Draft stan­dard on clin­i­cal eval­u­a­tion published

On Novem­ber 28, 2025, the Ger­man Insti­tute for Stan­dard­iza­tion (DIN) pub­lished the draft stan­dard on the clin­i­cal eval­u­a­tion of med­ical devices, ISO/ DIS 18969:2025.

It is a draft stan­dard and yet to be pub­lished on the ISO plat­form – also the stan­dard once pub­lished in its final ver­sion, still needs to go through the har­mo­niza­tion process.

Still, experts val­ue the stan­dard as an impor­tant step towards align­ment and har­mo­niza­tion in clin­i­cal eval­u­a­tion prac­tice. So far, only var­i­ous guid­ance doc­u­ments are avail­able, e.g. MEDDEV and MDCG.

Source: Pro-Liance Glob­al Solutions 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Prac­ti­cal PMCF strate­gies and plans
• mdi Europa expe­ri­ence on MDR tech­ni­cal doc­u­men­ta­tion reviews