Europe-CE Marking MDR / IVDR

EUDAMED Registration Services

The European Database on Medical Devices (EUDAMED) is an essential platform established under the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). It serves to enhance transparency, improve market surveillance, and facilitate regulatory compliance for medical device (MD) and in vitro diagnostic (IVD) manufacturers operating in the European Union (EU).

At Alpine Quality Consultants, we assist manufacturers, importers, and other economic operators in navigating the EUDAMED registration process, ensuring full compliance with EU regulatory requirements.

What is EUDAMED?

EUDAMED is a centralized European database designed to improve coordination and information exchange between EU Competent Authorities, Notified Bodies, and Economic Operators. It consists of six interconnected modules:

Our BIS Registration Consultancy Services

Actor Registration (Mandatory)

All manufacturers, authorized representatives, and importers must be registered in EUDAMED.

UDI/Device Registration

Unique Device Identification (UDI) and product details must be uploaded.

Notified Bodies & Certificates

Records of CE certificates issued by Notified Bodies.

Clinical Investigations & Performance Studies

Documentation of clinical and performance evaluations.

Market Surveillance & Vigilance

Reporting of serious incidents and corrective actions.

Post-market Surveillance & Trend Reporting

Compliance monitoring and reporting.

Our EUDAMED Registration Services

Actor Registration Support – We guide manufacturers, EU Authorised Representatives (E.A.R), and importers through the actor registration process, ensuring compliance with SRN (Single Registration Number) requirements.

UDI/Device Registration Assistance

  • We help register your medical devices and IVDs, ensuring accurate submission of Unique Device Identification (UDI) information.

Regulatory Document Preparation

  • Our team ensures your documentation aligns with EUDAMED requirements, minimizing the risk of delays or rejections.

Data Submission & Compliance Checks

  • We review and validate your data to ensure full compliance before submission.

Ongoing Regulatory Support

  • Keeping you updated on EUDAMED implementation phases and helping you stay compliant with evolving requirements.

Ensure Seamless EUDAMED Compliance with EUmAccess GmbH

Avoid registration delays and regulatory risks. Let EUmAccess GmbH handle your EUDAMED registration while you focus on bringing safe and effective medical devices to the European market.

Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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