The exten­sion of the UK Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency’s  (MHRA) stand­still peri­od for CE-marked devices dis­trib­ut­ing on the Great Britain (GB) mar­ket was declared near the end of April, giv­ing new tran­si­tion dead­lines of more than the one extra year.

The orig­i­nal dead­line of July 1, 2023 was inad­e­quate and the MHRA assured the stand­still peri­od would be extend­ed by one year dur­ing which CE-marked can be used on the GB mar­ket. Indus­try felt that anoth­er year was still inad­e­quate. The leg­isla­tive basis of the UK’s sov­er­eign devices reg­u­la­to­ry sys­tem as an out­come of Brex­it is expect­ed to be formed of three statu­to­ry instru­ments (SIs).

In the MHRA guid­ance on the draft SI pub­lished 27 April, there is no men­tion of 1 July 2024 dead­line and the MHRA says that the gov­ern­ment are aim­ing at hav­ing 1 July 2025 as the dead­line for all the cru­cial fea­tures of the future rule for med­ical devices. 

The draft SI was now recent­ly approved at the end of June where the gov­ern­ment allows for longer tran­si­tion times for the use of CE-marked devices in GB, that is before the oblig­a­tory use of UKCA marked prod­ucts only:

  1. 30 June 2028 (or expiry of cer­tifi­cate, whichev­er is first) for gen­er­al med­i­c­i­nal devices sat­is­fy­ing the EU Med­ical Devices Direc­tive (MDD) or Active Implantable Med­ical Devices Direc­tive (AIMDD).
  2. 30 June 2030 for in vit­ro diag­nos­tic med­ical devices com­pli­ant with the In Vit­ro Diag­nos­tic Direc­tive (IVDD).
  3. 30 June 2030 for gen­er­al med­ical devices, includ­ing cus­tom-made devices, com­pli­ant with the MDR and IVDs com­pli­ant with the IVDR.

Fur­ther guid­ance was pub­lished on device registrations:

Expired CE cer­tifi­cates: Require­ment to upload a let­ter declar­ing com­pli­ance with extend­ed valid­i­ty under the MDR;

Up-clas­si­fied class I devices: Require­ment to mon­i­tor the MHRA web­site for updates. Cur­rent MHRA reg­is­tra­tion will need to be updat­ed by June 2028.

Source: Medtech Insight (an Infor­ma product)

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