The Euro­pean Com­mis­sion pub­lished on Jan­u­ary 28, 2026, an addi­tion­al amend­ment of Imple­ment­ing Deci­sion (EU) 2021/1182. The amend­ment includes fur­ther har­mo­nized stan­dards that apply under the med­ical devices and IVD med­ical devices reg­u­la­tion (MDR and IVDR).

The fol­low­ing stan­dards have been har­mo­nized under the MDR

EN ISO 7197:2024
Neu­ro­sur­gi­cal implants – Ster­ile, sin­gle-use hydro­cephalus shunts (ISO 7197:2024)
EN ISO 10993-4:2017
Bio­log­i­cal eval­u­a­tion of med­ical devices – Part 4: Selec­tion of tests for inter­ac­tions with blood (ISO 10993-4:2017)
EN ISO 10993-4:2017/A1:2025
EN ISO 14155:2020
Clin­i­cal inves­ti­ga­tion of med­ical devices for human sub­jects – Good clin­i­cal prac­tice (ISO 14155:2020)
EN ISO 14155:2020/A11:2024
EN ISO 14630:2024
Non-active sur­gi­cal implants – Gen­er­al require­ments (ISO 14630:2024)
EN ISO 17665:2024
Ster­il­iza­tion of health care prod­ucts – Moist heat – Require­ments for the devel­op­ment, val­i­da­tion and rou­tine con­trol of a ster­il­iza­tion process for med­ical devices (ISO 17665:2024)
EN ISO 18562-1:2024
Bio­com­pat­i­bil­i­ty eval­u­a­tion of breath­ing gas path­ways in health­care appli­ca­tions – Part 1: Eval­u­a­tion and test­ing with­in a risk man­age­ment process (ISO 18562-1:2024)
EN ISO 18562-2:2024
Bio­com­pat­i­bil­i­ty eval­u­a­tion of breath­ing gas path­ways in health­care appli­ca­tions – Part 2: Tests for emis­sions of par­tic­u­late mat­ter (ISO 18562-2:2024)
EN ISO 18562-3:2024
Bio­com­pat­i­bil­i­ty eval­u­a­tion of breath­ing gas path­ways in health­care appli­ca­tions – Part 3: Tests for emis­sions of volatile organ­ic sub­stances (ISO 18562-3:2024)
EN ISO 18562-4:2024
Bio­com­pat­i­bil­i­ty eval­u­a­tion of breath­ing gas path­ways in health­care appli­ca­tions – Part 4: Tests for leach­ables in con­den­sate (ISO 18562-4:2024)
EN ISO 21535:2024
Non-active sur­gi­cal implants – Joint replace­ment implants – Spe­cif­ic require­ments for hip-joint replace­ment implants (ISO 21535:2023)
EN ISO 21536:2024
Non-active sur­gi­cal implants – Joint replace­ment implants – Spe­cif­ic require­ments for knee-joint replace­ment implants (ISO 21536:2023)
EN ISO 80369-2:2024
Small-bore con­nec­tors for liq­uids and gas­es in health­care appli­ca­tions – Part 2: Con­nec­tors for res­pi­ra­to­ry appli­ca­tions (ISO 80369-2:2024, Cor­rect­ed ver­sion 2025-06)’

The fol­low­ing stan­dards have been har­mo­nized under the MDR

EN ISO 17665:2024
Ster­il­iza­tion of health care prod­ucts – Moist heat – Require­ments for the devel­op­ment, val­i­da­tion and rou­tine con­trol of a ster­il­iza­tion process for med­ical devices (ISO 17665:2024)
EN ISO 18113-1:2024
In vit­ro diag­nos­tic med­ical devices – Infor­ma­tion sup­plied by the man­u­fac­tur­er (labelling) – Part 1: Terms, def­i­n­i­tions, and gen­er­al require­ments (ISO 18113-1:2022)
EN ISO 18113-2:2024
In vit­ro diag­nos­tic med­ical devices – Infor­ma­tion sup­plied by the man­u­fac­tur­er (labelling) – Part 2: In vit­ro diag­nos­tic reagents for pro­fes­sion­al use (ISO 18113-2:2022)
EN ISO 18113-3:2024
In vit­ro diag­nos­tic med­ical devices – Infor­ma­tion sup­plied by the man­u­fac­tur­er (labelling) – Part 3: In vit­ro diag­nos­tic instru­ments for pro­fes­sion­al use (ISO 18113-3:2022)
EN ISO 18113-4:2024
In vit­ro diag­nos­tic med­ical devices – Infor­ma­tion sup­plied by the man­u­fac­tur­er (labelling) – Part 4: In vit­ro diag­nos­tic reagents for self-test­ing (ISO 18113-4:2022)
EN ISO 18113-5:2024
In vit­ro diag­nos­tic med­ical devices – Infor­ma­tion sup­plied by the man­u­fac­tur­er (labelling) – Part 5: In vit­ro diag­nos­tic instru­ments for self-test­ing (ISO 18113-5:2022)’.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website