The UK Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) dis­closed its draft pol­i­cy for UK recog­ni­tion of inter­na­tion­al reg­u­la­tors’ approvals of med­ical devices ear­li­er in May this year. This pol­i­cy will be applic­a­ble in Great Britain, with full exe­cu­tion expect­ed by 2025. The UK MHRA has pro­posed using approvals from third coun­tries and Med­ical Device Sin­gle Audit Pro­gramme (MDSAP) certificates. 

These routes will be sup­ple­men­tary to the UKCA mark­ing process and the cur­rent tran­si­tion­al recog­ni­tion of devices with CE marks issued under EU device reg­u­la­tions will con­tin­ue until at least 30 June 2030.

UK reg­u­la­tions sched­uled for mid-2025 will encom­pass inter­na­tion­al recog­ni­tion and reliance. The UK reg­u­la­tor has estab­lished a frame­work called Com­pa­ra­ble Reg­u­la­tor Coun­tries (CRCs) to lever­age the exper­tise and deci­sion-mak­ing of oth­er glob­al reg­u­la­tors. It would have the author­i­ty to deny appli­ca­tions if the evi­dence pro­vid­ed is deemed insuf­fi­cient­ly robust.

The MHRA has select­ed the fol­low­ing device reg­u­la­to­ry juris­dic­tions as CRCs:

The pro­posed frame­work would estab­lish a cer­tifi­cate of inter­na­tion­al recog­ni­tion, enabling devices to gain access to the Great Britain mar­ket, although it would not pro­vide UKCA cer­ti­fi­ca­tion. Reliance on the work of oth­er reg­u­la­tors is seen as a more effec­tive form of reg­u­la­to­ry over­sight, accord­ing to the MHRA. This approach would lead to more pre­dictable and faster approvals, improv­ing patient access to high-qual­i­ty med­ical devices. Addi­tion­al­ly, reduc­ing dupli­ca­tion of file assess­ments will enable the MHRA to direct more atten­tion towards inno­v­a­tive prod­ucts, ben­e­fit­ing man­u­fac­tur­ers in resource allocation.

Man­u­fac­tur­ers must sub­mit a dossier to MHRA in the rel­e­vant CRC for­mat or the Inter­na­tion­al Med­ical Device Reg­u­la­tors Forum (IMDRF) table of con­tents for­mat. Full dossiers will not be reviewed by the MHRA but may be assessed if required. Evi­dence of approval and a post-mar­ket sur­veil­lance (PMS) plan asso­ci­at­ed PMS report, or peri­od­ic safe­ty update report (PSUR) will be eval­u­at­ed. Com­pa­nies must also have a UK-respon­si­ble per­son, whose name will be includ­ed on the label via over-labelling or, in the future, dig­i­tal labelling. The frame­work will not be applic­a­ble in North­ern Ire­land, which is gov­erned by the EU MDR and IVDR.

Source: Medtech Insight (an Infor­ma product)

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