Follow-up: Regu­la­ti­on to extend dead­line for MDR/IVDR com­pli­ance adopted!

As expec­ted, the Coun­cil of the Euro­pean Uni­on adopted the Com­mis­si­on’s pro­po­sal for a regu­la­ti­on amen­ding the MDR and IVDR on 7 March 2023. Lon­ger tran­si­ti­on peri­ods for the adapt­a­ti­on of medi­cal devices and IVDs to the requi­re­ments of MDR and IVDR are the­r­e­fo­re beco­ming a reality! 

Dif­fe­rent tran­si­ti­on peri­ods will app­ly to medi­cal devices of dif­fe­rent risk classes.

Requi­re­ments for an exten­si­on of time limits and “hid­den” time limits

Howe­ver, not all pro­ducts will bene­fit equal­ly from the lon­ger tran­si­ti­on peri­ods. The pro­po­sed regu­la­ti­on links the pos­si­bi­li­ty of not having to make pro­ducts MDR-compliant until after the respec­ti­ve tran­si­ti­on peri­ods have expi­red to fur­ther strict con­di­ti­ons. Health Com­mis­sio­ner Stel­la Kyria­ki­des empha­sis­ed: “It is important to note that this addi­tio­nal time can only be used for medi­cal devices that are safe and for which manu­fac­tu­r­ers have alre­a­dy taken steps to tran­si­ti­on to the Medi­cal Device Regu­la­ti­on. Pati­ent safe­ty will always come first.”

Regard­less of the sta­tus of a Noti­fied Body cer­ti­fi­ca­te available for the pro­ducts, clai­ming an exten­si­on always requi­res that the pro­ducts in question:

  • con­ti­nue to be com­pli­ant with the requi­re­ments of the Direc­ti­ves (MDD, AIMD, IVDD);
  • have not been signi­fi­cant­ly chan­ged and no chan­ge has been made to their inten­ded purpose;
  • do not pose a safe­ty risk or have the poten­ti­al to pose a hazard.

In addi­ti­on, the manu­fac­tu­rer must imple­ment a qua­li­ty manage­ment sys­tem that meets the requi­re­ments of the MDR and IVDR no later than 26 May 2024. For devices belon­ging to a hig­her risk class than Class I, clo­se coope­ra­ti­on of the manu­fac­tu­rer with a Noti­fied Body must also alre­a­dy exist or be initia­ted in a time­ly man­ner, aiming at a joint con­for­mi­ty assess­ment accor­ding to the requi­re­ments of the MDR. 26 May 2024 and 26 Sep­tem­ber 2024 are the dead­lines for appli­ca­ti­on pro­ce­du­res and con­trac­ting with Noti­fied Bodies.

Recom­men­da­ti­on for action by manufacturers

In order to bene­fit from the dead­line exten­si­on, manu­fac­tu­r­ers must veri­fy that their pro­duct falls within the scope of the Regu­la­ti­on and that the con­di­ti­ons for a dead­line exten­si­on are met. For more infor­ma­ti­on and a check­list show­ing pos­si­ble ways to extend the dead­line, see our one pager entit­led “MDR dead­line exten­si­on check­list”.

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