MDR extend­ed tran­si­tion peri­od and noti­fied body agreement

Today, Sep­tem­ber 26, 2024, marks the day by when man­u­fac­tur­ers of lega­cy devices in accor­dance with the med­ical devices reg­u­la­tion (MDR) must have avail­able a writ­ten agree­ment with a noti­fied body for MDR con­for­mi­ty assess­ment (sec­tion 4.3, annex VII, MDR). 

This con­di­tion to make use of the extend­ed tran­si­tion peri­od is laid out under arti­cle 120, sec­tion 3c, point e of the MDR. Man­u­fac­tur­ers who have not pro­vid­ed for the cor­re­spond­ing agree­ment with their noti­fied body may not place their lega­cy devices on the Union market.

Source: MDR 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Amend­ing Reg­u­la­tion (EU) 2024/1860 pub­lished in the OJEU
• UK MHRA gives CE marked devices new tran­si­tion deadlines
• Swiss Fed­er­al Coun­cil to mir­ror extend­ed tran­si­tion time­lines for MDR lega­cy devices