New post-mar­ket sur­veil­lance require­ments in Great Britain: Key changes for med­ical device companies

The draft post-mar­ket sur­veil­lance (PMS) require­ments for med­ical devices in Great Britain large­ly align with Euro­pean reg­u­la­tions, but there are notable dif­fer­ences. A new statu­to­ry instru­ment out­lin­ing these require­ments was intro­duced in the British Par­lia­ment in Octo­ber 2024. The draft was “final­ized” on Decem­ber 16, 2024 and thus enters into force on June 16, 2025.

Key Changes in Report­ing Timelines

• Seri­ous Inci­dents: The report­ing dead­line in Great Britain is reduced from 30 days to 15 days.
• Pub­lic Health Threats and Deaths: Report­ing dead­lines remain unchanged at 2 and 10 days, respectively.
• Peri­od­ic Sum­ma­ry Reports (PSRs) and Trend Reports: Require­ments mir­ror those of EU regulations.

Field Safe­ty Cor­rec­tive Actions (FSCAs)

In Great Britain, FSCAs must be report­ed to the MHRA before imple­men­ta­tion, except in emer­gen­cies. Also, British reg­u­la­tions require:

• Noti­fi­ca­tion of the MHRA, includ­ing spe­cif­ic details like the num­ber of devices on the mar­ket and the esti­mat­ed users affected.
• Report­ing of FSCAs from oth­er mar­kets if they involve the same device mod­el sold in Great Britain, even if sim­i­lar actions are not tak­en locally.

Man­u­fac­tur­er Obligations

• The MHRA may request updates and doc­u­ments relat­ed to seri­ous inci­dents, trend reports, or FSCAs. Com­pa­nies must com­ply with­in three work­ing days of a request.

Impact on Compliance

With the new PMS statu­to­ry instru­ment in effect, vig­i­lance require­ments in Great Britain will align more close­ly with EU stan­dards. How­ev­er, the dif­fer­ences neces­si­tate adjust­ments in com­pli­ance strate­gies for med­ical device and in vit­ro diag­nos­tic (IVD) com­pa­nies oper­at­ing in Great Britain.

Source: MHRA

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

Browse by tag “Brex­it”