2. Cor­ri­gen­dum for MDR Artic­le 120 (3) brought signi­fi­cant relief.

The new Medi­cal Device Regu­la­ti­on (Regu­la­ti­on 2017/745) (PDF) enters into bin­ding effect on 26 May 2020. The MDR con­ta­ins requi­re­ments for the deve­lo­p­ment, manu­fac­tu­re, pro­vi­si­on of use infor­ma­ti­on and pro­duct sur­veil­lan­ce of medi­cal devices which repre­sent far grea­ter hurd­les than tho­se which are curr­ent­ly in place under the MDD, AIMD and IVDD. The chan­ges pose new chal­lenges for manu­fac­tu­r­ers, par­ti­cu­lar­ly with regard to the con­tent of tech­ni­cal docu­men­ta­ti­on, cli­ni­cal eva­lua­tions and post-market sur­veil­lan­ce. The sca­le of the new requi­re­ments may and often does result in a stric­ter and the­r­e­fo­re lon­ger con­for­mi­ty assess­ment pro­ce­du­res, mea­ning a lon­ger time-to-market for new devices.

2. Cor­ri­gen­dum to the MDR

For manu­fac­tu­r­ers of Class I devices, the 2nd Cor­ri­gen­dum to the MDR (PDF), dated 25 Novem­ber 2019, has brought signi­fi­cant relief.

Ins­tead of the ori­gi­nal text of Artic­le 120 (3):
“By way of dero­ga­ti­on from Artic­le 5 of this Regu­la­ti­on, a device with a cer­ti­fi­ca­te that was issued in accordance with Direc­ti­ve 90/385/EEC or Direc­ti­ve 93/42/EEC and which is valid by vir­tue of para­graph 2 of this Artic­le may only be pla­ced on the mar­ket or put into ser­vice pro­vi­ded that from the date of appli­ca­ti­on of this Regu­la­ti­on it continues …”

Artic­le 120 (3) will now read as fol­lows:
“By way of dero­ga­ti­on from Artic­le 5 of this Regu­la­ti­on, a device which is a class I device pur­su­ant to Direc­ti­ve 93/442/EEC, for which the decla­ra­ti­on of con­for­mi­ty was drawn up pri­or to 26 May 2020 and for which the con­for­mi­ty assess­ment pro­ce­du­re pur­su­ant to this Regu­la­ti­on requi­res the invol­vement of a noti­fied body, or which has a cer­ti­fi­ca­te that was issued in accordance with Direc­ti­ve 90/385/EEC or Direc­ti­ve 93/442/EEC and that is valid by vir­tue of para­graph 2 of this Artic­le, may be pla­ced on the mar­ket or put into ser­vice until 26 May 2024, pro­vi­ded that from 26 May 2020 it continues …”

In other words, the “hard dead­line” of May 2020 will no lon­ger app­ly, at least for the devices which are expli­cit­ly men­tio­ned in Artic­le 120 (3).

Bene­fi­ci­a­ries of the dead­line extension

Manu­fac­tu­r­ers of Class I medi­cal devices under the curr­ent­ly appli­ca­ble MDD who­se pro­ducts would be assi­gned to a hig­her class under MDR rules may con­ti­nue to mar­ket their pro­ducts through 26 May 2024, pro­vi­ded that they are in con­for­mance with the MDD. This appli­es e.g. for reusable sur­gi­cal­ly inva­si­ve devices clas­si­fied as Class I (under the new MDR; Annex VIII, 5.2, Rule 6, second bul­let point of the MDR), which bene­fit from the new tran­si­tio­nal peri­od pro­vi­ded a decla­ra­ti­on of con­for­mi­ty exists for them under the MDD.

Medi­cal apps are clas­si­fied in accordance with Rule 11 (Annex VIII, 6.3). Accor­din­gly, they are typi­cal­ly clas­si­fied as Class IIa or hig­her under the MDR. Manu­fac­tu­r­ers of medi­cal apps which are pre­sent­ly clas­si­fied as Class I under MDD/IVDD rules, and which would be assi­gned to a hig­her class under MDR rules, will also bene­fit from the extension.

The dead­line exten­si­on also bene­fits manu­fac­tu­r­ers of devices com­pri­sed of sub­s­tances and gene­ral­ly pro­vi­des noti­ceable reli­ef for manu­fac­tu­r­ers of Class I devices, which face spe­cial requi­re­ments for the first time under the MDR.

Important: if devices which are mar­ke­ted under the MDD during the exten­ded tran­si­tio­nal peri­od under­go a “signi­fi­cant chan­ge” after the MDR takes effect, i.e. a chan­ge which could impact the con­for­mi­ty of the device, the chan­ge and the device’s con­for­mi­ty are to be asses­sed under MDR rules, even during the exten­ded tran­si­tio­nal period.

Reasons for the extension

Accor­ding to Germany’s Fede­ral Health Minis­try, the recent­ly adopted exten­si­on is desi­gned in part to address defi­ci­en­ci­es rela­ting to noti­fied bodies and ensu­re equal tre­at­ment for manu­fac­tu­r­ers of Class I devices and manu­fac­tu­r­ers of high-risk devices.


Regard­less of the new tran­si­tio­nal peri­ods, the neces­sa­ry steps to imple­ment the MDR should not be post­po­ned by any means. For one thing, the exten­ded tran­si­tio­nal peri­od will end on 26 May 2024. Second­ly, Artic­le 120 (3) also sta­tes that the MDR’s requi­re­ments rela­ting to post-market sur­veil­lan­ce, mar­ket sur­veil­lan­ce, vigi­lan­ce, regis­tra­ti­on of mar­ket ope­ra­tors and regis­tra­ti­on of devices will app­ly in place of the cor­re­spon­ding requi­re­ments in tho­se two Direc­ti­ves; and the dead­line for the­se requi­re­ments has not been extended.


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