MDD/AIMDD CE Marked Devices No Longer Accepted in Great Britain

The device must either be MDR CE Marked or UKCA Marked to continue being placed on the Great Britain (England, Scotland, Wales) market after this date. Note that a new registration will be required with the MHRA once the device is transitioned to the MDR CE or UKCA Marking. 

This is noted under UK Statutory Instrument (SI) 2023 No. 627, Regulation 4:

“For regulation 1ZA(1), substitute—

“1ZA.—(1) Subject to paragraph (3), regulations 19B and 30A cease to have effect at 23:59 on 30 June 2028.

(2) Subject to paragraph (3), regulations 19C, 44ZA and 44ZB cease to have effect at 23:59 on 30 June 2030.

(3) The following cease to have effect at 23:59 on 30 June 2023—

(a) regulation 19B(4), (5), (8) and (9);

(b) regulation 19C(8) and (9);

(c) regulation 30A(4) to (7);

(d) regulation 44ZA(4) and (5);

(e) regulation 44ZB(4) and (5).”

IVDD, MDR, and IVDR CE Marked devices have a further two (2) years transition period.

Northern Ireland, the fourth UK country, requires CE Marking and will not recognize UKCA Marking.