The Euro­pean Com­mis­sion has issued a doc­u­ment that is high­ly rel­e­vant for man­u­fac­tur­ers of reusable and rester­il­iz­able med­ical devices.

You can find this doc­u­ment here.

The back­ground for issu­ing this doc­u­ment are defi­cien­cies in the doc­u­men­ta­tion of many prod­ucts belong­ing to this device group. Although class I and IIa med­ical devices may be placed on the mar­ket in Europe with­out IFU, numer­ous man­u­fac­tur­ers make inap­pro­pri­ate use of this option.

The med­ical devices direc­tive (MDD) essen­tial require­ments require the IFU to include infor­ma­tion relat­ed to the device reuse (e.g. clean­ing, dis­in­fec­tion, ster­il­iza­tion). The described meth­ods must be prop­er­ly val­i­dat­ed. Ref­er­ence stan­dards are EN ISO 17644 and EN 14937. 

The check­list that has now been pub­lished is intend­ed to bring more clar­i­ty on what can be expect­ed of man­u­fac­tur­ers in terms of IFU con­tents and the cor­re­spond­ing val­i­da­tion. This point is high­ly rel­e­vant because it can be expect­ed that com­pe­tent author­i­ties will have a clos­er eye on prod­ucts like reusable sur­gi­cal instru­ments in the extend­ed tran­si­tion peri­od until May 25, 2024.

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

To receive fur­ther infor­ma­tion on this sub­ject, please notice the fol­low­ing con­tent on our website