Amend­ing Reg­u­la­tion (EU) 2023/ 607 on the fur­ther extend­ed MDR tran­si­tion peri­ods does not direct­ly affect Eudamed as dead­lines for the appli­ca­tion of the Eudamed med­ical device data­base remain unchanged. 

But man­u­fac­tur­ers have to be aware that there are also require­ments for vig­i­lance which may neces­si­tate pre-reg­is­tra­tion in the devices module. 

The rules are spec­i­fied in the amend­ing reg­u­la­tion and declare that once man­u­fac­tur­ers have been accept­ed by a noti­fied body in the con­text of the EU MDR, that noti­fied body is then respon­si­ble for super­vis­ing vig­i­lance activ­i­ties con­cern­ing the company’s prod­ucts. This could lead to noti­fied bod­ies putting pres­sure on com­pa­nies to reg­is­ter their prod­ucts as soon as possible.

In addi­tion, man­u­fac­tur­ers should keep up with their prepa­ra­tion for reg­is­tra­tion in Eudamed and not wait until the dead­line which could cause a tail­back of appli­ca­tions. Busi­ness­es should be famil­iar with the var­i­ous Eudamed time­lines, pre­pare their data soon enough and reg­is­ter at the ear­li­est oppor­tu­ni­ty. An extra advan­tage of reg­is­ter­ing lega­cy devices is being able to dis­close the full his­to­ry of a prod­uct because both data con­cern­ing lega­cy devices and MDR-reg­u­lat­ed prod­ucts will then be open­ly avail­able in Eudamed. This is also valu­able because importers and dis­trib­u­tors are now look­ing at Eudamed as a prod­uct cat­a­logue let­ting them inspect device history. 

When it comes to Eudamed, as soon as the data­base is ful­ly oper­a­tional, which should be Decem­ber 2024, all seri­ous inci­dents must be giv­en in via the vig­i­lance mod­ule with­in the giv­en time­lines. In order to sub­mit an inci­dent in the data­base, the device must be already reg­is­tered in Eudamed. Find­ing the rel­e­vant data and reg­is­ter­ing a device in Eudamed will take a long time. The com­pa­ny must first be reg­is­tered in the actor mod­ule, which can take some time, before the device can be registered. 

To sum­ma­rize, see­ing that the amend­ing reg­u­la­tion will per­mit lega­cy devices to be sold until 2027/28, from a risk man­age­ment posi­tion it is safer to reg­is­ter these devices way before Eudamed is ful­ly in operation. 

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

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