EU Medical Device Classes Guide – Class I, IIa, IIb, and III

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EU Medical Device Classes Guide - I, IIa, IIb, and IIIThe Medical Devices Regulation sets requirements according to device class. More specifically, medical devices are defined as class I, IIa, IIb, or III. In turn, this determines certain requirements, and which conformity assessment procedure the manufacturer must follow.

In this guide, we present the different classes for medical devices, explain how medical devices must be classified, delve into the classification rules, and explore the implications of each classification.

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Medical Devices Regulation: An Essential Guide

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Medical Devices Regulation: An Essential Guide
The Medical Devices Regulation (MDR) regulates medical devices and their accessories manufactured or imported for the European Union market.

This guide provides examples of products covered by the Medical Devices Regulation, explains which medical devices require a notified body, and elaborates on various requirements for such products including documentation, labelling, and testing.
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Products covered by the Medical Devices Regulation: An Overview

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Products covered by the Medical Devices Regulation: An Overview

The Medical Devices Regulation covers both products that have a medical purpose, and products without an intended medical purpose – for example coloured non-corrective contact lenses. Additionally, medical devices are divided into different classes, according the risk level. Hence, the requirements vary depending on the class of the device.

It is therefore important to understand if your product is covered by the Medical Devices Regulation and, if so, under which class it belongs.

In this guide, we list examples of products covered by regulation, ordering them by type (e.g. invasive devices), and class (e.g. Class I).

Product List Creation Methodology

1. The product examples listed in this guide are taken from section “4.2 General explanation of rules/practical issues/examples” of the “Guidance on classification of medical devices” that is available on this Guidance page.

a. The product categories listed in this guide (e.g. Non-invasive devices) are taken from the headlines and sub-headlines available in section 4.2.

b. The product examples (e.g. wheelchair) are taken from the tables available in section 4.2.

c. We have sorted the products by class of medical devices (I, IIa, IIb, III), according to the information that is provided in the tables available in section 4.2.

2. The last section of this guide (Groups of products without an intended medical purpose) is an exception.

In this case, we have taken the product examples (e.g. Short-term use coloured non-corrective contact lenses) from section “4 Classification” of the “Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies” that is available on the Guidance page linked above.In

this case, the products are sorted by class, according to the information available in section 4 of the document.

3. Note that the list below is not exhaustive and only provides examples. You can consult the guidance documents for more information.
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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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Medical Devices EU Authorised Representative & UK Responsible Person Guide

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Medical devices

Request a free EU Authorised Representative Quotation Here

Medical Devices are one of, if not the most, complicated, and tightly regulated products to place on the market within the European Union and the United Kingdom. This is not helped by the change from the Medical Device Directive to the new Medical Device Regulations which come into force in May 2021. This has been further complicated by Brexit as different regulations apply in different areas.

The first step is to identify if the product is actually a Medical Device and then which of the Regulation actually applies. Keep reading, and learn what you must know in this article written by International Associates Limited in the UK. Continue reading Medical Devices EU Authorised Representative & UK Responsible Person Guide

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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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

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