Hi
We have submitted this statement to our UKCA NB. Note this is for IVD's.
have been and are in conformity with the essential requirements and provisions of Part IV of the Medical Devices Regulations 2002 (SI 618) as subsequently amended by the UK exit regulations of 2019 (SI 791) and 2020 (SI 1478) for in–vitro diagnostic medical devices for IVD’s which are for self-testing and are in conformity with the national standards transposing harmonised standards EN13532:2002, EN13612:2002, ISO 23640:2015, EN13975:2003, EN 13641: 2002, EN ISO 14971:2012, EN ISO 15223:2016, and EN ISO 13485:2016.
and are subject to the procedure set out in PART V (Notified Bodies, Conformity Assessment Bodies and Marking of Products) of the UK MDR 2002
under the supervision of Notified Body Number 0086,
BSI Assurance UK Ltd
Kitemark Court Davy Avenue Knowlhill,
Milton Keynes, MK5 8PP,
United Kingdom
It is not yet approved but I know it has been scrutinised by them some time ago and no comment has been made.
Hope this helps