The state of the art refers to the current stage of development of technical capabilities and recognized clinical practice, based on established knowledge from science, technology, and experience. In medical device law, it forms the reference framework for assessing whether a product’s safety, performance, and benefit-risk ratio have been adequately evaluated. It changes when new reliable findings shift recognized practice.
Content of the Assessment Standard
This standard connects technical capabilities with care practice. It includes relevant norms, guidelines, knowledge about the disease, available treatment alternatives, and robust clinical data on comparable products. Therefore, for a specific intended purpose, it is necessary to clarify which risks and treatment outcomes are currently considered acceptable.
The clinical evaluation does not have to incorporate every published innovation. However, it should capture the state of medical knowledge in such a way that safety and performance requirements are not assessed against an outdated comparative horizon. For rapidly developing technologies, this horizon can shift significantly faster than for established care procedures.
Function in Clinical Evaluation
The Clinical Evaluation Plan defines qualitative and quantitative parameters for assessing the acceptability of the benefit-risk ratio. The state of the art provides the context for this: it reveals which undesirable effects, success rates, or alternatives must be considered for the intended indication. The evaluation can also document differing professional opinions if the evidence does not support a uniform practice.
For legacy devices, this comparison is particularly important. Historical data do not automatically prove that a product meets current expectations. If new clinical data are needed, post-market surveillance or a PMCF study can close gaps that have only become apparent due to a changed care situation.
The search for the state of the art is not concluded with a one-time literature review. It must cover the relevant disease, the target group, and the specific medical intended purpose of the product. For a diagnostic system, for example, available reference methods, the consequences of false-positive or false-negative results, and current standard care belong within the scope of consideration.
To ensure the standard remains verifiable, the search strategy, selection of sources, and justification for excluded alternatives should be traceable in the clinical evaluation file. A mere list of new publications does not yet show whether these findings alter the accepted limits or the benefit-risk assessment of one’s own product.
Special attention should be paid to the language of the intended purpose. A comparison with a therapy that is technically similar but addresses a different patient group or clinical goal can distort the standard. The state of the art must therefore always be formulated in relation to the specific clinical question.
Distinction from the Latest Technology
State of the art does not mean that the technically most modern solution is always required. What is generally recognized as good practice in technology and medicine is decisive. A very new method may still be insufficiently validated or too little widespread to achieve this status.
Conversely, a long-known procedure can lose its reference character if robust data or changed treatment pathways supersede its evaluation. The term is therefore not an innovation ranking. It is an evidence-based comparative standard that reflects both stability and professionally justified change.
Relevance for clinical trials
When planning a clinical investigation, the state of the art influences the choice of comparator treatment, endpoints, inclusion criteria, and follow-up. An investigation plan must be able to explain why the chosen comparison reflects current care and how relevant alternatives have been considered. In monitoring scientific literature, a new guideline or changed risk knowledge may necessitate an update of the clinical development plan.
Full-service CROs like Mediconomics support the structured research of guidelines, comparator therapies, and clinical benchmarks, as well as the transfer of these findings into the Clinical Evaluation Plan, investigation plan, and statistical endpoint definition. They document the source basis of the medical evaluation and coordinate the updating of risk analysis, Clinical Evaluation Report, and PMCF plan when care practice shifts.
Frequently Asked Questions (FAQ)
Is a harmonized standard alone the state of the art?
A standard can be an important indicator, but it does not exhaust the term. Clinical practice, available alternatives, and current scientific knowledge also belong to the evaluation.
Must a product be better than every available alternative?
The standard requires a justified benefit-risk assessment in light of recognized practice. It does not imply that the product must be superior in every performance characteristic.
How often must the state of the art be reviewed?
The relevant guidelines require planned observation of scientific and medical developments. The appropriate rhythm therefore depends on the product, indication, and dynamics of the specialty.
Regulatory References
- Regulation (EU) 2017/745, Annex I Chapter I Number 1 – links risks to the generally acknowledged state of the art.
- Regulation (EU) 2017/745, Annex XIV Part A Number 1 – requires the evaluation of the benefit-risk ratio in the medical context.
- MDCG 2020-6 – describes the role of the standard in clinical evidence for legacy devices.
- MDCG 2022-2 – transfers the continuous observation of the standard to the performance evaluation of IVDs.