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EudaMed Connect

What Is EudaMed Connect?

  • EudaMed Connect, our

    MDR Software Solution

    , is designed to allow you meet your compliance obligations under the European Commission Medical Devices Regulation (MDR).
  • If you are a pharmaceutical wholesaler, importer, hospital or health care institution then the Medical Devices Regulation (2017/745/ EU) (MDR) and (2017/746/EU) (IVDR) could be applicable to you.
  • The Class III Medical Devices EU regulation and obligations came into effect on 26 May 2021 and a staggered period is in place until 2025.
  • EudaMed Connect provides the ability to scan incoming serialised Medical Devices that includes a UDI (Unique Device Identifier) and provide additional device information when connected to the EU EudaMed database.

What Type Of Organisation Is EudaMed Connect Suitable For ?

  • Wholesalers
  • Importers
  • Distributors
  • Hospitals
  • Healthcare Institutions
  • No matter what the size of your organisation, EudaMed Connect can help.

Features & Benefits

  • Stand alone Windows application, so no need to upgrade your current ERP system
  • Easy to install
  • User friendly interface
  • Cost effective
  • Expiry date check
  • Connection to EU EudaMed database
  • Facilitates both online and offline scanning
  • Scan Incoming Serialised Medical Devices
  • Full transactional history
  • Highly configurable and customisable
  • Fully multi user
  • Comprehensive online help
  • Comprehensive security (including Active Directory support)
  • Multilingual
  • Device Management
  • Complaint Management
  • Customer Management
  • Supplier Management
  • Returns Management
  • Incoming Goods
  • Outgoing Goods
  • GDP/GMP Training Module

Key Obligations Of Economic Operators

Obligation
Importer
Distributor
EudaMed Connect
Functionality
Check device is CE marked and EU declaration of conformity
Correct conformity assessment procedure has been performed
Labelling and accompanying Information for use (IFU)
Manufacturer has assigned UDI
Importer has included name and contact details
Transport and storage requirements fulfilled
Keep a register of complaints
Forward complaints to manufacturer / authorised representative / importer
Full traceability of devices received from Supplier and supplied to Customer by Batch/Lot
Expiry date check for inbound and outbound devices
Robust system for supplier approval
Robust system for medical device approval
Swift recall functionality
Register of returned medical devices and approval back into stock

Useful Terminology

  • EUIVDD - (EU) In Vitro Diagnostic Directive 98/79/EC
  • EUIVDR - (EU) In Vitro Diagnostics Regulation 2017/746
  • EUMDD - (EU) Medical Devices Directive 93/42/EEC
  • EUMDR - (EU) Medical Devices Regulation 2017/745
  • IVDD - In Vitro Diagnostic Directive 98/79/EC
  • IVDR - In Vitro Diagnostics Regulation 2017/746
  • MDD - Medical Devices Directive 93/42/EEC
  • MDR - Medical Devices Regulation 2017/745
  • MedTech - Medical Technology
  • MedDevice - Medical Device
  • UDI - Unique Device Identifier

Got A Question ?

  • If you have any further questions or queries in relation to EudaMed Connect or the Medical Devices Regulation in general, then please contact our Customer Helpline number above, or email us at support@quickpharmsolutions.com.

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