The Euro­pean Com­mis­sion adopt­ed two del­e­gat­ed reg­u­la­tions on 20 March 2026 that reduce con­for­mi­ty assess­ment bur­dens for man­u­fac­tur­ers of cer­tain implantable and class III med­ical devices. Both instru­ments were pend­ing pub­li­ca­tion in the Offi­cial Jour­nal of the Euro­pean Union (OJEU) at the time of writ­ing and will enter into force only upon that publication.

The first reg­u­la­tion (C(2026)1809) expands the list of class IIb implantable device types exempt from full tech­ni­cal doc­u­men­ta­tion assess­ment for every indi­vid­ual device. Man­u­fac­tur­ers of cov­ered device types will ben­e­fit from reduced noti­fied body review workload.

The sec­ond reg­u­la­tion (C(2026)1798) broad­ens the list of implantable and class III devices qual­i­fy­ing as well-estab­lished tech­nolo­gies (WET), exempt­ing them from the default require­ment to con­duct clin­i­cal investigations. 

Reg­u­la­to­ry affairs teams should map both amend­ments against their port­fo­lios now and mon­i­tor OJEU pub­li­ca­tion for entry-into-force pro­vi­sions before revis­ing con­for­mi­ty assess­ment strategies.

Source: Euro­pean Commission 

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