Quality & Compliance
State-of-the-Art Assessments.
Demonstrate and leverage technical standards with solid evidence. We conduct systematic state-of-the-art assessments for medical devices—serving as an essential foundation for clinical evaluation, risk management, and MDR documentation.
How do medtech manufacturers assess the state of the art for their products under the MDR?
MDR Annex I requires that medical devices incorporate the current "state of the art." Failure to provide this documentation poses a high risk:
- The absence of, or outdated, state-of-the-art documentation is one of the most common findings identified by Notified Bodies.
- The state of the art is directly incorporated into risk acceptance decisions in accordance with ISO 14971. Without it, risk management is invalid.
- Clinical evaluations (CERs) that do not include current evidence on the state of the art are not MDR-compliant.
- Sources must be systematically researched and documented in a way that allows for verification—individual citations are not sufficient.
Can you provide evidence of the current state of the art for each of your products, including clear sources, guidelines, and references?
Our assessment services.
We provide well-founded, source-based, state-of-the-art assessments that stand up to any audit.
Literature & Standards Research
Systematic research: standards (ISO/IEC), guidelines (MDCG, FDA), scientific literature, and registries. All fully documented and traceable.
State-of-the-Art Report
Preparation of a structured report with a list of references and clear reasoning. Ready for use in technical documentation and the CER.
Integration into CER & Risk Management
Seamless integration of the findings into clinical evaluation reports (in accordance with MDR Annex XIV) and into risk acceptance decisions (in accordance with ISO 14971).
Periodic Update (PMS)
Ongoing updates to the status as part of your post-market surveillance (PMS) cycle. Ensuring ongoing regulatory compliance.
Frequently Asked Questions About State-of-the-Art Assessments.
What is the "state of the art" according to MDR?
The state of the art defines the level of technical capabilities at a given point in time, based on established knowledge. It serves as a benchmark for product safety and clinical performance.
What sources document the state of the art?
Harmonized standards (EN ISO), MDCG guidelines, scientific literature (PubMed), professional association guidelines, similar approved products, and clinical registry reports.
How often does the assessment need to be updated?
At a minimum, as part of the PMS cycle: annually for Class III devices, every two years for Class IIa/IIb devices, and whenever changes are made for Class I devices. New relevant ISO standards also often trigger an update.
How does this relate to clinical evaluation?
The SOTA serves as the direct input for the CER (MEDDEV 2.7/1 Rev. 4): It defines the performance standards a product must meet in order to be considered safe and effective.
Additional expertise in the area of Quality & Compliance.
Expertise
Risk Management
Risk management and acceptability assessment in accordance with ISO 14971 for medical devices.
ExpertiseMDR Consulting
Comprehensive support for certification under the Medical Device Regulation (EU) 2017/745.
ExpertisePost-Market Surveillance
PMS plans, PSUR preparation, and market data monitoring for approved products.
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