On 29 June 2026, the Euro­pean Com­mis­sion pub­lished two del­e­gat­ed reg­u­la­tions in the Offi­cial Jour­nal of the EU that broad­en the cat­e­go­ry of “well-estab­lished tech­nolo­gies” (WET) under the Med­ical Devices Reg­u­la­tion (MDR).

WET devices are rel­a­tive­ly sim­ple prod­ucts with com­mon, sta­ble designs, well-char­ac­terised safe­ty and clin­i­cal per­for­mance, and a long mar­ket his­to­ry. Expand­ing the list allows cer­tain MDR require­ments to apply more pro­por­tion­ate­ly to these devices, reduc­ing man­u­fac­tur­er bur­den in line with the Commission’s sim­pli­fi­ca­tion agen­da. The list was devel­oped dur­ing 2025 by a ded­i­cat­ed Task Force of nation­al experts under the Med­ical Device Coor­di­na­tion Group (MDCG), fol­low­ing a call for evi­dence with stake­hold­er input.

The two acts are:

Both will make life eas­i­er for man­u­fac­tur­ers as they reduce the range of devices for which a clin­i­cal inves­ti­ga­tion is required by default. At the same time noti­fied body review activ­i­ties are reduced for a larg­er range of devices with the updat­ed provisions. 

The acts entered into force 20 days after pub­li­ca­tion. Man­u­fac­tur­ers of affect­ed devices should review whether their prod­ucts now qual­i­fy for these exemp­tions and adjust con­for­mi­ty assess­ment plan­ning accordingly. 

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website