What a clinical evaluation report needs from software
Under the EU MDR the manufacturer keeps a clinical evaluation current across the device life cycle. The work splits into stages, and each stage wants a different kind of tool.
- Literature search. A documented protocol, defined databases, search strings and dates, so a notified body can reproduce it.
- Screening and appraisal. Inclusion and exclusion decisions, often by two reviewers, with a log of reasons.
- Evidence extraction. Study design, population, device or comparator, outcomes and safety events in tables.
- State of the art. What alternative treatments and competing devices achieve today, with sources.
- Surveillance. New publications and trials after release, which feed PMCF and the periodic update.
- Writing and traceability. Every statement in the report traced to a source.
Software marketed as CER software often handles only the last stage. The search, extraction and state of the art stages are where most hours go.
Tool types compared by task
Product categories are described from general knowledge of the market. Check each vendor for current features and prices.
| Tool type | Best at | Weak spot |
|---|---|---|
| ClinicalEvidence | Cited answers from PubMed, ClinicalTrials.gov, EU CTR and WHO ICTRP, a filterable trial table, alerts, RIS and BibTeX export | Does not search Embase, no dual reviewer screening workflow |
| Systematic review platforms (Covidence, DistillerSR and similar) | Dual screening, conflict resolution, audit trail of exclusions | You still need the search and a place to read studies quickly |
| Reference managers | Storing and deduplicating references, citing in a document | No search or synthesis |
| General chatbots | Fast drafting of text | Can invent citations, which a notified body will find |
| Regulatory writing consultancies | Full report delivery and notified body experience | Cost and turnaround, little control for in house teams |
Most teams end up with two tools. A registry and literature tool for the first pass, state of the art and surveillance, and a screening platform when the protocol demands formal dual review.
Where a cited registry tool saves the most time
Three tasks repay a tool like ClinicalEvidence quickly.
- State of the art. Ask what outcomes alternative treatments report for the condition and get a cited summary plus a table of the trials behind it. Open each source and appraise it before it enters the report.
- Competing and similar device trials. The trial table lists design, endpoints, status, sponsor and countries from three registries, which helps when you document what is ongoing.
- PMCF surveillance. A saved question with alerts flags new trials and status changes between periodic updates.
Evidence rows export to RIS and BibTeX and to CSV, so references land in the manager your team already uses. See also the medtech clinical evidence page for how teams run this work.
What it does not do, and how to cover the gap
ClinicalEvidence searches PubMed and trial registries. If your search protocol names Embase, Cochrane or a device database, run those searches there and import the results next to the PubMed export. It does not replace dual screening: for a formal protocol, take the search and the extraction table here and run the screening in your review platform. Verification shows that a reference exists and supports the sentence, and your evaluator still appraises study quality and relevance. Read why AI invents citations before you trust any generic chatbot with this work.
Equivalence claims and manufacturer files add one more input: technical documentation, IFUs and test reports sit in PDFs. When you need to check a specific claim across those, a tool to ask questions of your own technical documents answers from the files directly, and you then cite the source file in the report.
A workable setup for a three person regulatory team
Write the protocol first: device, indication, comparators, databases and dates. Run the PubMed and registry part in ClinicalEvidence as saved questions, export the trial table and RIS file, and add Embase results from the other database. Screen in the review platform if the protocol requires it. Draft the state of the art from cited answers and keep one evidence table per section. Turn on alerts so the next periodic update starts from a list of what changed. Research Team gives all three people one pool of 800 answers at 99 USD per month billed yearly, see pricing. A single evaluator can start on Clinician.
Questions regulatory teams ask
What is the best software for a clinical evaluation report?
No single tool covers a whole clinical evaluation report. Teams combine a literature and registry search tool, a screening tool if the protocol demands dual review, and a writing environment. ClinicalEvidence covers the search and evidence table part for PubMed and trial registries, with a citation behind every sentence.
Can AI write a clinical evaluation report?
AI can speed up literature search, evidence tables and first drafts, but the manufacturer owns the conclusions and a notified body reviews them. Every claim needs a source an appraiser can open, so use tools that cite each sentence and keep the clinical judgment with a qualified evaluator.
Does ClinicalEvidence replace Embase for MDR literature searches?
No. ClinicalEvidence searches PubMed and the ClinicalTrials.gov, EU CTR and WHO ICTRP registries. If your literature search protocol names Embase or other databases, run those searches there and use ClinicalEvidence for the PubMed and registry parts, exports to RIS and BibTeX included.
Can I use it for PMCF and state of the art reviews?
Yes. Saved questions with alerts flag new trials and status changes between updates, which helps with PMCF literature surveillance. For a state of the art section, use cited answers and the trial table, then appraise each study against your protocol.
How much does it cost for a regulatory team?
Research Team is 199 USD per month or 99 USD per month billed yearly for 3 seats and 800 pooled answers. Organization is 499 USD per month or 249 USD per month billed yearly for 10 seats, an audit log and invoicing.