The UK Med­i­cines and Health­care Prod­ucts Reg­u­la­to­ry Agency (MHRA) has announced a sig­nif­i­cant change in its approach to charg­ing med­ical device com­pa­nies for post-mar­ket sur­veil­lance (PMS) fees. This revi­sion comes in response to con­cerns raised by small and medi­um-sized enter­pris­es (SMEs) about the ini­tial fee structure.

New fee mod­el implementation

Start­ing from April 1, 2026, the MHRA will imple­ment a new fee mod­el that charges device man­u­fac­tur­ers an annu­al fee based on the num­ber of GMDN lev­el 2 cat­e­gories under which their devices are reg­is­tered. This is a shift from the ini­tial­ly pro­posed lev­el 5 cat­e­gories. Under the new mod­el, com­pa­nies will pay once per lev­el 2 cat­e­go­ry annu­al­ly, regard­less of the num­ber of prod­ucts with­in that category.

Impact on SMEs

The annu­al fee is esti­mat­ed to be around £300 per lev­el 2 cat­e­go­ry. This change is expect­ed to ben­e­fit SMEs, as approx­i­mate­ly 60% of man­u­fac­tur­ers, main­ly those with few­er prod­uct cat­e­gories, will only need to pay a sin­gle charge. This adjust­ment aims to ease the finan­cial bur­den on small­er companies.

Tran­si­tion and cost recovery

The new fee will replace the cur­rent one-off reg­is­tra­tion fee of £261, pro­vid­ing the MHRA with a more pre­dictable income stream. Dur­ing the 2025-26 and 2026-27 finan­cial years, PMS work will be sub­sidised, with full cost recov­ery planned from 2027-28.

Source: Medtech Insight (an Infor­ma product)

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