Com­pli­ance with the IVDR now! The IVDR takes effect as of 26 May 2022: keep in mind tran­si­tio­nal periods!

Regu­la­ti­on (EU) 2017/746 on in-vitro dia­gno­stics (the IVDR) has been in effect sin­ce 26 May 2022, repla­cing Direc­ti­ve 98/79/EC on in-vitro dia­gno­stics (the IVDD). As of this date, in-vitro dia­gno­stics are requi­red to com­ply with the IVDR. For a lar­ge num­ber of in-vitro dia­gno­stics, this means the inclu­si­on of a noti­fied body in the con­for­mi­ty assess­ment pro­ce­du­re (link to the Janu­ary news­let­ter: “Grace Peri­od for IVDR Com­pli­ance”). Given the small num­ber of noti­fied bodies which have been accre­di­ted in accordance with the IVDR, the inclu­si­on of noti­fied bodies poses a chall­enge for manu­fac­tu­r­ers of in-vitro dia­gno­stics. This cir­cum­s­tance has been unders­tood by Euro­pean law­ma­kers after hea­ring clear mes­sa­ges from the indus­try, and manu­fac­tu­r­ers of in-vitro dia­gno­stics who­se con­for­mi­ty assess­ment pro­ce­du­res are to include a noti­fied body in accordance with the IVDR have been gran­ted exten­ded tran­si­tio­nal peri­ods for com­pli­ance with the IVDR.

Tran­si­tio­nal peri­ods for com­pli­ance with the IVDR based on the risk class of the in-vitro diagnostics

The length of the­se tran­si­tio­nal peri­ods depends on the risk class of the in-vitro dia­gno­stics. Manu­fac­tu­r­ers of in-vitro dia­gno­stics can only bene­fit from the­se tran­si­tio­nal peri­ods if their pro­ducts meet the spe­ci­fi­ca­ti­ons of the IVDD and if no signi­fi­cant chan­ges are made after 26 May 2022 to the device its­elf or to its inten­ded purpose.

Expi­ra­ti­on of the tran­si­tio­nal peri­ods will mean that in-vitro dia­gno­stics will be requi­red to com­ply in full with the IVDR as of the fol­lo­wing dates:

  • For Class A in-vitro dia­gno­stics (non-sterile) and in-vitro dia­gno­stics of all clas­ses who­se decla­ra­ti­on of con­for­mi­ty is issued after 26 May 2022, the effec­ti­ve date for com­pli­ance with the IVDR is 26 May 2022.
  • For Class D in-vitro dia­gno­stics, the effec­ti­ve date for com­pli­ance with the IVDR is 26 May 2025, pro­vi­ded their decla­ra­ti­on of con­for­mi­ty was issued pri­or to 26 May 2022.
  • For Class C  in-vitro dia­gno­stics, the effec­ti­ve date for com­pli­ance with the IVDR is 26 May 2026, pro­vi­ded their decla­ra­ti­on of con­for­mi­ty was issued pri­or to 26 May 2022.
  • For Class B and Class A (ste­ri­le) in-vitro dia­gno­stics, the effec­ti­ve date for com­pli­ance with the IVDR is 26 May 2027, pro­vi­ded their decla­ra­ti­on of con­for­mi­ty was issued pri­or to 26 May 2022.

In-vitro dia­gno­stics which are pla­ced on the mar­ket pri­or to their effec­ti­ve date for com­pli­ance with the IVDR may be made available on the mar­ket for one addi­tio­nal year after the pas­sa­ge of their effec­ti­ve date (the “sell-off rule”), with “making available on the mar­ket” defi­ned as any sup­p­ly of a device for dis­tri­bu­ti­on, con­sump­ti­on or use on the Uni­on mar­ket in the cour­se of a com­mer­cial acti­vi­ty, whe­ther in return for pay­ment or free of char­ge. This means e.g. that devices which are pla­ced on the mar­ket, i.e. which were made available in the Uni­on mar­ket for the first time, pri­or to the device­’s effec­ti­ve date for com­pli­ance with the IVDR may con­ti­nue to be sold for one addi­tio­nal year after the effec­ti­ve date specified.

Manu­fac­tu­r­ers of in-vitro dia­gno­stics which are pla­ced on the mar­ket after their effec­ti­ve date for com­pli­ance with the IVDR are requi­red to ensu­re that their devices meet the requi­re­ments of the IVDR. Other­wi­se, manu­fac­tu­r­ers face the thre­at of mea­su­res by the mar­ket sur­veil­lan­ce aut­ho­ri­ties, which may include orders pro­hi­bi­ting them from making their devices available on the mar­ket, as well as recall or with­dra­wal orders. For manu­fac­tu­r­ers of Class A (non-sterile) in-vitro dia­gno­stics and in-vitro dia­gno­stics of all clas­ses who­se decla­ra­ti­on of con­for­mi­ty is issued after 26 May 2022, mar­ket sur­veil­lan­ce mea­su­res may be adopted right now.

The tran­si­tio­nal peri­ods do not affect all requi­re­ments for manufacturers

Some pro­vi­si­ons of the IVDR take effect on 26 May 2022 for all in-vitro dia­gno­stics, regard­less of risk class. From that date for­ward, manu­fac­tu­r­ers will be requi­red to adhe­re to the fol­lo­wing pro­vi­si­ons of the IVDR:

  • the requi­re­ments for post-market sur­veil­lan­ce of their devices through imple­men­ta­ti­on of a sur­veil­lan­ce sys­tem and report­ing on the sur­veil­lan­ce and safe­ty of their devices;
  • the requi­re­ments con­cer­ning vigi­lan­ce with regard to serious inci­dents and field safe­ty cor­rec­ti­ve actions;
  • the requi­re­ments for regis­tra­ti­on of eco­no­mic ope­ra­tors and devices in Eudamed.

In this case as well, vio­la­tors face the thre­at of seve­re mea­su­res by the mar­ket sur­veil­lan­ce aut­ho­ri­ties, inclu­ding pos­si­ble recall or with­dra­wal orders.

Sum­ma­ry

If they have not alre­a­dy done so, manu­fac­tu­r­ers should imme­dia­te­ly com­ply with the IVDR’s requi­re­ments for the regis­tra­ti­on of devices and of the manu­fac­tu­r­ers them­sel­ves, as well as tho­se rela­ting to post-market sur­veil­lan­ce of their devices and vigi­lan­ce requi­re­ments, in order to avo­id mea­su­res by the mar­ket sur­veil­lan­ce authorities.

Regard­less of the risk class of their devices, manu­fac­tu­r­ers are advi­sed to imple­ment the IDVR’s requi­re­ments in a time­ly man­ner and in par­ti­cu­lar to expe­di­te the con­for­mi­ty assess­ment pro­ce­du­re with invol­vement of the noti­fied body. This pro­ce­du­re may take a con­sidera­ble amount of time given the small num­ber of accre­di­ted noti­fied bodies, and manu­fac­tu­r­ers should take this into account in plan­ning for the date on which they will be requi­red to com­ply in full with the IVDR.

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