The Depart­ment of Health and Social Care (DHSC) and UK Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) plan to have fur­nished inter­na­tion­al recog­ni­tion for med­ical devices used in Great Britain. 

MHRA agreed that the UK’s tran­si­tion from EU mem­ber state to a coun­try with a stand­alone sov­er­eign med­ical device reg­u­la­to­ry sys­tem has made it clear the sig­nif­i­cance of work­ing in coop­er­a­tion with oth­er reg­u­la­tors nation­wide and world­wide. The UK is at a cru­cial moment in its evo­lu­tion as it pur­sues faster, risk-pro­por­tion­ate and more pre­dictable reg­u­la­to­ry path­ways for the UK. 

Hence, the agency will insti­tute numer­ous new pri­or­i­ty reg­u­la­to­ry path­ways for new med­ical prod­ucts for diag­nos­tics and genomics, data sci­ence, arti­fi­cial intel­li­gence (AI) and soft­ware as a med­ical device, vac­cines and immunother­a­pies and bio­ther­a­peu­tics, cell and gene therapies.

Gen­er­al­ly, the inten­tion is that by 31 March 2025, Great Britain will have approved new recog­ni­tion path­ways for the UK device autho­ri­sa­tion that will enhance exist­ing nation­al UK routes to mar­ket.  

Source: Medtech Insight (an Infor­ma product)

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