Reg­u­la­tion (EU) 2023/607, which gives man­u­fac­tur­ers more time for the cer­ti­fi­ca­tion of cer­tain med­ical devices under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) will be reflect­ed in updat­ed guid­ance from the UK Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA), so that there will be no scarci­ty of med­ical devices on the market.

Like in the EU, in the UK exten­sion of the tran­si­tion peri­od for class III and cer­tain class IIb implantable devices (like pace­mak­ers) will lead to a new lega­cy prod­ucts dead­line of 31 Decem­ber 2027. The tran­si­tion peri­od for oth­er class IIb devices, class IIa, class Im, Is and cer­tain class I devices (e.g. reusable sur­gi­cal instru­ments) will be extend­ed to 31 Decem­ber 2028. 

The move will mean that Euro­pean man­u­fac­tur­ers can con­tin­ue to pro­vide the UK mar­ket with med­ical prod­ucts with­out requir­ing an excep­tion­al use autho­ri­sa­tion. No exact tim­ings were divulged for the upcom­ing statu­to­ry instru­ments yet.

Source: Medtech Insight (an Infor­ma product)

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