On April 2025, the UK Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) planned to roll out most of its new­ly pro­posed fee increas­es, includ­ing a gen­er­al 8.85% boost across all statu­to­ry fees. How­ev­er, the much-dis­cussed new reg­is­tra­tion fee of £210 per GMDN code for med­ical devices has been post­poned for fur­ther review. Dur­ing an eight-week con­sul­ta­tion in autumn 2024, 72% of par­tic­i­pants expressed their oppo­si­tion to the new reg­is­tra­tion charge. Crit­ics, includ­ing the Asso­ci­a­tion of British HealthTech Indus­tries (ABHI), argue that these changes place an undue bur­den on com­pa­nies — espe­cial­ly those with mul­ti­ple prod­uct codes like IVD man­u­fac­tur­ers, sur­gi­cal instru­ment mak­ers, and wound care suppliers.

Con­cerns have also been raised about ris­ing fees for clin­i­cal inves­ti­ga­tions, prompt­ing the MHRA to let small and medi­um enter­pris­es split tri­al costs into two pay­ments. Addi­tion­al­ly, new fees for approved body des­ig­na­tions faced sim­i­lar dis­ap­proval. In par­al­lel, over half of the respon­dents backed a new MHRA ser­vice offer­ing reg­u­la­to­ry advice meet­ings for an hourly fee of £987, designed to help com­pa­nies nav­i­gate the updat­ed frame­work. The agency insists these steps are nec­es­sary to main­tain a robust reg­u­la­to­ry sys­tem, though many in the indus­try wor­ry about the poten­tial impact on inno­va­tion and invest­ment in the UK.

Source: Medtech Insight (an Infor­ma product)

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