Category: Medical Devices

The 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.

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

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

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

Continue reading Face Mask Regulations and Standards in the EU: An Overview

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