Disposable Syringe Manufacturing

Disposable Syringe Manufacturing Process and Regulatory Compliances in the Netherlands

/ Medical Devices Manufacturing / By

Introduction

With increasing demand for safe, single-use medical products, disposable syringes have become a vital component in modern healthcare. The Netherlands, known for its advanced healthcare infrastructure and stringent regulatory standards, offers a promising market for manufacturers. However, to establish a disposable syringe manufacturing facility in the Netherlands, companies must adhere to precise manufacturing protocols and regulatory compliances. 

This blog provides an in-depth look into the manufacturing process, regulatory landscape, and how Operon Strategist supports manufacturers in setting up compliant and efficient syringe production plants in the Netherlands. 

What Is a Disposable Syringe?

A disposable syringe is a single-use device used to inject or withdraw fluids from the body. It is typically made of polypropylene and comprises a barrel, plunger, and needle. The primary advantage is eliminating cross-contamination, making them essential for hospitals, clinics, and diagnostic centers.

Step-by-Step Disposable Syringe Manufacturing Process

  1. Raw Material Selection
  • Use of medical-grade polypropylene (PP) and stainless steel 
  • Compliance with ISO 10993 for biocompatibility 
  1. Injection Molding
  • Syringe barrels and plungers are formed using high-precision molds 
  • Controlled environments to avoid contamination 
  1. Needle Assembly
  • Stainless steel needles are cut, ground, and attached using automated equipment 
  • Needle bonding with adhesive or mechanical locking 
  1. Lubrication
  • Internal barrel walls are lubricated using silicone oil to ensure smooth plunger movement 
  1. Printing & Marking
  • Graduated markings are printed using non-toxic ink (ISO 15223-1 compliance) 
  1. Sterilization
  • Ethylene Oxide (EtO) or Gamma Radiation 
  • Must follow ISO 11135 or ISO 11137 sterilization standards 
  1. Packaging
  • Blister or pouch packing under ISO 11607 guidelines 
  • Packaging validation is critical for shelf-life and sterility assurance 
  1. Quality Control & Batch Release
  • Dimensional inspection, leak tests, needle pull tests 
  • Documentation as per ISO 13485 QMS 

Regulatory Compliances in the Netherlands

To market disposable syringes in the Netherlands, manufacturers must comply with both national and European Union regulations. 

Key Regulations:

1. EU MDR 2017/745 

  • Classification: Class IIa or IIb (depending on design and needle assembly) 
  • Essential requirements: GSPRs, UDI, Clinical Evaluation, Risk Management 
  • Requires CE Marking from a Notified Body 

2. ISO 13485:2016 

  • Implementation of a Quality Management System specific to medical devices 
  • Mandatory for CE certification 

3. Dutch Healthcare Authority (NZa) & IGJ 

  • Oversight of medical device distribution and surveillance 
  • Requires local authorized representative for non-EU manufacturers 

4. UDI & EUDAMED Registration 

  • All syringes must carry a Unique Device Identifier (UDI) 
  • Registration on EUDAMED portal is mandatory for traceability 

5. Labeling & Language Requirements 

  • Instructions for use (IFU) must be available in Dutch 
  • Follow ISO 15223-1 and EU MDR labeling requirements 

Benefits of Setting Up Syringe Manufacturing in the Netherlands

  • Access to EU-wide markets post-CE approval 
  • Strong logistics and R&D infrastructure 
  • Favorable investment climate for MedTech startups 
  • Skilled workforce and government innovation incentives 

Role of Operon Strategist

Operon Strategist is your end-to-end consulting partner for setting up a disposable syringe manufacturing facility in the Netherlands. 

We Help With:

  • Plant layout design in compliance with EU GMP and ISO 14644 (Cleanroom standards) 
  • Machine selection and technical guidance for syringe molding, assembly, and sterilization 
  • ISO 13485 QMS implementation tailored for disposable syringe production 
  • EU MDR documentation & CE marking support 
  • Sterilization validation as per ISO 11135 or 11137 
  • Packaging design aligned with ISO 11607 
  • UDI & EUDAMED registration support 
  • Liaison with Dutch regulatory authorities 

With our global expertise in regulatory compliance, Operon Strategist ensures you stay compliant, competitive, and confident throughout your manufacturing and approval journey. 

Need Help Starting a Syringe Manufacturing Plant in the Netherlands?

Let Operon Strategist streamline your regulatory path, facility design, and CE compliance. 

📩 Contact Us Today for a free consultation!