XII;

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 regulations 12 and 14, 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 XII, appears on—

a

any sales packaging for that device; and

b

the instructions for use for the device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

4

Subject to regulations 12 and 14, 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 XII, appears on—

a

any sales packaging for that device; and

b

the instructions for use for the device,

and that CE marking is accompanied by any relevant notified body or conformity assessment body identification number for that device.

5

No person shall affix any mark or inscription to, or provide any information comprising a mark or inscription on—

a

a relevant device or its sterile pack;

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.