Draft man­u­fac­tur­er self-dec­la­ra­tion and noti­fied body con­fir­ma­tion let­ter for Reg­u­la­tion (EU) 2024/1860 available

Reg­u­la­tion (EU) 2024/1860 (amend­ing Reg­u­la­tion to the IVDR) pro­vides for an extend­ed tran­si­tion peri­od of IVD med­ical devices. It has been pub­lished in the Offi­cial Jour­nal of the EU (OJEU) and thus entered into force in July 2024. 

To make use of the extend­ed tran­si­tion peri­od, man­u­fac­tur­ers should issue a self-dec­la­ra­tion and be able to present a con­fir­ma­tion let­ter issued by the noti­fied body that will con­duct the IVDR con­for­mi­ty assess­ment. For fur­ther details, please con­sid­er our last newslet­ter issues.

The Euro­pean Com­mis­sion has now pub­lished two drafts for this pur­pose, the draft for the man­u­fac­tur­er self-dec­la­ra­tion can be accessed here, while the draft for the noti­fied body con­fir­ma­tion let­ter can be accessed here. 

Should you need addi­tion­al advice, please don’t hes­i­tate to con­tact our team. Oth­er doc­u­ments of inter­est can be accessed in our library.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Exten­sion of IVDR tran­si­tion peri­ods and ear­ly launch of Eudamed takes last hurdle
• Update on Reg­u­la­tion (EU) 2023/607 – extend­ed MDR tran­si­tion period
• UK MHRA gives CE marked devices new tran­si­tion deadlines
• Extend­ed IVDR tran­si­tion peri­od for cer­tain IVD med­ical devices