Medical Devices Labelling Requirements in the European Union

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Medical Devices Labelling Requirements EU
Products covered by the Medical Devices Regulation are required to be accompanied by labelling information, such as CE marking, traceability information, notified body information, and instructions.

This guide serves as an introduction to labelling requirements in the context of the Medical Devices Regulation.
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EU Notified Bodies for Medical Devices: An Overview

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EU Notified Bodies for Medical Devices

Certain products covered by the Medical Devices Regulation (MDR) require the involvement of a notified body before being placed in the EU market. The extent of the involvement of the notified body is determined based on the classification of the medical device.

In this guide, we explain in which case a notified body should be approached. Additionally, we provide a list of various notified bodies in the EU for medical devices and explain how you can search for a notified body in other EU member states.

Methodology

The list of EU-notified bodies that we provide is retrieved from the notified bodies (NANDO) database. Note that we only provide examples of notified bodies for some countries, not a definitive list.

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List of Medical Devices Lab Testing Companies: Our Top 11 Picks

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Medical Devices Testing Lab

Product compliance is essential when importing or manufacturing medical devices, including face masks, medical gloves, and other products. Verifying medical device compliance requires the involvement a of qualified third-party testing company.

In this guide, we’ve listed 11 lab testing companies in the United States, Europe, and Asia, offering a wide range of testing and certification services for medical supplies. Continue reading List of Medical Devices Lab Testing Companies: Our Top 11 Picks

FDA Regulations For Medical Devices: An Overview

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FDA Medical Devices Regulations

Are you planning to import, export, or manufacture medical devices in the United States? In this guide, we introduce you to lab testing requirements, classification, device registration, labeling, GMP and premarket submissions.

Mentioned Products

  • Medical thermometers
  • Medical masks and respirators
  • Medical gloves
  • Medical gowns

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Face Mask Regulations and Standards in the United States: An Overview

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Face Mask Regulations United States

Planning to import N95, N99 or other face masks into the United States? In this guide, we cover the basics of face mask and respirator standards, FDA requirements, labeling requirements, lab testing, and more.

Mentioned Products

  • 3-ply, 4-ply and 5-ply surgical masks
  • N95, N99, N100 masks or respirators
  • FFP1, FFP2, FFP3 masks and respirators
  • KN95 masks or respirators

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Face Mask Regulations and Standards in the EU: An Overview

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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