The UK Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) is set to imple­ment new post-mar­ket sur­veil­lance (PMS) reg­u­la­tions for med­ical devices in Great Britain start­ing on June 16, 2025. On Jan­u­ary 15, the MHRA pub­lished guid­ance to assist medtech man­u­fac­tur­ers in under­stand­ing these reg­u­la­tions, which include noti­fi­ca­tion require­ments for inci­dents and actions to be tak­en after a device’s approval. Man­u­fac­tur­ers are encour­aged to famil­iarise them­selves with the guid­ance as soon as possible.

The Med­ical Devices (Post Sur­veil­lance Require­ments) (Amend­ment) Reg­u­la­tions 2024 was pre­sent­ed to the UK Par­lia­ment on Decem­ber 16, 2024 (Statu­to­ry Instru­ment 1368). PMS serves as a cru­cial foun­da­tion­al ele­ment being estab­lished by the MHRA for the upcom­ing reg­u­la­to­ry frame­work for med­ical devices in Great Britain. This will be suc­ceed­ed by a pre-mar­ket statu­to­ry instru­ment, which will be shaped by insights gained from a con­sul­ta­tion that closed on Jan­u­ary 5. Among oth­er top­ics, this con­sul­ta­tion focused on the recog­ni­tion of device approvals grant­ed by reg­u­la­tors in coun­tries with com­pa­ra­ble standards.

The MHRA is focus­ing on a post-mar­ket safe­ty frame­work, assum­ing that approvals from rep­utable over­seas reg­u­la­tors will com­ple­ment UK reg­u­la­tions. This makes PMS cru­cial for safe reg­u­la­tion. New require­ments include enhanced data col­lec­tion, short­er time­lines for report­ing seri­ous inci­dents, and improved sum­ma­ry report­ing to quick­ly iden­ti­fy safe­ty issues. The MHRA out­lines key changes and their impact in a sum­ma­ry table, empha­siz­ing clear­er oblig­a­tions for risk mit­i­ga­tion and com­mu­ni­ca­tion to safe­guard patients and users.

North­ern Ire­land adheres to EU med­ical device reg­u­la­tions for PMS, with notable dif­fer­ences com­pared to Great Britain. These dif­fer­ences include how seri­ous inci­dents are inves­ti­gat­ed and report­ed, the prepa­ra­tion of PMS reports, field safe­ty actions, trend report­ing, and doc­u­men­ta­tion reten­tion. Great Britain is like­ly to iden­ti­fy more poten­tial fail­ures due to broad­er def­i­n­i­tions of ‘inci­dent’ and ‘seri­ous inci­dent’ com­pared to the EU.

Source: Medtech Insight (an Infor­ma product)

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