Intro­duc­tion of EUDAMED postponed!

The new Euro­pean regu­la­ti­ons for the deve­lo­p­ment, manu­fac­tu­re, mar­ke­ting and pro­duct moni­to­ring of medi­cal devices within the EU in the form of the MDR and IVDR requi­re manu­fac­tu­r­ers to store pro­duct and manufacturer-related data in the EUDAMED data­ba­se. EUDAMED is con­side­red by indus­try experts to be a key ele­ment of the new regu­la­to­ry frame­work and is inten­ded in par­ti­cu­lar to impro­ve mar­ket sur­veil­lan­ce, ensu­re the exch­an­ge of infor­ma­ti­on on cli­ni­cal tri­al data and con­tri­bu­te to the uni­form appli­ca­ti­on of the regulations.

The ori­gi­nal plan was for manu­fac­tu­r­ers and other eco­no­mic ope­ra­tors to enter their data into the EUDAMED data­ba­se when the MDR came into force on 26 May 2020. The Euro­pean legis­la­tor had pro­vi­ded for an 18-month tran­si­ti­on peri­od during which manu­fac­tu­r­ers were to record all rele­vant data on their pro­ducts (inclu­ding tho­se still mar­ke­ted under the MDD).

This week, what had been loo­ming and feared for some time has now been con­firm­ed: the go-live date for EUDAMED has been post­po­ned by a full two years.

The reasons given for the post­po­ne­ment of the plan­ned launch date are neces­sa­ry impro­ve­ments to the data­ba­se. The plan­ned impro­ve­ments mean that the data­ba­se can­not be put into ope­ra­ti­on until the enti­re sys­tem and its modu­les have rea­ched full func­tion­a­li­ty and have under­go­ne inde­pen­dent test­ing. The acti­va­ti­on of indi­vi­du­al modu­les is the­r­e­fo­re to be refrai­ned from. The mar­ket launch of EUDAMED for medi­cal devices and in vitro medi­cal devices tog­e­ther is now sche­du­led for the date ori­gi­nal­ly plan­ned for the IVDR, name­ly 26 May 2022.

Impact of the post­po­ne­ment on manufacturers

Despi­te its importance within the MDR regu­la­to­ry frame­work, this post­po­ne­ment of the launch date of EUDAMED has no impact on the date of appli­ca­ti­on of the MDR its­elf. Regard­less of demands from indus­try, 26 May 2020 is still the plan­ned date of appli­ca­ti­on. Manu­fac­tu­r­ers are the­r­e­fo­re still well advi­sed to make their com­pa­nies and pro­ducts MDR-compliant in order to be rea­dy for the MDR launch date and to be able to con­ti­nue mar­ke­ting their pro­ducts. Regis­tra­ti­on within Ger­ma­ny will initi­al­ly con­ti­nue via the DIMDI database.