The Euro­pean Com­mis­sion has pub­lished a first revi­sion of its Q&A doc­u­ment regard­ing the imple­men­ta­tion of the amend­ing reg­u­la­tion (EU) 2023/607 to the med­ical devices reg­u­la­tion (MDR). 

Updates have been made to sec­tion 7 on how a man­u­fac­tur­er can demon­strate that its lega­cy device can prof­it from the exten­sion of the tran­si­tion peri­od. The orig­i­nal doc­u­ment had stat­ed that asso­ci­at­ed con­fir­ma­tion let­ters should be based on a har­monised tem­plate. In the most recent revi­sion, the doc­u­ment says that the man­u­fac­tur­er could also demon­strate hav­ing applied for con­for­mi­ty assess­ment and arranged a writ­ten agree­ment with a noti­fied body by anoth­er method, for exam­ple, a copy of the rel­e­vant doc­u­ment. 

In addi­tion, new appen­dices have been added link­ing with a tem­plate for a manufacturer’s dec­la­ra­tion and a tem­plate for noti­fied body con­fir­ma­tion letter. 

Editor’s note: Draft tem­plates for man­u­fac­tur­ers’ self-dec­la­ra­tions and noti­fied body con­fir­ma­tion let­ters are avail­able on the web­site of the Euro­pean Commission. 

Oth­er changes gen­er­at­ed by addi­tions to Q&As in the orig­i­nal text are among others:

  1. A noti­fied body let­ter noti­fy­ing about the expiry of the cer­tifi­cate, or a con­trolled phase-out of pro­duc­tion agreed between noti­fied body and man­u­fac­ture because of the expiry of a cer­tifi­cate before 20 March 2023 are not deemed as with­draw­al of a certificate. 
  2. As regards the infor­ma­tion pre­sent­ed by the man­u­fac­tur­er or the autho­rised rep­re­sen­ta­tive with their for­mal appli­ca­tion to a noti­fied body for con­for­mi­ty assess­ment under the MDR as a step being able to take advan­tage of the extend­ed tran­si­tion­al peri­od, the sub­mis­sion of infor­ma­tion requires the pos­si­bil­i­ty for the noti­fied body to add the rel­e­vant dig­i­tal document(s) to its files. Con­se­quent­ly, a ‘read only’ access to the manufacturer’s elec­tron­ic data plat­form is not enough. 
  3. To facil­i­tate the noti­fied body to com­plete the sur­veil­lance and make the required arrange­ments with the man­u­fac­tur­ers, a pre­vi­ous noti­fied body must advise any new noti­fied body that is involved with the same device about the device(s) requir­ing appro­pri­ate sur­veil­lance, espe­cial­ly when sur­veil­lance activ­i­ties have not been ongo­ing, for instance, if the cer­tifi­cate expired before 20 March 2023.

Fur­ther con­sid­er­a­tions include but are not lim­it­ed to:

Sec­tion 6.1. asks if a nation­al dero­ga­tion grant­ed in accor­dance with arti­cle 59 of the MDR, or the appli­ca­tion of arti­cle 97 under the MDR, after March 2023 trig­ger the exten­sion of the tran­si­tion­al peri­od. The answer is no. Where after 20 March 2023, a com­pe­tent author­i­ty has con­sent­ed to a dero­ga­tion in accor­dance with arti­cle 59, or has insist­ed on, in line with arti­cle 97, to per­form the applic­a­ble con­for­mi­ty assess­ment pro­ce­dure, the con­di­tions for the extend­ed tran­si­tion peri­od is not met. So, an expired cer­tifi­cate will not be deemed as valid.

The orig­i­nal Q&A doc­u­ment was made pub­lic on March 24 and is intend­ed for com­pa­nies want­i­ng to take advan­tage of the extend­ed tran­si­tion peri­ods for their lega­cy products.

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website