The Medical Device Directives by the European Commission (EC) is directly responsible for the regulations for a medical device in European Union (EU). As per the Medical Device Directives, a CE Marking is needed to put medical devices up for sale on the European market. For entrepreneurs, manufacturers, and pharmaceutical companies, they first must determine the EU classification of their medical device to figure out what requirements to work on to obtain a CE marking.
Definition of Terms
Let’s first go through the definitions that will be necessary for understanding the medical device regulations.
This term refers to an element, tool, application, implant, or software released to be used as a standalone item or together with other devices. A medical device is used for the following:
Diagnostics, monitoring, prediction, prevention, and treatment of diseases;
Support for people with disabilities; and
Examination, modification, or replacement of anatomy, physiology, and physiological processes in the body or any elements that directly or indirectly affect metabolism.
A medical accessory refers to one of the elements that could affect a medical device. It will not be used for any activity listed above but allows a device to work and supports it within its intended use. It is regulated in a separate chapter of the existing medical device regulation.
Determining Medical Device Classification
A medical device can be non-invasive, invasive, or active. Let’s take a closer look at these three broad categories below:
This category refers to any device which does not penetrate the body through an orifice or the surface of the body. These devices fall under Class I of the medical device classification in the EU, which we will delve deeper into in the next section. Certain rules and exceptions apply that could make these non-invasive devices Class II or higher.
The exact opposite of the above-mentioned category, this refers to any device, which penetrates inside the body either through an orifice or the surface. Like with non-invasive devices, there are certain rules which apply to this category. We will get to these rules as we outline the European device classification system in the succeeding sections.
Active devices are those whose operation depends on a source of energy. Their operation is not generated by the body for that purpose or by gravity.
There are certain rules which apply to each of these broad categories. They are outlined in Annex VIII of the new medical device regulation in the EU. This system is similar to the medical device classification in the USA.
Determining the classification of such devices is fairly straightforward. The European Union follows a similar device classification system in the US.
Classifying Medical Devices According to Relevant EU Regulations
Below is a breakdown of the categories for classifying a wide range of medical technologies:
Class I Devices
From walking aids and bandages to compression hosiery, these are non-invasive, everyday devices or equipment. These devices are generally low risk and require only for the manufacturer to complete a technical file to get the CE mark.
Class Is Devices
These are also non-invasive devices. This classification extends to include sterile devices such as examination gloves, stethoscopes, colostomy bags, and oxygen masks. To get a CE mark for these sterile devices, a technical file plus an additional application to a European Notified Body for certification of manufacturing sterile devices are required.
Class Im Devices
This sub-group includes low-risk measuring devices, such as droppers, non-invasive blood pressure measuring devices, and thermometers. Among the requirements for obtaining a CE mark include a technical file and an application to a European Notified Body for manufacturing in accordance with metrology regulations.
Class IIa Devices
Low to medium risk devices, particularly the ones installed within the body in the short term (between 60 minutes and 30 days), fall under this category. Class IIa devices also include hearing-aids, catheters, and blood transfusion tubes. Technical files must be accomplished, and a conformity test must be carried out by a European Notified Body for manufacturers and companies to get a certificate for this medical device classification.
Class IIb Devices
Medium to high-risk devices fall under this sub-group. They are those that will often be installed within the body for periods of 30 days or longer, such as ventilators and intensive care monitoring equipment. Technical forms for compliance route to Class IIb devices and a device type examination by a Notified Body are among the requirements to get a CE mark for these devices.
For medical devices and technologies to be sold in the European market, a CE marking must be obtained. Technical documentation is the first requirement to obtaining CE marking. Companies and manufacturers will need to work with a Notified Body and an authorised representative to take care of product registration.
For more information on classifying medical devices and technologies in the EU, get in touch with a medical device classification consultant like Vicki Partridge. Consultants have extensive knowledge of the systems of device classification around the world, including medical device classification in Asia, Europe, and the USA. Vicki Partridge has been in the industry for more than 30 years, assisting companies when it comes to medical device classification in AU and other markets.