Grace peri­od for IVDR compliance

For manu­fac­tu­rers, the chan­ge from the IVD Direc­ti­ve 98/79/EC (IVDD) (PDF) to Regu­la­ti­on 2017/746 (IVDR) (PDF) means, among other things, that a lar­ge num­ber of their pro­ducts will be sub­ject to new clas­si­fi­ca­ti­on rules. This makes it necessa­ry to invol­ve a Noti­fied Body in the con­for­mi­ty assess­ment pro­ce­du­re for approx. 80% of pro­ducts. Under the IVDD, this was the case for only about 15% of in vitro dia­gnostic (IVD) devices. At the same time, the num­ber of Noti­fied Bodies that can demons­tra­te accredi­ta­ti­on for IVD has decre­a­sed. As of 5 Janu­a­ry 2022, the­re are exact­ly 6 Noti­fied Bodies lis­ted on Nando.

It is the­re­fo­re clear that when the IVDR comes into for­ce on 26 May 2022, a lar­ge pro­por­ti­on of IVDs will not be able to be pla­ced on the mar­ket in con­for­mi­ty with the IVDR due to a lack of suf­fi­ci­ent capa­ci­ty on the part of Noti­fied Bodies. In fact, it has not yet been pos­si­ble for a lar­ge num­ber of manu­fac­tu­rers to car­ry out a con­for­mi­ty assess­ment pro­ce­du­re for their pro­duct that meets the requi­re­ments of the IVDR with the invol­ve­ment of a Noti­fied Body. The­re is a thre­at of a sup­ply shor­ta­ge of IVDs, which, at mini­mum, could affect SARS-CoV‑2 testing.

New tran­si­ti­on peri­ods – Com­mis­si­on proposal

In view of this situa­ti­on, the EU Com­mis­si­on publis­hed a pro­po­sal (PDF) for an amend­ment (PDF) to the IVDR in Octo­ber 2021, which was aimed at exten­ding the tran­si­ti­on peri­ods from the IVDD to the IVDR and has sin­ce been adop­ted by the EU Par­lia­ment and Coun­cil. Accord­ing to the imple­men­ted pro­po­sal, IVDs pla­ced on the mar­ket and cer­ti­fied accord­ing to the pre­vious rules of the IVDD should be able to con­ti­nue to be pla­ced on the mar­ket and sold. Depen­ding on the risk class, the new tran­si­ti­on peri­ods for pla­cing the pro­ducts on the mar­ket will end on 26 May 2025, 2026 or 2027. The sell-off rule allows the sale of pro­ducts alrea­dy pla­ced on the mar­ket for a fur­ther year after the end of the respec­ti­ve tran­si­tio­nal period.

The new rules affect pro­ducts in inventories,

1.    for which con­for­mi­ty accord­ing to IVDD was alrea­dy decla­red befo­re 26 May 2022, and
2.    that fall under clas­ses D, C, B or A (ste­ri­le) in accordance with the IVDR.

New dead­lines do not app­ly to all IVDs

Con­ver­se­ly, the new rules do not app­ly to products

1.    for which a decla­ra­ti­on of con­for­mi­ty will not be issued until 26 May 2022 or
2.    which fall under Class A (non-sterile) in accordance with the IVDR.

The fol­lowing is the­re­fo­re cer­tain: For manu­fac­tu­rers of non-sterile IVDs sub­ject to Class A in accordance with the IVDR, the dead­line of 26 May 2022 is set in stone. It is man­da­to­ry that their pro­ducts be IVDR com­pli­ant by the dead­line. Sin­ce the invol­ve­ment of a Noti­fied Body is not fore­se­en for the con­for­mi­ty assess­ment of the­se pro­ducts, the time­ly and pro­per imple­men­ta­ti­on of a cor­re­spon­ding con­for­mi­ty assess­ment pro­ce­du­re does not depend on the manu­fac­tu­rers’ suc­cess in gai­ning the sup­port of one of the few accredi­ted Noti­fied Bodies. Con­se­quent­ly, manu­fac­tu­rers do not bene­fit from the exten­ded tran­si­ti­on peri­od. This also app­lies to new IVDs the con­for­mi­ty of which has not yet been decla­red in accordance with the rules of the IVDD. For the­se “non-stock” pro­ducts, too, the effec­ti­ve date of the IVDR on 26 May 2022 is bin­ding and can­not be “post­po­ned” any further.

Date of app­li­ca­ti­on of the IVDR remains unaffected

It is important to empha­sise that des­pi­te the new tran­si­ti­on rules, the­re is no chan­ge to the basic effec­ti­ve date of the IVDR as of 26 May 2022. This affects the obli­ga­ti­ons of manu­fac­tu­rers for pro­duct moni­to­ring and vigi­lan­ce, but also the moni­to­ring by the com­pe­tent aut­ho­ri­ties: The rules of the IVDR app­ly to all pro­ducts, regard­less of whe­ther or not they are still IVDD-compliant and have been pla­ced on the mar­ket in accordance with the new tran­si­ti­on periods.

In addi­ti­on, simi­lar to the rules of the MDR, no fur­ther signi­fi­cant chan­ges may be made to the pro­ducts them­sel­ves or their inten­ded use wit­hin the tran­si­ti­on peri­od. If chan­ges are made, manu­fac­tu­rers are obli­ged to make the pro­ducts ful­ly IVDR-compliant. 

Recom­men­da­ti­on for action

With the exten­ded tran­si­ti­on peri­ods, the requi­re­ment to place IVDs on the mar­ket in con­for­mi­ty with the rules of the IVDR has not been remo­ved, but merely post­po­ned. In addi­ti­on, the tran­si­ti­on peri­ods do not app­ly to all pro­ducts or to all regu­la­to­ry con­tent of the IVDR. If they have not alrea­dy done so, manu­fac­tu­rers should the­re­fo­re obtain an over­view of the app­li­ca­bi­li­ty of the tran­si­ti­on peri­ods in rela­ti­on to their pro­duct port­fo­lio and also make every effort to imple­ment the requi­re­ments of the IVDR as quick­ly as pos­si­ble, irre­spec­ti­ve of the clas­si­fi­ca­ti­on of their IVD.

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