On Decem­ber 17, 2019, the final vote for the sec­ond cor­ri­gen­dum to the Med­ical Devices Reg­u­la­tion (2017/745, MDR) took place. It is now offi­cial­ly con­firmed that some class I med­ical devices, for exam­ple reusable sur­gi­cal instru­ments or sub­stance based devices, will be exempt from MDR com­pli­ance until 2024.

Experts were right in assum­ing that the pro­posed doc­u­ment will be adopt­ed unchanged with a very high prob­a­bil­i­ty. One of the most impor­tant aspects of the cor­ri­gen­dum cer­tain­ly is that med­ical devices clas­si­fied as class I under the Med­ical Devices Direc­tive (93/42/EEC, MDD) and up-clas­si­fied under the MDR, will be exempt from MDR com­pli­ance until May 26, 2024. The back­ground for this step appar­ent­ly is that there are not enough Noti­fied Bod­ies to issue the cer­tifi­cates that would have been required and that many devices would have been dis­ap­peared from the mar­ket accordingly.

The most promi­nent groups of devices that may make use of this exemp­tion are:

  1. reusable sur­gi­cal instruments,
  2. soft­ware that would have been up-classified,
  3. sub­stance-based devices (e.g. lubricants),
  4. inhalers

What man­u­fac­tur­ers should bear in mind 

Although this takes some pres­sure from man­u­fac­tur­ers and Noti­fied Bod­ies, it is very impor­tant to not under­stand this as a delay of the MDR as a whole and con­sid­er some impor­tant points:

  1. All class I med­ical devices that will not need a Noti­fied Body under the MDR as well, may not make use of this exemption.
  2. Those man­u­fac­tur­ers who may and will make use of this exemp­tion, must ful­fill the MDR require­ments on PMS, vig­i­lance, eco­nom­ic oper­a­tor reg­is­tra­tion as of May 26, 2020 where­as the lat­ter point is dif­fi­cult to imple­ment as long as EUDAMED is not live. 
  3. Those man­u­fac­tur­ers who may and will make use of this exemp­tion may not imple­ment any sig­nif­i­cant changes to their devices as long as they place their prod­ucts on the mar­ket under the MDD. If they do, they are oblig­ed to com­ply with the new MDR requirements.
  4. Please note that we expect com­pe­tent author­i­ties to require cer­tain improve­ments in the tech­ni­cal doc­u­men­ta­tion for exempt class I prod­ucts nonethe­less. For exam­ple, clin­i­cal eval­u­a­tions in accor­dance with MEDDEV 2.7/1, rev. 4 are gen­er­al­ly expect­ed for all med­ical devices. The same is true for oth­er crit­i­cal doc­u­ments. We thus rec­om­mend a gen­er­al review of your doc­u­men­ta­tion until May 26, 2020 in any case.

Final advice on the MDR cor­ri­gen­dum 2

Also, please be advised to not wait too long. Many man­u­fac­tur­ers of class Is/m, IIa/b and III devices have extend­ed their cer­tifi­cates until 2024. Although we may expect more Noti­fied Bod­ies to be des­ig­nat­ed under the MDR until then, capac­i­ty will still be an issue when these man­u­fac­tur­ers will apply for MDR des­ig­na­tion as well. 

Final­ly, man­u­fac­tur­ers should use their time to col­lect PMCF data on their devices. As men­tioned fre­quent­ly these days, clin­i­cal data require­ments have grown stricter. Should the MDR cor­ri­gen­dum 2 be accept­ed as pro­posed, there will hard­ly be any excuse for clin­i­cal eval­u­a­tions that do not ful­fill the cor­re­spond­ing requirements. 

Source: Sec­ond MDR cor­ri­gen­dum, Medtech Insight (an Infor­ma product)

For fur­ther in depth infor­ma­tion on changes accom­pa­ny­ing the new MDR, we warm­ly rec­om­mend fol­low­ing arti­cles and pages

“News from the Com­mis­sion – Noti­fied Bod­ies and a Poten­tial MDR Exten­sion for Select­ed Devices”
Noti­fied Body Selec­tion and Change
Major Aspects of the MDR
Major Aspects of the IVDR