Peri­od­ic Safe­ty Update Reports (PSURs) are an impor­tant ele­ment of the EU’s Reg­u­la­tion 2017/745 on med­ical devices (MDR). A recent­ly issued com­pre­hen­sive guid­ance doc­u­ment, MDCG 2022-21, aims at help­ing man­u­fac­tur­ers to under­stand these requirements.

It con­tains five main sec­tions and comes with numer­ous sub­sec­tions and five annex­es, includ­ing a tem­plate for the PSUR, and a web form:

  1. Intro­duc­tion
  2. Gen­er­al considerations
  3. Scope and dura­tion of the PSUR requirement
  4. Group­ing of devices
  5. PSUR prepa­ra­tion and issuance

MDR’s arti­cle 86 oblig­es man­u­fac­tur­ers of class III, class IIb and class IIa devices to pre­pare a PSUR for each device and where applic­a­ble, for each cat­e­go­ry or group of devices.

PSURs must be pre­pared for:

MDR com­pli­ant devices
Class IIa, class IIb and class III devices cer­ti­fied in line with the require­ments of the MDR placed on the mar­ket or put into oper­a­tion before or after the 26 May 2021 MDR date of application
Cus­tom-made devices falling with­in class IIa, class IIb and class III in agree­ment with the require­ments of the MDR
Annex XVI devices falling with­in class IIa, class IIb and class III devices, once the MDR becomes applic­a­ble to those devices
Lega­cy devices
All lega­cy devices 

Class I MDR devices, class I lega­cy devices and old devices (devices for which no indi­vid­ual devices have been placed on the mar­ket since 26 May 2021) are not com­pelled to meet the requirements.

The guid­ance fur­ther explains that the chief aim of a PSUR is to give a sum­ma­ry of the results and deduc­tions of the analy­sis of post-mar­ket sur­veil­lance (PMS) data relat­ing to a device or a device group. This facil­i­tates report­ing on any pos­si­ble changes to the ben­e­fit-risk pro­file of the med­ical device(s), con­sid­er­ing new or emerg­ing infor­ma­tion in the con­text of cumu­la­tive infor­ma­tion on ben­e­fits and risks. 

The PSUR should sum up the results and deduc­tions of the analy­sis of the data which the man­u­fac­tur­er has method­i­cal­ly and active­ly col­lect­ed in PMS with its device(s) and, where appro­pri­ate, with sim­i­lar devices.

Con­fu­sion seem­ing­ly remains around the top­ic of the device life­time and calls have been heard for a clear, organ­ised pre­sen­ta­tion instead of a such a lengthy guid­ance for an already com­pre­hen­sive and exten­sive regulation.

Source: Medtech Insight (an Infor­ma prod­uct), MDCG

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website