The Euro­pean Com­mis­sion has pub­lished its lat­est update to the har­monised stan­dards list, cov­er­ing steam ster­il­iz­ers, stain­less steel steam boil­ers, and hear­ing aids. Man­u­fac­tur­ers in these prod­uct areas should review their tech­ni­cal doc­u­men­ta­tion with­out delay.

How har­monised stan­dards work under the MDR

Under Reg­u­la­tion (EU) 2017/745 (MDR), con­for­mi­ty with a har­monised stan­dard whose ref­er­ence has been pub­lished in the Offi­cial Jour­nal of the Euro­pean Union (OJEU) con­fers a pre­sump­tion of con­for­mi­ty with the Gen­er­al Safe­ty and Per­for­mance Require­ments (GSPRs) cov­ered by that stan­dard. While their use is vol­un­tary, align­ment with har­monised stan­dards is wide­ly regard­ed as the most effi­cient route to demon­strat­ing reg­u­la­to­ry com­pli­ance, and is rou­tine­ly expect­ed by Noti­fied Bod­ies dur­ing con­for­mi­ty assessment.

What has been added

Com­mis­sion Imple­ment­ing Deci­sion (EU) 2026/760 of 1 April 2026, pub­lished in the OJEU, amends the MDR har­monised stan­dards list by adding ref­er­ences cov­er­ing three sub­ject areas: 

EN 13060:2025
Ster­il­iz­ers for med­ical pur­pos­es – Small steam ster­il­iz­ers – Require­ments and testing
EN 14222:2021+A1:2025
Stain­less steel steam boilers
EN IEC 60118-0:2024
Elec­troa­coustics – Hear­ing aids – Part 0: Mea­sure­ment of the per­for­mance char­ac­ter­is­tics of hear­ing aids’

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website