How do medical device manufacturers demonstrate the state of the art for their products under the MDR on a source-based, traceable basis?
We conduct source-based state-of-the-art assessments for medical devices: as the foundation for the clinical evaluation under MDR (EU) 2017/745 Annex XIV, for risk acceptability under ISO 14971, and for the technical documentation. The real risk is not the absence of a search, but a search that is not documented reproducibly: the notified body objects less to the conclusion than to the lack of traceability in how it was reached.
- MedTech
- IVD
Overview
Why is the state of the art critical for MDR manufacturers?
Source-based assessments for clinical evaluation and risk management · MDR (EU) 2017/745, ISO 14971, MEDDEV 2.7/1 Rev. 4
Last updated: 2026-06-13
MDR (EU) 2017/745 requires in Annex I that medical devices take account of the generally acknowledged state of the art. The state of the art is therefore not a background chapter but the benchmark against which safety and performance are measured. Three points at which it feeds in directly:
- The clinical evaluation under Annex XIV relies on the state of the art as its reference: without current evidence on what comparable devices and established procedures achieve, the benchmark for the evaluation is missing; a clinical evaluation without this reference is not MDR-compliant.
- Risk acceptability under ISO 14971 requires residual risks to be weighed against the state of the art. What counts as acceptable shifts as technical and clinical knowledge advances; an outdated evaluation will not withstand the risk assessment.
- The search must be systematic and reproducible, not anecdotal. Missing or outdated state-of-the-art documentation is a recurring finding at notified bodies, because the selection of sources cannot be traced.
- The state of the art is a moving target: new harmonised standards, MDCG guidance and clinical evidence change it continuously, which is why the assessment must be kept current as part of post-market surveillance.
Services
How we support you
Literature & standards search
Systematic, reproducibly documented search for the current state of the art: harmonised standards (ISO, IEC, EN), guidance documents (MDCG, EMA, FDA), scientific literature and database analyses. The deliverable is a traceable search protocol with the search strategy, inclusion and exclusion criteria, and a complete list of sources.
State-of-the-art report
Structured state-of-the-art report with a reference list, an appraisal of source quality, and traceable reasoning. Directly usable as a building block of the technical documentation and the clinical evaluation.
Integration into clinical evaluation & risk management
Integration of the results into the Clinical Evaluation Report under MDR Annex XIV and into the risk acceptability decisions under ISO 14971, with a documented link between the state-of-the-art statement and the specific risk and evidence appraisal.
Learn more →Periodic updates within the PMS cycle
Event-driven and scheduled updates of the state-of-the-art status as part of post-market surveillance: new standards, MDCG guidance and scientific evidence are appraised and the report is updated under version control, so that the technical documentation stays current.
Learn more →How we work together
What it comes down to
Under the MDR (EU) 2017/745, the state of the art is not a standalone mandatory document but a point of reference that is needed in several places at once: the clinical evaluation under Annex XIV measures the device's performance against it, risk acceptability under ISO 14971 weighs residual risks against it, and the technical documentation uses it to demonstrate the General Safety and Performance Requirements from Annex I. This implies a sequence: the reproducibly researched state of the art comes first, and only then can the clinical evaluation and risk acceptability be built on top of it. Anyone who reverses the order and goes looking for the state of the art after the fact, to fit a finished evaluation, creates a line of reasoning that falls apart in the audit as soon as the selection of sources is questioned.
The real linchpin is therefore rarely the conclusion, but the traceability. A search strategy with documented databases, search terms and inclusion and exclusion criteria turns a collection of well-known publications into an auditable search, and it is precisely this auditability that the notified body requires. Because new standards, MDCG guidance and clinical evidence shift the state of the art continuously, the update belongs in the PMS cycle: a report written once and never placed under version control goes out of date and drags the clinical evaluation into the finding with it. We set up the search strategy first, then the report, and anchor both so that every later update can be carried forward along the same documented path.
Our approach
Our approach
Step
Result
Scope & research question
Defined scope of assessment per device: indication, comparator procedures and the questions the state-of-the-art report must answer.
Define the search strategy
Documented search strategy with databases, search terms and inclusion and exclusion criteria as the basis for reproducibility.
Search & source appraisal
Reviewed standards, guidance documents and literature with appraised source quality and a logged record of the selected hits.
State-of-the-art report
Structured report with a reference list and traceable reasoning, usable in the technical documentation and the clinical evaluation.
Integration
Linking the report to the clinical evaluation under Annex XIV and to risk acceptability under ISO 14971.
Updates within the PMS cycle
Version-controlled updating of the report when new evidence, new standards or MDCG guidance appear.
Common pitfalls
Where projects commonly fail
The search is not reproducible.
Without a documented search strategy, named databases and inclusion/exclusion criteria, it is impossible to trace how the sources were selected; the notified body then objects not to the conclusion, but to the missing path that led to it.
The state of the art is written once and never updated.
New harmonised standards, MDCG guidance or clinical evidence shift the benchmark; a report with no link to the PMS cycle goes out of date and drags the clinical evaluation into the finding with it.
The state of the art stays disconnected from risk acceptability.
ISO 14971 requires residual risks to be weighed against the state of the art; if the documented link between the state-of-the-art statement and the risk decision is missing, the acceptability rationale is left hanging.
Anecdotal sources stand in for the systematic search.
A few well-known publications or experiential knowledge are not a systematic capture of the state of the art within the meaning of Annex I and MEDDEV 2.7/1 Rev. 4; the gap surfaces in the audit at the latest.
Source quality is not appraised.
A reference list alone is not enough: without classifying the level of evidence and the relevance of each source, it remains unclear how much weight a statement carries for the evaluation.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR) - primary text, Annex I, Annex XIV
- ISO 14971 - Application of risk management to medical devices
- MEDDEV 2.7/1 Rev. 4 - Guidance on clinical evaluation
- https://theentourage.de/expertise/state-of-the-art-assessments/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- Regulation (EU) 2017/745 (MDR)
- MDR Annex I (General Safety and Performance Requirements, GSPR)
- MDR Annex XIV (Clinical Evaluation & PMCF)
- ISO 14971 (Application of risk management to medical devices)
- MEDDEV 2.7/1 Rev. 4 (Guidance on clinical evaluation)
- MDCG guidance documents (Medical Device Coordination Group)
Related topics
MDR Consulting →
Overall MDR conformity under EU 2017/745, into which the state of the art feeds
Risk Management →
Risk acceptability weighed against the state of the art under ISO 14971
Post-Market Surveillance →
Literature search and updating of the state of the art within the PMS cycle
Clinical Compliance →
Clinical evaluation and PMCF under MDR Annex XIV
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