Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) requires man­u­fac­tur­ers to ful­fill much more spe­cif­ic oblig­a­tions with regards to usability. 

It is impor­tant to note that these require­ments are applic­a­ble for all types of med­ical devices.

For exam­ple, annex I (3) requires the man­u­fac­tur­er to have a risk man­age­ment sys­tem in place that “estimate[s] and evaluate[s] the risks asso­ci­at­ed with, and occur­ring dur­ing, the intend­ed use and dur­ing rea­son­ably fore­see­able mis­use;” 

Annex I (5) then requires man­u­fac­tur­ers to reduce risks relat­ed to use error by

“a) reduc[ing] as far as pos­si­ble the risks relat­ed to the ergonom­ic fea­tures of the device and the envi­ron­ment in which the device is intend­ed to be used (design for patient safe­ty), and 

(b) giv[ing] con­sid­er­a­tion to the tech­ni­cal knowl­edge, expe­ri­ence, edu­ca­tion, train­ing and use envi­ron­ment, where applic­a­ble, and the med­ical and phys­i­cal con­di­tions of intend­ed users (design for lay, pro­fes­sion­al, dis­abled or oth­er users).”

There are more aspects that should be con­sid­ered in this con­text. As such, man­u­fac­tur­ers must also include usabil­i­ty con­sid­er­a­tions in their PMS activities. 

Please fol­low IEC 62366-1

The bot­tom line is to make use of avail­able stan­dards. Although no stan­dards have been har­mo­nized yet under the MDR, man­u­fac­tur­ers are best advised to fol­low IEC 62366-1 because this rep­re­sents the cur­rent state-of-the-art. 

As always, should you have any ques­tions or con­cerns, please don’t hes­i­tate to get in touch!

Source: MDR

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