The Euro­pean Com­mis­sion has pub­lished a new imple­ment­ing reg­u­la­tion (EU) 2021/2026 out­lin­ing rules con­cern­ing the use of elec­tron­ic instruc­tions for use (elFU) in the con­text of Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR). It took effect from 3 Jan­u­ary 2022 and replaces ear­li­er elFU rules (EU) 207/2012 agreed to in the con­text of the for­mer med­ical device directives.

Under the new imple­ment­ing reg­u­la­tion, man­u­fac­tur­ers can offer eIFUs in place of instruc­tions in paper form for the fol­low­ing devices under the MDR:

  1. Implantable and active implantable med­ical devices and their accessories;
  2. Fixed instal­la­tion med­ical devices and their acces­sories; and
  3. Med­ical devices and their acces­sories equipped with a built-in sys­tem visu­al­ly show­ing the IFU.

The new text also clar­i­fies how a risk assess­ment should be organ­ised and kept updat­ed so that it safe to pro­vide IFU elec­tron­i­cal­ly. There should be a review of:

  1. Char­ac­ter­is­tics of the envi­ron­ment in which the device will be used;
  2. Pre­dictable med­ical emer­gency cir­cum­stances neces­si­tat­ing the sup­ply of infor­ma­tion in paper form; and
  3. Per­for­mance of safe­ty mea­sures to guar­an­tee that the elec­tron­ic data and con­tent are safe­guard­ed from manipulation.

It also explains fur­ther con­sid­er­a­tions a man­u­fac­tur­er should make to pro­vide eIFU’s. For exam­ple, any web­site includ­ing eIFUs must be pro­tect­ed against illic­it access and inter­fer­ing of data and set up so that the serv­er down­time and dis­play faults are con­sid­er­ably lessened. 

This new imple­ment­ing reg­u­la­tion will apply under the MDR where­as the pre­vi­ous rules are still valid for lega­cy devices.

Source: Medtech Insight (an Infor­ma prod­uct), Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website