Eudamed Software

European Authorised Representatives and Importers…monitoring EUDAMED client activity?
Monthly checks on EUDAMED for client activity take time. Our EUDAMED Check service will provide you with PDFs of client SRN EUDAMED submissions, including monthly updates for any new additions you may be responsible for. EudaMed Check is keeping you up to date.

Importers check your manifest’s UDI DI is in EUDAMED and tie the search results to a specific manifest number. This will provide proof that you are meeting your legal obligations in checking EUDAMED for the existence of the specific DIs.

MedTech Manufacturers data registered in EUDAMED
Do you know what data you have in EUDAMED? You can’t easily download it for review. Our EUDAMED Check service will provide you with PDFs and JSON data of all your SRN EUDAMED submissions, including monthly updates for any new additions. Keep back ups, keep PDFs for proof of reviews, keep up to date on your SRNs EUDAMED activity.

Manufacturers Medical Device tenders are increasingly looking for you to prove your EUDAMED UDI DI submission requirements Do you need certified proof that your UDI DIs are in EUDAMED? Are you entering a new market and require proof that your UDI IDs are in EUDAMED? We provide you with a report certifying the requested UDI DIs are in EUDAMED. The report includes the specific EUDAMED UDI DIs in PDF format and a letter certifying their existence.

Manufacturers, are you sure all your UDI DI’s are in EUDAMED? Do you want to verify your new devices have been added? Identify missing UDI DIs. EudaMed Check can save you a lot of time and money by completing the task for you.

Competitor analysis required? Search for any manufacturer’s products using the SRN and receive downloads of all their UDI DI details.

EudaMed Check & Certify requires you to submit the following criteria which can include SRNs, Basic UDI(s), or a list of specific UDI DIs. Include a manifest ID, tender reference, or a specific company reference to keep the search results specific to a search.

We produce the certified results for the UDI DIs ready for you to download, and most importantly for the UDI DI specific searches, an exception report is produced detailing UDI DI’s missing from EUDAMED.

EUDAMED Check & Certify options:
Service

  • EUDAMED Check & Certify Service

Online Software Tool

  • Check SRN’s EUDAMED activity monthly – software tool

EudaMed Check & Certify…
 

“EudaMed Check” Free Demo Request

Protect Your EUDAMED Registrations from Fraud

As a medical device manufacturer, ensuring regulatory compliance is non-negotiable. The EudaMed Monitor is here to support your Person Responsible for Regulatory Compliance (PRRC) by automating critical EUDAMED checks. The system periodically checks EUDAMED and monitors for counterfeit devices, providing date-stamped reports confirming that the required periodic checks have been completed.

Key Features:

  • Periodic EUDAMED Checks: Prove compliance with recorded provable Periodic EUDAMED checks.

  • Automated Certificate Verification: Weekly scans to detect any fraudulent use of your registered certificates.

  • Counterfeit UDI Detection: Advanced algorithms identify potential counterfeits with over 70% accuracy, enabling swift action.

  • Time-Saving for PRRCs: Reduce the manual effort required for regular EUDAMED checks, freeing up your PRRC for other strategic tasks.

Benefits:

  • Enhanced Compliance: Stay ahead of regulatory requirements with proactive and periodic monitoring.

  • Brand Protection: Safeguard your reputation by swiftly addressing counterfeit threats.

  • Operational Efficiency: Streamline your compliance processes and focus on innovation.

Don’t leave your compliance to chance. Let EudaMed Monitor be your ally in navigating the complexities of EU medical device regulations.

Assessing manufacturer obligations

  • Manufacturers must establish a post-market surveillance system under Article 83 of the MDR. This involves checking data from sources like EUDAMED, even if it’s not fully operational yet.

MDR articles regulating falsified medical devices:

  • Article 2 (9) defines falsified devices,
  • Article 7 sets out prohibited false impression claims (i.e., claims that may suggest a product is a medical device when it is not),
  • Articles 13 and 14 give reporting obligations for importers and distributors for falsified devices, respectively; and
  • Article 93 gives competent authorities the right to take falsified devices off the market to protect public health.

To meet and act on the above articles, distributors, importers, manufacturers, and competent authorities must first locate the falsified devices, which is a slow, labour-intensive task. Our EudaMed Monitor weekly service will help your team effortlessly monitor EUDAMED and meet their EUDAMED post-market surveillance requirements.

EudaMed+ and EudaMed SaaS overview infographic.

  • Exceptionally cost-effective, this costs a fraction of the price to create your own system.
  • XML creation for Manual and Automated Upload to the European Commissions EUDAMED.
  • Created by people who helped guide the European Commission EUDAMED project.
  • Add/Edit your data to our spreadsheets, EudaMed SaaS validates and converts your data to EUDAMED read XML files.
  • View your validated spreadsheet data in easy to read PDF’s.
  • Reduce EUDAMED errors with full validation before your XML creation.
  • Your device data validated before EUDAMED receives the data.
  • Creates the required XML for you.
  • Easy to use and navigate.
  • Supported and maintained by us, the EUDAMED experts.
 

Best in class for validated XML creation, ready for you to upload to EUDAMED.
Don’t just take our word for how good this is, contact us for an online demo
 

EudaMed SaaS Demo Request

EudaMed+ and EudaMed SaaS overview infographic.

  • Exceptionally cost-effective, this costs a fraction of the price to create your own system.
  • Automated or Manual EUDAMED Submissions.
  • Safely manage your data on your or our managed servers.
  • Multiple SRN’s can use the same EudaMed+ install.
  • User-level security access control.
  • Created by people who helped guide the European Commission EUDAMED project.
  • Data management and upload options:
    • Full automated EUDAMED submission management.
    • Option for Machine to Machine data management.
    • XML preparation for automated or manual for EUDAMED uploads.
  • Add/Edit your data using user-friendly forms similar to EUDAMED.
  • Full version control and record locking options.
  • Validation and data upload reporting.
  • Reduce the time to add and collate data with useful clone DI functionality.
  • Reduce EUDAMED errors with full validation before your XML creation.
  • Your device data validated on your servers before EUDAMED receives the data.
  • Creates the required XML for you.
  • Easy to use and navigate EudaMed+
  • Supported and maintained by us, the EUDAMED experts.

Best in class Automated, Machine to Machine, or Bulk upload XML validation, preparation, and EUDAMED submission system.
Don’t just take our word for how good this is, come talk to us about your needs
Book a free introductory meeting to discuss your EUDAMED needs.