Email: cs@nedystec.com
A Professional, Compliant EU Regulatory and Supply Chain Partner
NEDYS is a Netherlands-based regulatory and supply chain partner specializing in medical device EU Authorized Representative (EU REP) services, importer services, Free Sale Certificate (FSC) services, warehouse, logistics, and order fulfillment solutions.
With 10+ years of medical device regulatory expertise, legal EU entity and direct authority access, we deliver full-cycle compliance for fast and reliable European market entry.
An EU Representative is an individual or legal entity established in the European Union that represents non-EU companies processing the personal data of individuals in the EU without a local establishment, acting as the designated contact point for data subjects and supervisory authorities to support GDPR compliance and related communications.
A Certificate of Free Sale (CFS) is a crucial document for manufacturers and authorised representatives exporting medical devices outside the EU. Issued under Article 60 of Regulation (EU) 2017/745 (MDR), it confirms that the device complies with EU regulatory requirements, bears the CE marking, and may be lawfully marketed within the EU.
NEDYS delivers fully customizable, MDR-compliant warehouse solutions with dedicated temperature-controlled zones, modern equipment and GMP/GDP-certified services to ensure safe, efficient and tailored end-to-end logistics support for your medical products.
Temperature controlled placement
Inflammable
Racking placement
Pallet placements
High security
Dynamic picking placement
Outsize
NEDYS is your one-stop solution for EU logistics, compliance, and supply chain excellence. Headquartered in the Netherlands, our strategic hub powers 48-hour pan-European distribution, while our local team delivers efficient, on-time delivery and end-to-end cargo safety. We combine optimized routing, consolidated shipments, and deep EU customs expertise to reduce costs, minimize delays, and ensure full regulatory compliance for your medical device business.
NEYDS provides tailored order fulfillment services for medical and specialized products, covering end-to-end order management, precise pick-and-pack, urgent order handling, structured return logistics and dedicated customer support.Our process ensures full compliance, traceability and reliable delivery to meet the strict requirements of healthcare clients worldwide.
An importer is a natural or legal person in the EU who receives a medical device from outside the EU and sells or supplies it in the EU for the first time. “Placing on the market” means making the device available in the EU.
01
Over 10 years of EU REP experience for your compliant EU market entry.
02
From EU REP to Order Fulfillment. End-to-end logistics and compliance support.
03
MDR-aligned and modern warehousing for safe medical device storage.
04
Experienced multilingual team supporting 30+ clients in regulatory registration.