Category: European Union

Face Mask Regulations and Standards in the EU: An Overview

Posted on by Vincent Cheng — 15 Comments

Face Mask Regulations in the EU
Planning to import medical or protective face masks to the European Union? In this guide, we cover product regulations, EN standards, labeling, certification, and lab testing requirements when importing or manufacturing various types of face masks for the EU.

Mentioned Products

  • 3-ply surgical face masks
  • 4-ply- surgical face masks
  • 5-ply surgical face masks
  • FFP1 mask or respirators
  • FFP2 masks or respirators
  • N95 masks or respirators
  • FFP3 masks or respirators
  • N99 masks or respirators

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EU Medical Devices Directive Guide: By Anssi Ilmari Tynjälä

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Medical Devices Directive

Face masks, medical gloves, and other medical devices are regulated by the Medical Devices Directive in the European Union. The scope of the Medical Devices Directive covers safety standards, labeling, quality management systems, product registration, and documentation. Further, some medical devices are more strictly regulated than others.

In this guide, written by Anssi Ilmari Tynjälä from Innovapro, you will learn what it takes for importers and manufacturers to ensure compliance with the Medical Devices Directive. Continue reading EU Medical Devices Directive Guide: By Anssi Ilmari Tynjälä

Earphones Safety Standards in the European Union: An Overview

Posted on by Chuiyan Mo — 1 Comment

Earphones Safety Standards European Union
Earphones imported or manufactured in the EU must comply with regulations, such as RoHS, REACH and the Radio Equipment Directive. In this guide, we list relevant EU standards, regulations, certification and labeling requirements for both wired and wireless earphones.

Mentioned products

  • Earbuds
  • Headsets
  • Noise-canceling earphones
  • Bluetooth earphones
  • Wireless earphones
  • Wired earphones

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Helmet Safety Standards in the European Union: An Overview

Posted on by Vincent Cheng — 5 Comments

Helmets Safety Standards European Union
Helmets of various kinds are normally classified as Personal Protective Equipment in the European Union. In this guide, we cover the PPE Directive, EN standards, REACH, certification, labeling and other requirements when importing or exporting helmets to the EU.

Mentioned Products

  • Bicycle helmets
  • Children’s helmets
  • Motorcycle helmets
  • Construction helmets
  • Military helmets
  • Ski helmets

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List of Products Covered by the Radio Equipment Directive (RED)

Posted on by Vincent Cheng — 1 Comment

The Radio Equipment Directive (RED) applies to all Wi-Fi, Bluetooth, LTE, 5G, GPS and other radio-electric enabled devices sold in the European Union. In this guide, we cover the basics of RED requirements for smartphones, smartwatches, computers and other electronic products. Continue reading List of Products Covered by the Radio Equipment Directive (RED)

List of Products Covered by the EU Battery Directive

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Battery Directive Product List

In this article, we list different types of batteries covered by the EU Battery Directive 2006/66/EC, including lithium batteries, nickel-cadmium batteries, button cell batteries, and other types of batteries. In addition, we also list relevant EN standards. Continue reading List of Products Covered by the EU Battery Directive

List of Products Covered by the EU Medical Devices Directive

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Medical Devices Directive Product List

Planning to import and sell prescription glasses, medical gloves, thermometres or other related medical products in the European Union? If so, chances are that you must ensure compliance with the Medical Devices Directive. In this guide, we list both exemptions and products covered by the scope of the Medical Devices Directive. Continue reading List of Products Covered by the EU Medical Devices Directive

List of Products Covered by the EU FCM Framework Regulation (No 1935/2004)

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FCM Framework Regulation Product List

The EU Food Contact Materials Framework Regulation 1935/2004 covers plastic, ceramic, metal and other food contact materials. In this guide, list kitchen appliances, food packaging, wooden composites and other products covered by the scope of the regulation. Continue reading List of Products Covered by the EU FCM Framework Regulation (No 1935/2004)

List of Products Covered by the Toy Safety Directive and EN 71

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Toy Safety Directive EN 71 Product List
Planning to sell toys, children’s furniture or other children’s products in the European Union? If so, then compliance with the Toy Safety Directive is required. In this guide, we list products covered by the Toy Safety Directive, and some exemptions.

Continue reading List of Products Covered by the Toy Safety Directive and EN 71