In Jan­u­ary 2022, the Euro­pean Com­mis­sion has pub­lished five new stan­dards har­monised under Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR) in the Offi­cial Jour­nal of the EU (OJEU). They include the amend­ed EU med­ical devices qual­i­ty man­age­ment sys­tem stan­dard, EN ISO 13485:2016 and four oth­er stan­dards and were pub­lished as har­monised in the con­text of the IVDR. 

Man­u­fac­tur­ers apply­ing these stan­dards may thus pre­sume con­for­mi­ty to the cor­re­spond­ing IVDR gen­er­al safe­ty and per­for­mance requirements. 

The oth­er four lat­est har­monised IVD stan­dards are:

• EN ISO 11737-1:2018 on the ster­il­i­sa­tion of health care products.
• EN ISO 13408-6:2021 on asep­tic pro­cess­ing of health care products.
• EN ISO 15223-1:2021, sym­bols to be used with infor­ma­tion to be sup­plied by the man­u­fac­tur­er; and
• EN ISO 17511:2021, require­ments for estab­lish­ing metro­log­i­cal trace­abil­i­ty of val­ues assigned to cal­i­bra­tors, true­ness con­trol mate­ri­als and human samples. 

It is expect­ed that the amend­ed risk man­age­ment stan­dard, EN ISO 14971:2019 should, be pub­lished in the OJEU in the com­ing months. 

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

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Stan­dard ISO 20417:2021 for the MDR and IVDR published
• IEC about to pub­lish new stan­dard on cybersecurity
• Lat­est ver­sion of ISO 14971 on risk man­age­ment and the MDR and IVDR
• Com­mis­sion to put for­ward anoth­er Euro­pean stan­dards request