The UK Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) is aim­ing to safe­ly intro­duce med­ical device inno­va­tions using new method­olo­gies and data sources. Four com­pa­ra­ble reg­u­la­tor coun­tries (CRC), includ­ing the US Food and Drug Admin­is­tra­tion (FDA), have been select­ed by MHRA for inter­na­tion­al recog­ni­tion of device approvals. Health Cana­da, the Aus­tralian Ther­a­peu­tic Good Admin­is­tra­tion (TGA) and the EU are the oth­er reg­u­la­to­ry sys­tems in the MHRA’s CRC list.

The UK gen­er­al elec­tion some­what dis­rupt­ed the progress of the MHRA’s med­ical device reg­u­la­to­ry sys­tem plans, notably in the case of the post-mar­ket sur­veil­lance (PMS) statu­to­ry instru­ment (SI). The call­ing of the gen­er­al elec­tion the day before the SI had been due to be laid in par­lia­ment thrashed that orig­i­nal sched­ule, but the PMS SI is now due to be laid before the end of 2024. The draft has been pre­sent­ed to the Par­lia­ment in late Octo­ber. PMS is a key enabler for aspects like inter­na­tion­al recognition. 

The UK’s inter­na­tion­al recog­ni­tion frame­work will imple­ment pre­mar­ket con­trols and require all mar­ket prod­ucts to under­go PMS. The sys­tem aims to be effi­cient, quick, and cost-effec­tive, encour­ag­ing trust from oth­er coun­tries based on the UK’s exper­tise. Effec­tive com­mu­ni­ca­tion between the MHRA, Clin­i­cal Research Col­lab­o­ra­tives (CRCs), and EU noti­fied bod­ies is crucial.

The MHRA has reg­is­tered 3.25 mil­lion med­ical devices and aims to pro­vide writ­ten advice with­in 90 days, ide­al­ly 40 days. Key ini­tia­tives include the launch of Safe­ty Con­nect, a respon­sive data­base for report­ing, and an upcom­ing update to the patient involve­ment strat­e­gy. The MHRA also released a data strat­e­gy empha­sis­ing real-world evi­dence and dig­i­tal inno­va­tion, with poten­tial for a frame­work involv­ing pub­lic-pri­vate part­ner­ships for data stor­age and usage.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website