EUDAMED & Medical Device Regulation (MDR) – Compliance Globally
EUDAMED Registration & EU MDR Medical Device Compliance
Full compliance with Regulation (EU) 2017/745 (MDR) and IVDR 2017/746. We secure your Single Registration Number (SRN), register foreign manufacturers in the EUDAMED database, assign Basic UDI-DIs, and review clinical evaluation files.
Single Registration Number (SRN)
EUDAMED Actor Registration
Basic UDI-DI Assignment
PRRC Regulatory Support
EU Regulatory Desk Active
EUDAMED Medical Regulatory Desk
Direct liaison with European Competent Authorities for medical device and IVD market access.
Transparent European Market Packages
Full conformity with EU Regulations, direct representation, and guaranteed regulatory acceptance across all 27 Member States.
/ package
Procurement of Single Registration Number (SRN) for non-EU manufacturers.
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Competent Authority Actor Filing -
Single Registration Number (SRN) Issuance -
EUDAMED User & Administrator Setup -
Verification with Authorized Representative
/ package
Basic UDI-DI allocation and device registration in EUDAMED.
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SRN Registration Included -
Basic UDI-DI Structure Creation -
Device Attributes Registration in EUDAMED -
Summary of Safety and Clinical Performance (SSCP) Check
/ package
End-to-end regulatory support for Class I, IIa, and IVD products.
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Full EUDAMED Registration -
Technical Documentation Audit under Annex II/III -
Post-Market Surveillance (PMS) Protocol -
PRRC Compliance Alignment
Mandatory European Documentation & Dossiers
Ensure smooth market entry and customs clearance across the EU Single Market.
Quality Management Certificate
ISO 13485:2016 certificate covering manufacturing and design scope.
Device Classification File
MDR Rule justification file confirming Class I, Class IIa/b, or Class III status.
Basic UDI-DI Code
Unique identifier issued by authorized agency (GS1, HIBCC, ICCBBA).
EC-REP Mandate Agreement
Official signed European Authorised Representative contract.
Conformity & Market Access Roadmap
Structured European compliance verification from technical file review to official market release.
Actor Submission
Submit economic operator registration request to the national Competent Authority through EUDAMED.
SRN Issuance
Receive the official Single Registration Number (SRN) recognized across the entire European Union.
UDI & Device Registration
Upload device identifier attributes, nomenclature codes (EMDN), and risk classifications.
Market Activation
Enable legal commercial distribution and public traceability on the European market.
Frequently Asked Questions
Key regulatory guidance covering EU-REP mandates, CE marking directives, and EUDAMED requirements.
What is a Single Registration Number (SRN)?
An SRN uniquely identifies every economic operator (manufacturer, authorised representative, importer) in EUDAMED and on official certificates under the MDR.
When is EUDAMED mandatory?
Actor registration and device modules are actively required by European Competent Authorities and notified bodies for all legal market entries.