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Medical Devices and  EUDAMED 

MedTech Compliance Solutions

Get experienced help to manage and validate EUDAMED UDI data

Bringing a Medical Device to The European Union

To comply with EU Regulations, there are a number of complex regulatory-related tasks that will need attention. The Actor Module, UDI/Device Registration Module and Certificate/NB Module have been open for voluntary industry activity for some time in preparation for the anticipated launch of the EUDAMED database. With the latest amendment approved for mandated use as early as Q4 2025/Q1 2026, starting a regulatory strategy early in the process will help your team keep momentum for EU requirements. 

How can Reed Tech help your team create a strategy for regulatory compliance in Europe and other regions? 

  • UDI Channel Launch: detailed UDI attribute gap analysis, review of new channel business rules, dedicated support during systems integration, technical questions and regulatory compliance guidance.
  • Data Analytics Reports: transform your data into actionable insights with tailored dashboards and analytics reports.
  • Software Customization: custom feature development for SingleSource™ for Medical Devices 
  • Data Integration: UDI API integration for secure and scalable deployment within your IT  infrastructure or cloud environment
  • Data Collection / Migration: Help to collect, cleanse transform and migrate your data to meet the unique needs of each health authority

What is EUDAMED?

EUDAMED (European Database on Medical Devices) is the web-based portal implemented by the European Commission to serve as a centralized database for economic operators (medical device manufacturers worldwide, designated representatives and system/procedure pack providers) for the registration and required EU regulatory information submission. The existing three directives for the European Union–Medical Devices (MDD), Active Implantable (AIMDD) and In Vitro Diagnostics (IVDD)–have been replaced by two regulations: the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostics Regulation (IVDR) 2017/746. Unique Device Identification (UDI) database requirements are being implemented by a number of global health regulators to improve the safety of patients and facilitate product modernization.

RTLS-EUDAMED TIMELINE UPDATED May 1 2024

We invite you to tell us a little about your med device regulatory advisory needs. Let's connect for a consultation!

The Subject-Matter experts at Reed Tech Can Help:

  • Plan for Unique Device Identification (UDI) regulatory requirements for active health authorities including US FDA, EU EUDAMED, China NMPA, South Korea IMDIS, AusUDID and others
  • Leverage requirements expertise from UDI experts in US FDA and other health authorities around the globe
  • Centralize product data in a single data hub for all the Health Authorities in your product markets 
  • Integrate in-country users (subsidiary or affiliate, agent or distributor)
  • Gain auditing and versioning peace of mind for maintaining UDI data
  • Share product data internally or externally with downstream customers

Contact Reed Tech for solutions and services for medical device UDI requirements for EUDAMED and other global health authorities.

“Reed Tech has good knowledge about the UDI demands for different markets around the world.”

– Regulatory Compliance Manager, Dentsply Sirona

 

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