The Euro­pean Par­lia­ment has offi­cial­ly accept­ed the Euro­pean Com­mis­sion pro­pos­al regard­ing extend­ed tran­si­tion time­lines for lega­cy devices under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR). There are also changes to Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR). For IVDR lega­cy devices, there will be no exten­sion of time­lines, but only a removal of the sell-off peri­od (see fur­ther below in this article).

The pro­pos­al is still to be pub­lished in the Offi­cial Jour­nal of the EU. Fol­low­ing this pro­ce­dure the pro­pos­al will offi­cial­ly be adopt­ed. It is expect­ed that this last step will fol­low short­ly, prob­a­bly mid March.

The orig­i­nal text was not amend­ed, so the pro­vi­sions remain the same as described below.

Lega­cy devices with an MDD/ AIMDD noti­fied body certificate

For man­u­fac­tur­ers of lega­cy devices with an MDD/ AIMDD noti­fied body cer­tifi­cate, there are cer­tain eli­gi­bil­i­ty cri­te­ria to make use of the extend­ed tran­si­tion peri­od, i.e. the cer­tifi­cate must be valid by the date of adop­tion of the pro­pos­al. If this is not the case and the cer­tifi­cate expired before the adop­tion date, the fol­low­ing con­di­tions must be fulfilled:

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

Lega­cy devices with­out an MDD/ AIMDD noti­fied body certificate

For man­u­fac­tur­ers of class I lega­cy devices who require noti­fied body involve­ment due to changed clas­si­fi­ca­tion rules under the MDR and thus do not have an MDD/ AIMDD noti­fied body cer­tifi­cate the afore­men­tioned eli­gi­bil­i­ty cri­te­ria do not apply. 

Gen­er­al con­di­tions for lega­cy devices

The pro­pos­al also pro­vides some con­di­tions that must be gen­er­al­ly ful­filled by man­u­fac­tur­ers of lega­cy devices to make use of the new time­lines. Please find below the most impor­tant points:

  1. devices con­tin­ue to com­ply with Direc­tive 90/385/EEC or Direc­tive 93/42/EEC, as applicable; 
  2. there are no sig­nif­i­cant changes in the design and intend­ed purpose; 
  3. 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; 
  4. no lat­er than 26 May 2024, the man­u­fac­tur­er has put in place a qual­i­ty man­age­ment sys­tem in accor­dance with Arti­cle 10(9);
  5. 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 (MDR) for con­for­mi­ty assess­ment in respect of a device that is eli­gi­ble to make use of the extend­ed tran­si­tion peri­od 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 (MDR).

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

New tran­si­tion timelines

If the afore­men­tioned con­di­tions are ful­filled, the cor­re­spond­ing man­u­fac­tur­ers may make use of extend­ed tran­si­tion timelines:

  1. 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;
  2. 31 Decem­ber 2028, for class IIb devices oth­er than those cov­ered by point (a) above, for class IIa devices, and for class I devices placed on the mar­ket in ster­ile con­di­tion or hav­ing a mea­sur­ing function;
  3. 31 Decem­ber 2028, for class I devices that need noti­fied body involve­ment due to amend­ed MDR clas­si­fi­ca­tion rules (e.g. reusable sur­gi­cal instruments).

Sell-off peri­od removed for MDR and IVDR lega­cy devices

As a final point, the pro­pos­al sug­gests to sus­pend the sell-off peri­od for both Reg­u­la­tions. Orig­i­nal­ly, the MDR and IVDR required devices that have already been placed on the mar­ket before the date of appli­ca­tion of the Reg­u­la­tions or for lega­cy devices that have been placed on the mar­ket with­in the defined tran­si­tion peri­ods to be made avail­able or put into ser­vice until May 27, 2025.

This dead­line has now been sus­pend­ed. In sim­pli­fied words, this means that devices that have been sent to a distributor’s ware­house in Europe can be sold off to end clients with­out any time lim­i­ta­tion – pro­vid­ed they have been shipped before the MDR or IVDR appli­ca­tion date or in accor­dance with the MDR and IVDR tran­si­tion time­lines respectively. 

UK

It is under­stood that the MHRA is cur­rent­ly still con­sid­er­ing the con­se­quences of the pro­pos­al and its accep­tance of CE marked devices for the Great Britain market.

Gen­er­al considerations

Man­u­fac­tur­ers should not under­stand the pro­pos­al as an oppor­tu­ni­ty to delay the MDR tran­si­tion. Con­sid­er­ing the require­ments to make use of the extend­ed tran­si­tion peri­od, it becomes clear that this will only apply for man­u­fac­tur­ers who have well pro­ceed­ed with their MDR tran­si­tion process.

Fur­ther­more, it is not yet entire­ly clear how exact­ly the ful­fill­ment of the cor­re­spond­ing require­ments is ver­i­fied and who will be respon­si­ble for this.

Source: Euro­pean Com­mis­sion, Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend to browse mdi-europa.com by tag “Lega­cy Devices”.