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.


Stay up-to-date

We use your email address exclusively for sending our newsletter. You have the right to revoke your consent at any time with effect for the future. For further information, please refer to our privacy policy.