Har­mon­i­sa­tion of stan­dards under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) is fur­ther pro­gress­ing. The table below shows the stan­dards that have been pub­lished in the Offi­cial Jour­nal of the EU (OJEU) in Jan­u­ary 2022 as giv­ing a ‘pre­sump­tion of con­for­mi­ty’ with the MDR.

For­tu­nate­ly, EN ISO 13485 is includ­ed in the list, but the har­monised ver­sion of the risk man­age­ment stan­dard, EN ISO 14971:2019 with its amend­ment A11:2021 is yet to be pub­lished in the OJEU. 

Stan­dard Ref­er­enceStan­dard Title
EN ISO 10993-92021Bio­log­i­cal eval­u­a­tion of med­ical devices-Part 9: Frame­work for iden­ti­fi­ca­tion and quan­tifi­ca­tion of poten­tial degra­da­tion products
EN ISO 10993-12:2021Bio­log­i­cal eval­u­a­tion of med­ical devices-Part 12: Sam­ple prepa­ra­tion and ref­er­ence materials 
EN ISO 13408-6:2021Asep­tic pro­cess­ing of health care prod­ucts-Part 6: Iso­la­tor systems 
EN ISO 14160:2021Ster­il­i­sa­tion of health care prod­ucts-Liq­uid chem­i­cal ster­il­is­ing agents for sin­gle-use med­ical devices using ani­mal tis­sues and their deriv­a­tives-require­ments for char­ac­ter­i­sa­tion, devel­op­ment, val­i­da­tion and rou­tine con­trol of a ster­il­i­sa­tion process for med­ical devices-Part 1: Gen­er­al requirements 
EN ISO15223-1:2021Med­ical devices-Sym­bols to be used with infor­ma­tion to be sup­plied by the man­u­fac­tur­er-Part 1: Gen­er­al requirements 
EN ISO 17664-1:2021Pro­cess­ing of health care prod­ucts-Infor­ma­tion to be pro­vid­ed by the med­ical device man­u­fac­tur­er for the pro­cess­ing of med­ical devices-Part 1: Crit­i­cal and semi-crit­i­cal med­ical devices
EN ISO 11737-1:2018Ster­il­i­sa­tion of health care prod­ucts-Micro­bi­o­log­i­cal meth­ods-Part 1:Determination of pop­u­la­tion of microor­gan­isms on products 
EN ISO 13485:2016Med­ical devices-Qual­i­ty man­age­ments sys­tems-Require­ments for reg­u­la­to­ry purposes 
EN IEC 60601-2-83:2020Med­ical elec­tri­cal equip­ment-Part 2-83: Par­tic­u­lar require­ments for the basic safe­ty and essen­tial per­for­mance of home light ther­a­py equipment 

The full list of MDR har­monised stan­dards can be accessed here.

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website