CE Marking & MDR / IVDR
Technical file gap analysis, clinical documentation, quality alignment and Notified Body support.
- Technical documentation remediation
- CER, PEP and PMS support
- ISO 13485 alignment
Netherlands-based EU regulatory partner
Your route into the European medical device market.
From regulatory strategy and CE marking to Dutch EC REP representation, import and distribution—ANMA Medicals makes European market access clear.
EU MDR & IVDRRegulatory expertise
Dutch EC REPLegal European presence
End-to-endCompliance to distribution
How ANMA Medicals supports your market entry
One partner across your European journey.
A connected set of regulatory and commercial services for non-EU medical device and IVD manufacturers.
EUDAMED & UDI
Actor registration, SRN requests and accurate device data management across the product lifecycle.
- Actor registration and SRN
- Basic UDI-DI data mapping
- Lifecycle database updates
Dutch EC REP
A legally established European representative and direct liaison with competent authorities.
- Article 11 legal mandate
- Qualified PRRC oversight
- Vigilance and incident support
EU Import & Distribution
Compliant importer verification, Dutch customs support and a clear route to European distribution.
- Article 13 verification
- Label and declaration checks
- EU distribution setup
EU readiness assessment
Understand your likely path to market.
Select your current device profile for an initial indication of timing and core requirements.
This is an initial orientation. A detailed regulatory review is required for a definitive roadmap.
Indicative timeframe1–3 months
Notified BodyRequired — Notified Body assessment
EC REP required for non-EU manufacturers
EUDAMED registration required
A structured route forward
Four steps from documentation to distribution.
Technical gap analysis
We review your documentation, clinical evidence, labelling and regulatory readiness.
CE mark & EUDAMED
We close documentation gaps, coordinate filings and prepare accurate registration data.
Dutch EC REP setup
We establish the mandate, European address and ongoing PRRC oversight.
Import & distribution
We complete importer verification and prepare your route to EU healthcare markets.
Your Netherlands partner
Global MedTech innovation, connected to European healthcare.
ANMA Medicals B.V. gives manufacturers outside the EU a clear, accountable regulatory presence in the Netherlands. Our specialists coordinate compliance, authority communication and market access around one practical roadmap.
Central EU gateway
A strategic base for European regulatory and distribution activity.
Authority interface
Direct, accountable communication with competent authorities.
“Our purpose is to remove regulatory friction so valuable medical innovations reach European healthcare systems with confidence.”
Legal mandateEU Authorised Representative
JurisdictionThe Netherlands
Quality focusMDR / IVDR & ISO 13485
Frequently asked questions
European market access, clarified.
Why does a non-EU manufacturer require an EU Authorised Representative?
Under Article 11 of EU MDR, a manufacturer outside the EU must designate a single Authorised Representative established in the European Union before placing a device on the market.
What is the difference between an EC REP and an EU Importer?
The EC REP represents the manufacturer before European authorities and oversees regulatory obligations. The importer verifies compliance before placing a device from a third country on the EU market.
Can ANMA Medicals manage EUDAMED Actor Registration and SRN?
Yes. As your designated Dutch EC REP, ANMA Medicals supports Actor Registration, verifies the application and coordinates the process leading to SRN issuance.
Does ANMA Medicals provide PRRC support?
Yes. ANMA Medicals provides qualified regulatory personnel to support Article 15 obligations, vigilance, authority communication and ongoing compliance.
Start the conversation
Plan your European market entry.
Tell us about your company and device. Our regulatory team will review your needs and respond with the right next step.
ANMA Medicals B.V., The Netherlands
info@anmamedicals.com