Exten­ded tran­si­ti­on periods

Pro­po­sal for a Regu­la­ti­on amen­ding the MDR and IVDR

The declared objec­ti­ves of the new ver­si­on of the legal frame­work for medi­cal devices and in vitro dia­gno­stics in the form of the Euro­pean Medi­cal Devices Regu­la­ti­on (MDR) and In Vitro Dia­gno­stics Regu­la­ti­on (IVDR), which ente­red into force in 2017, were to impro­ve pati­ent safe­ty and pro­mo­te inno­va­ti­ve pro­ducts. With the signi­fi­cant­ly stric­ter requi­re­ments for eco­no­mic ope­ra­tors and pro­ducts, the need for accre­di­ta­ti­on of alre­a­dy lack­ing Noti­fied Bodies with respect to the new regu­la­ti­ons, and the addi­tio­nal docu­men­ta­ti­on effort requi­red, the oppo­si­te seems to have occur­red. In par­ti­cu­lar, “niche” pro­ducts, espe­ci­al­ly tho­se requi­red for pedia­tric medi­ci­ne, are no lon­ger being manu­fac­tu­red becau­se the increased requi­re­ments no lon­ger make it pro­fi­ta­ble to con­ti­nue pro­du­cing small quan­ti­ties. Exis­ting pro­ducts can­not con­ti­nue to be pla­ced on the mar­ket becau­se “old” cer­ti­fi­ca­tes of Noti­fied Bodies will not be able to be rene­wed (in time) in the fore­seeable future. New, inno­va­ti­ve pro­ducts fail becau­se of the time-to-market “distance” that results from lon­ger con­for­mi­ty assess­ment pro­ce­du­res and the asso­cia­ted cos­ts. The strain on the indus­try in con­nec­tion with the Coro­na pan­de­mic has had a fur­ther nega­ti­ve impact on the unfa­voura­ble incon­gruous situa­ti­on. As a result, the­re has been and con­ti­nues to be a risk of shorta­ges of essen­ti­al and new medi­cal devices, which neither increa­ses pati­ent safe­ty nor pro­mo­tes pro­duct innovation.

To address the­se abu­ses, the EU Commission’s pro­po­sal to amend the MDR and IVDR the­r­e­fo­re pro­vi­des for the following:

1. Exten­si­on of the tran­si­ti­on periods

For medi­cal devices for which a cer­ti­fi­ca­te or decla­ra­ti­on of con­for­mi­ty was issued befo­re 26 May 2021, the tran­si­ti­on peri­od to the new regu­la­ti­ons will be from 26 May 2024 to 31 Decem­ber 2027 for higher-risk devices (Class III and

Class IIb implan­ta­ble devices, with the excep­ti­on of cer­tain devices for which the MDR pro­vi­des exemp­ti­ons) and exten­ded until 31 Decem­ber 2028 for moderate- and lower-risk devices (Class IIb devices and Class IIa, Im, Is, and Ir devices). A tran­si­ti­on peri­od until 26 May 2026 will be intro­du­ced for Class III implan­ta­ble cus­tom devices to give manu­fac­tu­r­ers more time to obtain cer­ti­fi­ca­ti­on from a Noti­fied Body.

  • Class III and IIb implants                     à new dead­line 31 Decem­ber 2027
  • Class IIb and lower                             à new dead­line 31 Decem­ber 2028
  • Class III custom-made pro­ducts         à new dead­line 26 May 2026

Howe­ver: The exten­si­on is sub­ject to cer­tain con­di­ti­ons. Only pro­ducts that are safe and for which manu­fac­tu­r­ers have alre­a­dy taken steps to tran­si­ti­on to the Medi­cal Device Regu­la­ti­ons will bene­fit from the addi­tio­nal time.

2. Wai­ver of “sell by” date

The Com­mis­si­on also pro­po­ses to eli­mi­na­te the “sell by” date curr­ent­ly pro­vi­ded for in Artic­le 120(4) MDR and Artic­le 110(4) IVDR. This is the end date after which pro­ducts that have alre­a­dy been pla­ced on the mar­ket and are still available for purcha­se should be with­drawn. The eli­mi­na­ti­on of this cutoff date is now inten­ded to ensu­re that safe and essen­ti­al medi­cal devices alre­a­dy on the mar­ket con­ti­nue to be available to health care sys­tems and pati­ents in need.


The pro­po­sal on the amend­ments must be adopted by the Euro­pean Par­lia­ment and the Coun­cil. An acce­le­ra­ted co-decision pro­ce­du­re is sti­pu­la­ted for this purpose.

The pro­po­sed chan­ges are reasonable and may result in “reli­ef” for manu­fac­tu­r­ers who will bene­fit from lon­ger time­lines to achie­ve MDR/IVDR com­pli­ance of their pro­ducts. They will also help avo­id bot­t­len­ecks in medi­cal device sup­p­ly. At the same time, the chan­ges do not give manu­fac­tu­r­ers car­te blan­che! Manu­fac­tu­r­ers must con­sider on a case-by-case basis whe­ther the exten­ded tran­si­ti­on peri­ods can actual­ly be appli­ed to their pro­ducts and con­ti­nue to work to achie­ve MDR/IVDR com­pli­ance as quick­ly as possible.


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