The Euro­pean Com­mis­sion has offi­cial­ly pro­posed extend­ed tran­si­tion time­lines for lega­cy devices under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR).

Please note that this is a pro­pos­al and still must be adopt­ed before it becomes legal­ly valid.

The pro­pos­al defines new tran­si­tion timelines:

31 Decem­ber 2027, for class III devices and for class IIb implantable devices, except sutures, sta­ples, den­tal fill­ings, den­tal braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;

31 Decem­ber 2028, for class IIb devices oth­er than those cov­ered by point (a), for class IIa devices, and for class I devices placed on the mar­ket in ster­ile con­di­tion or hav­ing a mea­sur­ing function;

31 Decem­ber 2028, for class I devices that need noti­fied body involve­ment due to amend­ed MDR clas­si­fi­ca­tion rules (e.g. reusable sur­gi­cal instruments).

The pro­pos­al also pro­vides some con­di­tions that must be ful­filled to make use of the new time­lines. Below you will find the most impor­tant points:

(a) devices con­tin­ue to com­ply with Direc­tive 90/385/EEC or Direc­tive 93/42/EEC, as applicable; 

(b) there are no sig­nif­i­cant changes in the design and intend­ed purpose; 

(c) devices do not present an unac­cept­able risk to the health or safe­ty of patients, users or oth­er per­sons, or to oth­er aspects of the pro­tec­tion of pub­lic health; 

(d) no lat­er than 26 May 2024, the man­u­fac­tur­er has put in place a qual­i­ty man­age­ment sys­tem in accor­dance with Arti­cle 10(9);

(e) no lat­er than 26 May 2024, the man­u­fac­tur­er, or an autho­rised rep­re­sen­ta­tive, has lodged a for­mal appli­ca­tion in accor­dance with Sec­tion 4.3, first sub­para­graph, of Annex VII for con­for­mi­ty assess­ment in respect of a device referred to in para­graphs 3b and 3c of this Arti­cle or in respect of a device intend­ed to sub­sti­tute that device, and no lat­er than 26 Sep­tem­ber 2024 the noti­fied body and the man­u­fac­tur­er have signed a writ­ten agree­ment in accor­dance with Sec­tion 4.3, sec­ond sub­para­graph, of Annex VII.

Please note that still in par­al­lel, man­u­fac­tur­ers of lega­cy devices must already com­ply with the MDR require­ments on PMS, vig­i­lance, reg­is­tra­tion and mar­ket surveillance. 

Fur­ther­more, for man­u­fac­tur­ers of lega­cy devices with an MDD/ AIMDD noti­fied body cer­tifi­cate, the cer­tifi­cate must be valid by the date of adop­tion of the pro­pos­al. If this is not the case, i.e. if the cer­tifi­cate expired before the adop­tion date, the fol­low­ing con­di­tions must be ful­filled in addition:

(a) before the date of expiry of the cer­tifi­cate, the man­u­fac­tur­er and a noti­fied body have signed a writ­ten agree­ment in accor­dance with Sec­tion 4.3, sec­ond sub­para­graph, of Annex VII for the con­for­mi­ty assess­ment in respect of the device cov­ered by the expired cer­tifi­cate or in respect of a device intend­ed to sub­sti­tute that device;

(b) a com­pe­tent author­i­ty of a Mem­ber State has grant­ed a dero­ga­tion from the applic­a­ble con­for­mi­ty assess­ment pro­ce­dure in accor­dance with Arti­cle 59(1) or has required the man­u­fac­tur­er, in accor­dance with Arti­cle 97(1), to car­ry out the applic­a­ble con­for­mi­ty assess­ment procedure’.

As a final point, the pro­pos­al sug­gests to sus­pend the sell-off peri­od for devices that have already been placed on the mar­ket before the date of appli­ca­tion of the Regulations.

Stake­hold­ers may pro­vide feed­back to the pro­pos­al until Jan­u­ary 18, so it is antic­i­pat­ed that the Com­mis­sion seeks a time­ly final­iza­tion of the process.

Please let us know should you require addi­tion­al details.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

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