Tag: compliance eu

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.
Continue reading Medical Devices Regulation: An Essential Guide

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.
Continue reading Products covered by the Medical Devices Regulation: An Overview

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.
Continue reading Medical Devices Labelling Requirements in the European Union

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.

Continue reading EU Notified Bodies for Medical Devices: An Overview