ISO/DIS 18969 is a new draft international standard that introduces a structured, process-based approach to the clinical evaluation of medical devices across the product lifecycle, integrated with other key processes starting as early as product development. Its release comes alongside proposed revisions to the EU Medical Device Regulation that affect how clinical evidence is defined, assessed, and maintained.

Danielle Giroud and Maria E. Donawa, MD—both closely involved in the development of ISO/DIS 18969— explained the background and intent of the standard and the challenges it is designed to address in a Webinar held on 17 February 2026. They discussed how the lifecycle framework set out in the draft aligns with current and proposed MDR expectations, with a focus on clinical evaluation planning, evidence appraisal, benefit-risk justification, and practical considerations for manufacturers preparing for conformity assessment in Europe and beyond.

If its approach is implemented, ISO 18969 could significantly improve how companies manage clinical data needs across the product lifecycle.

The webinar was hosted by MedTech Leading Voice, with further details available from here.