MHRA con­sul­ta­tion on med­ical device fees

In mid August, the Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) ini­ti­at­ed a con­sul­ta­tion on a fee increase for med­ical device registrations. 

Pre­vi­ous­ly in spring this year, the statu­to­ry fee was already restruc­tured – it is thus cur­rent­ly based on GMDN code cat­e­gories. Charges are GBP 300 per annum per Lev­el 2 cat­e­go­ry. The con­sul­ta­tion now pro­pos­es an increase to GBP 511 per Lev­el 2 cat­e­go­ry as of April 1, 2027.

The com­plete doc­u­ment can be accessed here.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• MHRA opens con­sul­ta­tion on the future of CE mark­ing in Great Britain
• MHRA revis­es post-mar­ket sur­veil­lance fees for med­ical device companies