A new specification slated for publishing in Q1 of 2026 could signal a transformative shift in how technical documentation for medical devices is generated, managed and assessed throughout the EU. DIN SPEC 91509 Release #1 puts forth a standardised data model for technical documentation.
This upcoming effort has been brought to fruition by non-profit organisation Medical Device Knowledge Units (MDKU) e.V., and shows a clear reaction to the increased complexity under the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), where conventional documentation-orientated methods have become disjointed, cumbersome and present an increased risk of nonconformance. DIN SPEC 91509 seeks to define a common regulatory language, with a structured information and data model and clearly defined categories that reflect EU MDR Annex II and III requirements. This new structure intends to facilitate machine-readable content which can be interoperable and reusable among all stakeholders, from manufacturers to notified bodies and beyond.
From a strategic point of view, this latest development demonstrates the industry’s increasing openness toward regulatory processes becoming digital by design. By embedding a singular and transparent stream of information, it becomes far simpler to demonstrate clear traceability between regulatory requirements and evidence of conformity. Additional positive ramifications include a reduction in administrative burden, accelerated digital transformation and an increased ability to predict and anticipate conformity assessment practices.
However, further discussion remains to be had on how exactly DIN SPEC will be integrated with evolving EU regulatory frameworks and whether it is possible to successfully harmonise or reference this specification formally in upcoming MDR and IVDR guidance. For professionals navigating regulatory compliance, DIN SPEC 91509 represents a promising attempt at defining a blueprint for generating documentation which is more efficient and data-driven in the near future.
