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:

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)

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