ISO 10993-1:2025 (Edi­tion 6) was pub­lished in Novem­ber 2025. It replaces the 2018 edi­tion and pro­vides for a risk-based approach in how bio­log­i­cal safe­ty is framed for med­ical devices.

Key changes (prac­ti­cal impact) are among others:

When does it become “oblig­a­tory” under the MDR?
As a reminder, the pub­li­ca­tion of an ISO stan­dard does not auto­mat­i­cal­ly give a pre­sump­tion of con­for­mi­ty under the med­ical devices reg­u­la­tion (MDR). For pre­sump­tion of con­for­mi­ty the text must be adopt­ed as an EN stan­dard and ref­er­enced in the Offi­cial Jour­nal of the EU (OJEU) as a har­monised stan­dard. Until (and unless) an EN/harmonised ref­er­ence appears in the OJEU, man­u­fac­tur­ers should treat ISO 10993-1:2025 as the new state-of-the-art guid­ance to inform dossiers, while being aware it is not yet an auto­mat­ic MDR har­monised standard. 

Rec­om­mend­ed actions for RA teams
Reg­u­la­to­ry teams should review their bio­log­i­cal eval­u­a­tion plans and device port­fo­lios and con­duct a gap analy­sis. Poten­tial­ly, sci­en­tif­ic ratio­nales should be pre­pared to explain lega­cy deci­sions against the 2025 frame­work at audits and submissions.

Source: ISO 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

MDR har­monised stan­dards update