Fol­low­ing amend­ing Reg­u­la­tion (EU) 2023/607 on the extend­ed tran­si­tion peri­od for med­ical devices under the MDR and removal of sell-off peri­ods under the MDR and IVDR, the Euro­pean Com­mis­sion has set up a Q&A doc­u­ment to pro­vide guid­ance on the most urgent questions. 

The doc­u­ment address­es 17 questions:

  1. Which devices can ben­e­fit from the extend­ed tran­si­tion­al period?
  2. Can devices that have already been cer­ti­fied in accor­dance with the MDR ben­e­fit from extend­ed tran­si­tion­al period?
  3. What about ‘lega­cy devices’ for which the man­u­fac­tur­er does not wish to apply under the MDR?
  4. Which clas­si­fi­ca­tion rules apply to deter­mine whether the extend­ed tran­si­tion­al peri­od ends on 31 Decem­ber 2027 or on 31 Decem­ber 2028?
  5. Does the extend­ed tran­si­tion­al peri­od also apply to cus­tom-made devices?
  6. If a cer­tifi­cate has expired before 20 March 2023 and a com­pe­tent author­i­ty has grant­ed a dero­ga­tion in accor­dance with Arti­cle 59 MDR or has applied Arti­cle 97 MDR, how long is the tran­si­tion­al period?
  7. How can the man­u­fac­tur­er demon­strate that its lega­cy device ben­e­fits from the exten­sion of the tran­si­tion­al period?
  8. What are the nec­es­sary ele­ments of a for­mal appli­ca­tion lodged by the manufacturer?
  9. What are the nec­es­sary ele­ments of a writ­ten agree­ment between the man­u­fac­tur­er and the noti­fied body?
  10. What is the mean­ing of “device intend­ed to sub­sti­tute that device”?
  11. Which evi­dence does the man­u­fac­tur­er have to pro­vide for hav­ing put in place a QMS in accor­dance with the MDR?
  12. Do man­u­fac­tur­ers, which have lodged an appli­ca­tion for con­for­mi­ty assess­ment and have con­clud­ed a writ­ten agree­ment with a noti­fied body before 20 March 2023, have to lodge a new appli­ca­tion and/or con­clude a new writ­ten agreement?

The remain­ing five ques­tions relate to sce­nar­ios where a man­u­fac­tur­er changed the noti­fied body for the MDR con­for­mi­ty assess­ment and to the sell-off period.

While some of the answers seem to con­vey obvi­ous details, oth­ers pro­vide valu­able infor­ma­tion. For exam­ple, the answer on ques­tion 7 sug­gests a self-dec­la­ra­tion issued by the man­u­fac­tur­er in com­bi­na­tion with a con­fir­ma­tion by the noti­fied body and poten­tial­ly a cer­tifi­cate of free sale by the com­pe­tent author­i­ty.

It remains to be seen in how far the sug­ges­tions can be estab­lished in prac­tice. Should you wish mdi Europa to sub­mit the Q&A doc­u­ment or if you need fur­ther advice, please let us know.

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

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

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