State of the Art Reviews for Medical Device and IVD Manufacturers
Pubrica writes state of the art reviews for medical device and IVD manufacturers preparing or updating a clinical evaluation. The state of the art is the benchmark a notified body uses to assess your device: what current alternatives achieve, which risks are accepted in the indication and what a clinician would reasonably use instead. An inadequate state of the art is one of the most common deficiencies raised against a CER. Our device clinical evaluation writers deliver a systematically searched, reproducible review with acceptability criteria derived for your clinical evaluation, and update it on your CER cycle.
- Written as the benchmark for the clinical evaluation, defining acceptable performance and acceptable risk for the indication
- Written to MEDDEV 2.7/1 rev 4 and MDR Annex XIV Part A, which set out the requirement
- All alternatives and benchmark devices identified, including those that outperform your device, because a notified body will find them
- Searched systematically and recorded, so the assessor can reproduce the search and verify the conclusion
- Updated on your CER cycle, because the state of the art changes and an outdated benchmark no longer reflects current practice
Benchmark for the indication establishedIncluded
Alternatives and comparators identifiedIncluded
Systematic, recorded searchIncluded
Acceptability criteria derivedIncluded
Omitting a better-performing alternativeNot offered
Indication → alternatives → benchmark → criteria → CER
- Written as a benchmark for the indication
- MEDDEV 2.7/1 rev 4 structure
- Search recorded and reproducible
- Better-performing alternatives included
- Updated on the CER cycle
Deliverables
Four Core Elements of Every State of the Art Review
A state of the art review uses systematic review methods, but its purpose is to set the benchmark for a regulatory clinical evaluation.
Example from a state of the art reviewWithout derived acceptability criteria, the clinical evaluation has no basis for comparing its data, and a notified body will raise this. It is among the most frequent CER deficiencies.
Example from an alternatives sectionOmitting a better-performing alternative is likely to lead to a finding of bias in the clinical evaluation, because the assessor searches the same literature.
Example from a methods sectionState of the art sections built from a few references and a narrative are the ones most likely to receive a deficiency letter.
Example from a project handoverClinical evaluation is a lifecycle obligation under MDR. A state of the art review that cannot be extended must be redone at each cycle.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Regulatory and Methodological Standards for State of the Art Reviews
The requirement is set by regulation, and the method follows evidence synthesis practice.
Medical Device Regulation (Article 61, Annex XIV Part A)
Requires clinical evaluation to be based on a critical evaluation of the relevant scientific literature on the safety, performance, design characteristics and intended purpose of the device, which is where the state of the art obligation originates.
Clinical evaluation guidance (June 2016, with MDCG 2020-13)
The structure notified bodies still assess against, including how the state of the art is established and how acceptability criteria are derived from it. MDCG 2020-13 is the assessment template assessors use.
PRISMA 2020 (review reporting)
The reporting standard for systematic reviews, covering the flow of records, search reproducibility and the reasons for excluding each study at full text.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our quality management system governs how each project is run, recorded and released.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to its evidence and to a named individual. For this reason, source traceability takes priority over speed in our regulatory writing, and every statement must be traceable to its source.
Why We Do Not Publish an AI Accuracy Figure
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How Our State of the Art Review Writing Process Works
We define the indication first, because the state of the art is defined for an indication rather than for a device.
Indication and Scope
We define the intended purpose and indication precisely, since the benchmark applies to that indication rather than to your technology.
Literature Search and Study Selection
We search the literature, guidelines, standards and registries systematically, recording each source with dates and counts.
Clinical Benchmark Definition
We characterise current alternatives, establish accepted performance and accepted risk, and include non-device management where it is a realistic option.
Acceptability Criteria Derivation and CER Handover
We derive acceptability criteria explicitly from the benchmark, write them into the CER and preserve the search so that the next cycle can extend it.
Our Experts
Your State of the Art Review Team
A named team of regulatory specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. Each expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
State of the Art Review Service Packages
Pricing depends on the indication, the number of alternatives and whether an earlier review can be extended.
State of the art review
For a device clinical evaluation
Quoted per projectBased on indication and number of alternatives
Delivery By scope
- ✓Indication and intended purpose fixed
- ✓Systematic search recorded per source
- ✓Alternatives characterised, including better ones
- ✓Benchmark established for the indication
- ✓Acceptability criteria derived explicitly
- ✓Written into the CER structure
We recommend commissioning the review separately from the CER where the benchmark is contested or the indication is broad.
Deliverables Request a quoteState of the Art Review with Clinical Evaluation
For a full CER project
Quoted per projectBased on device class and evidence
Delivery By scope
- ✓State of the art review as the foundation
- ✓Clinical evaluation built against its criteria
- ✓MDCG 2020-13 structure throughout
- ✓Literature appraisal to a stated method
- ✓PMCF gaps identified against the benchmark
Commissioning both together is usually more cost-effective, because the searches overlap and the criteria must be consistent across both.
Deliverables Request a quoteState of the Art Review Update
For an existing review at its next cycle
Quoted per projectBased on elapsed time and new evidence
Delivery By scope
- ✓Search rerun against the recorded strategy
- ✓New alternatives and new evidence added
- ✓Benchmark movement identified
- ✓Acceptability criteria revised where it moved
- ✓CER impact assessed
An update is possible only where the original search was recorded. Otherwise, a new review is required, and we will tell you so.
Deliverables Request a quoteSend the indication and we will identify the current alternatives at no cost, so you can see the benchmark your device will be assessed against before commissioning a review.
FAQs
State of the Art Review FAQs
If your question is not answered here, ask an expert. No quote is required.
The method is similar, but the purpose differs. A literature review summarises a field, whereas a state of the art review establishes the benchmark your device is judged against and derives the acceptability criteria from it.
A state of the art section that reads as background rather than as a benchmark is one of the most common CER deficiencies raised by notified bodies.
Yes. The state of the art is the current standard for the indication, regardless of how your device compares with it. Omitting a better-performing alternative is not a defensible scope decision.
The assessor searches the same literature, and an omission of this kind affects how the rest of the evaluation is read.
It requires a search an assessor can reproduce, which in practice means a recorded strategy for each source, with dates, counts and a documented study selection.
Narrative sections built from a few selected references are the ones most likely to receive deficiency letters.
On your clinical evaluation cycle, because clinical evaluation under MDR is a lifecycle obligation rather than a one-off submission.
If the original search was recorded properly, an update extends it. If it was not, the review must be redone, which adds cost at every cycle.
Related Services
Related Regulatory Writing Services
The state of the art review is the foundation of a device clinical evaluation.
1CLINICAL EVALUATIONdownstream
Clinical evaluation reportAssessed against this benchmark. Performance evaluation reportThe IVDR equivalent.2TECHNICAL FILE DOCUMENTSalongside
Technical file & 510(k)EU and US submissions. Risk management planRecords accepted risk.3METHODOLOGYsystematic review methods
Systematic reviewThe search and screening method. Search peer reviewPRESS review before the search runs.Request a Free Review of Current Alternatives for Your Indication
You will see the benchmark your device will be assessed against before you commission a review.