ISO 18969 (Draft): New international guarding rails for the clinical evaluation of medical devices
The clinical evaluation of medical devices is becoming clearer and methodologically more tangible.
With the draft of ISO 18969, a dedicated international standard is available for the first time, systematically describing the clinical evaluation process across the entire product life cycle. The draft provides structure in the interaction of MDR requirements, MEDDEV principles and MDCG guidance, reinforces the role of the state of the art and offers manufacturers a robust methodological framework within the European regulatory context.
With the draft standard ISO 18969 “Clinical evaluation of medical devices” a standalone international standard is introduced for the first time, comprehensively defining the entire clinical evaluation process for medical devices. While the European Medical Device Regulation (MDR) sets high requirements on clinical evidence, it has so far largely relied on guidance documents and interpretative frameworks.
The standard is currently in the draft stage (ISO/DIS 18969:2025 / prEN ISO 18969:2025) and was published in November 2025. The public commenting phase ran until the end of January 2026 Following completion of the standardisation process, adoption as a harmonised European standard is anticipated, potentially conferring a presumption of conformity with key MDR requirements.
What does ISO 18969 cover?
ISO 18969 establishes principles, procedures and methodological requirements for the clinical evaluation of medical devices throughout their entire life cycle. Its objective is to generate and assess robust clinical evidence regarding safety, clinical performance and/ or medical efficacy, clinical benefit and the overall benefit-risk profile of a device.
The standard provides detailed guidance on:
- the planning of the clinical evaluation,
- the identification, evaluation and analysis of clinical and non-clinical data,
- the overall assessment, taking into account all relevant information,
- and the continuous updating of the clinical evaluation in the post-market phase.
A central guiding principle is to shift away from a static, point-in-time approach towards an iterative, lifecycle-oriented process that is closely integrated with device development, risk management, clinical development and post-market surveillance.
Driving standardisation body and strategic context
The standard was developed by ISO/TC 194 “Biological and clinical evaluation of medical devices” in close collaboration with CEN/TC 206, with the secretariat provided by DIN (Germany). This committee is also responsible for well-established standards such as ISO 10993 and ISO 14155 and represents for a strong link between clinical science, regulatory requirements and standardisation.
From the perspective of view of the ISO/TC 194 standardisation committee, there has so far been no internationally harmonised standard that describes clinical evaluation as a scientifically robust, lifecycle-oriented end-to-end process. The primary objective of the standard is therefore to standardise methodology, rather than to tighten regulatory requirements.
For the EU, ISO 18969 addresses the significant degree of interpretation inherent in MDR requirements, particularly with regard to the state of the art (SOTA), data weighting and benefit-risk assessment. It further specifies existing requirements without creating new legal obligations, thereby establishing a more consistent and objective basis for evaluation for both manufacturers and notified bodies. As such, the standard represents a key instrument for stabilising and professionalising clinical evaluation within the MDR context, while ensuring strong alignment with international practices.
Clinical evaluation to date: MEDDEV and MDCG
Historically, clinical evaluation in Europe was primarily based on MEDDEV 2.7/1 Rev. 4 from 2016. When the MDR came into force, these guidelines were formally replaced, but their content was partly continued by MDCG guidance documents. In the absence of alternative formal requirements, MEDDEV was still referred to in practice and the structure of the clinical evaluation is still based on these recommendations today.
MEDDEV and MDCG are characterised by their non-normative nature. They provide valuable interpretation aids, but leave room for manoeuvre in terms of methodology, depth and weighting of clinical evidence. An internationally harmonised, bindingly structured standard has been lacking until now – this is precisely where ISO 18969 comes in.
Innovations and added value of ISO 18969
The added value of ISO 18969 lies less in introducing entirely new regulatory requirements and more in providing a clear methodological framework:
- Lifecycle approach
Clinical evaluation is explicitly defined as a continuous process, with objectives that evolve depending on the respective stage of the product lifecycle.
- Balanced consideration of clinical and non-clinical data
In addition to traditional clinical investigations, the standard systematically incorporates preclinical data, real-world data, post-market surveillance (PMS) data, as well as digital evidence (e.g., in silico models, AI-based analyses).
- Transparent evaluation and weighting of data
The standard requires defined criteria for assessing relevance, quality and significance – including the disclosure of limitations.
- Stronger integration into QMS and risk management
Clinical evaluation is clearly positioned as an integral component of both the quality management system and the risk management process.
State of the Art (SOTA) as an explicit focus – Implications for the EU
A particular highlight is the explicit and central role of the state of the art (SOTA). SOTA is defined as part of the “available knowledge” and serves as a reference framework for:
- defining clinical endpoints,
- establishing evaluation criteria,
- contextualising clinical benefits,
- conducting risk-benefit assessment in comparison with alternatives.
Importantly, SOTA is not equated with the most technically advanced solution, but rather with the generally accepted standard of good medical and technical practice. This clarification is highly relevant for the EU context, as it provides an objective, comparative basis for justification – particularly in interactions with notified bodies.
The strong emphasis on SOTA clearly reflects the approach of the standardisation committee: in future, clinical evaluation should be even more comparative, evidence-based and transparent.
Conclusion – ISO 18969: Methodological clarity for clinical evaluation
ISO 18969 is more than just another guidance document. It establishes an internationally harmonised, methodologically stringent regulatory framework for the clinical evaluation of medical devices. For the EU and the MDR, it provides an much -needed clarification of existing requirements – particularly regarding SOTA, lifecycle thinking and the benefit-risk justification.
For manufacturers, the methodological requirements are increasing, while at the same time regulatory clarity and predictability are simultaneously enhanced. ISO 18969 thus has the potential to become a new reference standard for clinical evaluation in both the European and international context.
