EU MDR post-market reports
A documented literature and vigilance-data search for your EU MDR report.
Artifakt Vigilance runs a PRISMA / MEDDEV 2.7/1 literature search from a user-defined protocol and aggregates public vigilance and clinical-evidence data - FDA MAUDE, FDA Recalls, BfArM, MHRA, Health Canada, PubMed, Europe PMC and ClinicalTrials.gov - then drafts it into the sections of your PSUR, PMCF evaluation, SSCP or standalone literature review.
Free during launch - no approval needed
Data sources
Eight safety databases, one search.
FDA MAUDE
Adverse event reports submitted to the US FDA for medical devices, including manufacturer, user facility, and voluntary reports.
FDA Recalls
Database of device recalls, market withdrawals, and field safety corrective actions issued by the US FDA.
BfArM (Germany)
Field safety corrective actions and vigilance notices from the German Federal Institute for Drugs and Medical Devices.
MHRA (UK)
Medical device alerts, field safety notices, and manufacturer corrective actions from the UK regulator.
Health Canada
Medical-device recalls, field safety corrective actions and safety alerts from Health Canada's Recalls and Safety Alerts database.
PubMed
Biomedical literature from NCBI - clinical studies, case reports, systematic reviews relevant to device safety.
Europe PMC
European-focused open-access scientific literature, complementing PubMed with additional EU publications.
ClinicalTrials.gov
Registry of clinical studies for PMCF monitoring - track ongoing and completed device trials worldwide.
Free quick search - no signup needed
One free query across FDA MAUDE, FDA Recalls, BfArM, MHRA, Health Canada, PubMed, Europe PMC and ClinicalTrials.gov - a fast read of the safety landscape, no account required. The report workspace above runs its own auditable, frozen search for the evidence base.
Why monitor
EU MDR makes vigilance monitoring mandatory.
Under EU MDR 2017/745, manufacturers must proactively gather safety data from adverse-event databases, recall notifications, scientific literature, clinical-trial registries and national competent-authority alerts. These searches directly support PMS Reports (Art. 85), PSURs (Art. 86), and the ongoing risk-management file.
MDCG 2022-21 then prescribes the PSUR's exact structure - and notified bodies expect the data to come from named sources. Doing that manually means logging into five portals, exporting CSVs, deduplicating by hand, and writing prose around the numbers.
- 01FDA MAUDE adverse event reports for equivalent devices
- 02Recall databases covering field safety corrective actions
- 03National competent authority alerts - BfArM, MHRA, Health Canada
- 04Scientific literature - PubMed, Europe PMC - for clinical evidence
- 05ClinicalTrials.gov for PMCF and equivalence evidence
Without systematic surveillance across all of these categories, manufacturers risk non-compliance during notified-body audits and competent-authority inspections - and miss safety signals while they are still small enough to act on.
FAQ
Common questions.
Is Artifakt Vigilance free?
Yes - the Quick search and the documented literature-report generator are free during launch, with a per-day search allowance. No card is required to start.
Which databases does Artifakt Vigilance search?
One search covers FDA MAUDE, FDA Recalls, BfArM (Germany), MHRA (UK), Health Canada, EUDAMED, PubMed, Europe PMC and ClinicalTrials.gov - adverse events, recalls, field safety notices and clinical literature.
Can it draft a PSUR, PMCF evaluation or CER literature review?
Yes. From a user-defined protocol it runs a documented PRISMA 2020 / MEDDEV 2.7/1 Rev 4 literature search and drafts the literature and vigilance sections of your PSUR (MDCG 2022-21), PMCF evaluation report, SSCP or standalone literature review - keeping the raw sources alongside for verification.
Is the literature search documented and auditable?
Yes. The protocol is frozen before screening, every source and its hit count is recorded, and the PRISMA 2020 flow plus the raw records are kept alongside the drafted report - so the search is reproducible and defensible in a notified-body audit.
Where is my data processed?
In the EU. Application hosting and AI inference stay within EU regions, and the tool is built for GDPR compliance and EU MDR post-market surveillance workflows.
Start with a free account.
Create an account and run your first report draft today - free while we onboard our first cohort of medical device manufacturers. No approval step, no card.