Medtech clinical evidence for clinical evaluation and post-market work
Find the trials and publications behind your clinical evaluation, state of the art and post-market literature work, with every sentence cited to an NCT number or PMID you can open and check.
Clinical evaluation work under EU MDR
Under the EU Medical Device Regulation (EU 2017/745), a manufacturer keeps a clinical evaluation up to date throughout the life of a device, as described in Article 61 and Annex XIV. The clinical evaluation report rests on a documented literature search: the current state of the art for the condition and alternative treatments, data on the device itself and, where equivalence is claimed, data on the equivalent device. Post-market clinical follow-up under Annex XIV Part B adds a recurring look at newly published literature and registered studies.
In the United States, submissions such as a 510(k), a De Novo request or a premarket approval application also draw on published clinical literature and registered studies, alongside the testing and data the FDA asks for in each pathway.
The hard part is volume and repetition. Regulatory and clinical affairs teams run the same searches again for every update, screen hundreds of abstracts, and must show where each statement in the report comes from.
- State of the art sections need current trials and publications, not last year's search
- Equivalence and similar device literature has to be traceable to its source
- PMCF literature reviews repeat on a schedule set in the PMCF plan
- Notified body reviewers expect every claim to point to a reference
A typical clinical evaluation literature workflow
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1. Ask a focused question, for example what randomized trials and cohort studies report on drug coated balloons in femoropopliteal artery disease.
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2. Read the cited answer. Each sentence links to the registry record or PubMed entry, and every citation is verified against the index before the answer appears.
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3. Open the trial table and filter by intervention, study type, date range, country and results available to separate device studies from drug studies.
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4. Build an evidence summary that labels the level of evidence for each cited source, from randomized trials to case series.
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5. Save the search and set an alert, so newly registered studies and publications reach the team between scheduled PMCF reviews.
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6. Export to DOCX with a reference list, or to RIS and BibTeX for your reference manager, and carry the citations into your own report template.
Features that matter for medtech evidence
- Cited answers where every sentence carries its source
- Evidence summaries and comparisons with the level of evidence per source
- Alerts on saved literature questions for post-market surveillance
- Export to CSV, XLSX, DOCX with reference list, RIS and BibTeX
- An AI literature review workflow that keeps the search traceable
ClinicalEvidence supports the literature part of your work. It does not write your clinical evaluation report, decide equivalence, or predict how a notified body or the FDA will assess a submission. Your qualified team stays responsible for appraisal and conclusions.
Recommended plan for medtech regulatory teams
Research Team costs 199 USD per month, or 99 USD per month billed yearly (1 188 USD). It gives 800 cited answers per month pooled across 3 seats, up to 100 per day, trial tables of up to 200 studies per answer, 25 alerts, DOCX export with a reference list and shared workspaces.
A manufacturer with several product lines and a need for an audit log chooses Organization at 499 USD per month, or 249 USD per month billed yearly (2 988 USD), with 2 000 cited answers pooled, 10 seats, 100 alerts and invoicing. Details are on the pricing page.
Questions from medtech teams
Can ClinicalEvidence replace the literature search protocol in my CER?
No. You still define and document your search protocol and appraisal method. ClinicalEvidence helps you find, read and cite relevant trials and publications faster, and every citation links to its source record.
Does it help with post-market clinical follow-up literature?
Yes. Save the questions from your PMCF plan and turn on alerts. New matching trials and publications arrive by email, and you can export them for your next review.
Does using ClinicalEvidence guarantee regulatory acceptance?
No. Regulatory outcomes depend on your full technical documentation and the assessment by the notified body or the FDA. ClinicalEvidence is a research tool for professionals.
Build your next clinical evaluation on cited evidence
Create your account and run your state of the art questions with sources on every sentence.