More stan­dards under MDR and IVDR harmonized

On April 8, 2025, the Euro­pean Com­mis­sion pub­lished in the Offi­cial jour­nal of the EU, addi­tion­al har­mo­nized stan­dards under the Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices or in vit­ro diag­nos­tic med­ical devices respec­tive­ly (MDR and IVDR).

Under the MDR, EN 455-1 and 455-2 on med­ical gloves have been pub­lished. Fur­ther­more, two stan­dards for the ster­il­iza­tion of med­ical devices (EN 556-1 and EN 556-2) and for patient han­dling equip­ment in ambu­lances (EN 1865-2 and EN 1865-6) were harmonized.

Under the IVDR, only EN 556-1 and EN 556-2 were harmonized.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• The EU’s stan­dard­i­s­a­tion guid­ance MDCG 2021-5 has been updated
• Euro­pean har­monised stan­dards to be with­out charge
• Har­mo­niza­tion of MDR and IVDR stan­dards still slow