The first set of EU ref­er­ence lab­o­ra­to­ries (EURLs) have been named in Com­mis­sion Imple­ment­ing Reg­u­la­tion (EU) 2023/2713. EURLs are essen­tial in the assess­ment of high-risk IVD med­ical devices (IVDs).

As a reminder, EURLs have two main types of func­tions: advi­so­ry as well as relat­ed to con­for­mi­ty assess­ment, chiefly of class D IVDs. As regards con­for­mi­ty of class D devices, the EURLs are respon­si­ble for:

  1. Val­i­dat­ing the per­for­mance of these prod­ucts and con­for­mi­ty with com­mon specifications 
  2. Per­form­ing batch test­ing of class D devices.

The des­ig­nat­ed EURLs will become active on 1 Octo­ber 2024. This time will also allow man­u­fac­tur­ers and noti­fied bod­ies to mod­i­fy their processes.

It is impor­tant to note that EURL involve­ment in class D IVDs will only be required for prod­ucts where appli­ca­tions are made to a noti­fied body after the afore­men­tioned date. IVDs that have been cer­ti­fied before 1 Octo­ber 2024 and where appli­ca­tions have already been accept­ed do not need to involve a EURL for val­i­dat­ing the per­for­mance of these prod­ucts and com­pli­ance with com­mon spec­i­fi­ca­tions. Up to now, noti­fied bod­ies have assessed these prod­ucts. Impor­tant­ly, batch ver­i­fi­ca­tion test­ing will apply from 1 Octo­ber 2024 for all class D devices, irre­spec­tive of whether they are already cer­ti­fied or in the process of certification. 

The Imple­ment­ing Reg­u­la­tion con­tains an annex list­ing ref­er­ence lab­o­ra­to­ries accord­ing to ‘spe­cif­ic devices, or cat­e­go­ry or group of devices, or for spe­cif­ic haz­ards relat­ed to a cat­e­go­ry or group of devices’ for which they are autho­rised to test. 

There are ten list­ings to date under the fol­low­ing four categories:

  1. Devices meant for detec­tion or quan­tifi­ca­tion of mark­ers of hepati­tis or retro­virus infection.
  2. Devices aimed at detec­tion or quan­tifi­ca­tion of mark­ers of her­pes virus infection.
  3. Devices intend­ed for detec­tion and quan­tifi­ca­tion of mark­ers of infec­tion with bac­te­r­i­al agents.
  4. Devices planned for detec­tion or quan­tifi­ca­tion of mark­ers of res­pi­ra­to­ry virus infection.

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website