The UK med­ical tech­nol­o­gy sec­tor is grap­pling with uncer­tain­ty because the Nation­al Health Service’s (NHS) much-antic­i­pat­ed 10-year health plan has been post­poned until sum­mer. Con­cur­rent­ly, NHS England’s tem­po­rary shut­down has raised ques­tions about the government’s capac­i­ty to over­see device approvals and mar­ket access. Man­u­fac­tur­ers are par­tic­u­lar­ly anx­ious for clar­i­fi­ca­tion on UKCA mark­ing require­ments, whether inter­na­tion­al­ly approved prod­ucts will be accept­ed, and the clas­si­fi­ca­tion of Class B in vit­ro diag­nos­tics.

Con­cerns Over UKCA Mark
For the past three years, indus­try stake­hold­ers have await­ed a new leg­isla­tive frame­work to replace the post-Brex­it pre-mar­ket statu­to­ry instru­ment. Many fear that a UKCA mark holds lit­tle val­ue in a mar­ket that accounts for just 2–3 per­cent of glob­al med­ical tech­nol­o­gy rev­enues. Ear­ly con­sul­ta­tion feed­back sug­gests the Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency may insist that most com­pa­nies retain a CE mark to avoid addi­tion­al UK com­pli­ance. In effect, this would com­pel firms to secure Euro­pean approval mere­ly to sell in Britain.

Mutu­al Recog­ni­tion as a Viable Alter­na­tive
Some experts argue for a sim­pler solu­tion: the UK could nego­ti­ate a mutu­al recog­ni­tion agree­ment with the EU, akin to Turkey’s arrange­ment. Under such a deal, CE-marked devices would be auto­mat­i­cal­ly accept­ed in Great Britain, min­i­miz­ing dupli­ca­tion and align­ing UK rules with EU stan­dards. While this approach would lim­it reliance on approvals from coun­tries like Aus­tralia, Cana­da, or the US, it would grant UK firms pre­dictable access to the broad­er Euro­pean mar­ket.

Source: Medtech Insight (an Infor­ma product)

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