Tran­si­ti­on from the In-Vitro Dia­gno­stics Direc­ti­ve to the In-Vitro Dia­gno­stics Regu­la­ti­on (IVDR) on 26 May 2022

As of 26 May 2022, the In-Vitro Dia­gno­stics Direc­ti­ve (PDF) will no lon­ger be in effect. It will be repla­ced by the In-Vitro Dia­gno­stics Regu­la­ti­on (IVDR), which will take imme­dia­te effect in EU mem­ber sta­tes on that date, after a five-year tran­si­tio­nal period.

Under the IVDR, signi­fi­cant­ly more pro­ducts than befo­re will have to under­go a con­for­mi­ty assess­ment pro­ce­du­re with the invol­vement of a noti­fied body. In order to ensu­re a smooth tran­si­ti­on from the Direc­ti­ve to the IVDR, eco­no­mic ope­ra­tors were gran­ted a five-year tran­si­tio­nal peri­od expi­ring on 26 May 2022.

Under IVDR rules, about 80 per­cent of IVD manu­fac­tu­r­ers will be requi­red to invol­ve noti­fied bodies in con­for­mi­ty assess­ment pro­ce­du­res for their pro­ducts, com­pared to just about 15 per­cent under the IVD Directive.

This rai­ses a uni­que pro­blem: many of the noti­fied bodies which were gene­ral­ly eli­gi­ble for con­for­mi­ty assess­ment pro­ce­du­res under the IVD Direc­ti­ve have not (yet) under­go­ne accre­di­ta­ti­on pro­ce­du­res in accordance with Artic­le 31 et seq. of the IVDR and have no inten­ti­on of doing so. At things stand (as of 6 August 2021), only five noti­fied bodies in the EU are accre­di­ted in accordance with the IVDR and will have to con­duct con­for­mi­ty assess­ment pro­ce­du­res under the IVDR . Under the Direc­ti­ve, the­re were most recent­ly 18 accre­di­ted noti­fied bodies. This will unde­ni­ably lead to delays in the cer­ti­fi­ca­ti­on of IVDs, which manu­fac­tu­r­ers must be pre­pared for.

In Sep­tem­ber 2018, the EU Com­mis­si­on published tran­si­tio­nal rules (Imple­men­ta­ti­on Rol­ling Plan) in order to ensu­re a smooth tran­si­ti­on from the IVD Direc­ti­ve to the IVDR. But the­se tran­si­tio­nal rules have crea­ted litt­le reli­ef as far as noti­fied bodies are concerned.

The small num­ber of noti­fied bodies is par­ti­cu­lar­ly attri­bu­ta­ble to the fact that, until 26 May 2021, the com­pe­tent bodies were also busy making pre­pa­ra­ti­ons for the Medi­cal Devices Regu­la­ti­on (MDR) and intro­du­cing the rele­vant struc­tures. In order to avo­id bur­de­ning them with both the­se tasks at the same time, the MDR was ori­gi­nal­ly sup­po­sed to take effect on 26 May 2020, so that the com­pe­tent aut­ho­ri­ties would have two years to make the neces­sa­ry pre­pa­ra­ti­ons for the ent­ry into effect of the IVDR on 26 May 2022. But this time was shor­ten­ed by one year becau­se the ent­ry into effect of the MDR had to be post­po­ned by one year, to 26 May 2021, in light of the coro­na­vi­rus pan­de­mic and the asso­cia­ted chal­lenges for the medi­cal devices indus­try, while the ent­ry into effect of the IVDR has yet to be postponed.

But the tran­si­tio­nal rules do crea­te a cer­tain amount of reli­ef as far as the Euda­med data­ba­se is con­cer­ned. While Euda­med is not yet ful­ly func­tion­al, so that not all rele­vant data can be published in the Euda­med data­ba­se, manu­fac­tu­r­ers will be able to com­ply with their requi­re­ments even wit­hout publi­shing the rele­vant data in Euda­med. It is expec­ted that Euda­med will be ful­ly func­tion­al in 2022.

On the who­le, it will be dif­fi­cult to crea­te ade­qua­te infra­struc­tu­re for imple­men­ta­ti­on of the IVDR by the time it enters into effect on 26 May 2022. It would appear sen­si­ble for the EU to post­po­ne the Regu­la­ti­on’s ent­ry into effect in order to ensu­re an ade­qua­te sup­p­ly of urgen­tly nee­ded IVDs. Other­wi­se, the­re is a risk that the stric­ter requi­re­ments for con­for­mi­ty assess­ment pro­ce­du­res will hin­der or delay deve­lo­p­ment and pla­ce­ment on the mar­ket for a lar­ge num­ber of IVDs due to a lack of noti­fied bodies.

Recom­men­ded actions:

IVD manu­fac­tu­r­ers should seek to under­go con­for­mi­ty assess­ment pro­ce­du­res with accre­di­ted noti­fied bodies right away, if they have not done so alre­a­dy, in order to ensu­re that their pro­ducts recei­ve the neces­sa­ry con­for­mi­ty assess­ment by 26 May 2022. Other­wi­se, the­re is a risk that the­se pro­ducts will have to be taken off the market.

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