MDR: The EU Medical Device Regulation

Simply put, the EU MDR is a regulation created to protect patients and ensure the safe and effective use of medical devices with a focus on quality management systems implementation.

The European Union (EU) created this new regulatory framework for the clinical investigation and sale of medical devices for human use.

The MDR (Medical Device Regulation) ensures that patients are not exposed to unsafe products while allowing manufacturers to innovate and improve their products.

While the MDR has been in effect for quite some time, the regulation is complicated enough that it is easy to lose track of a few terms. In this glossary article, we have combined some of the most common terms and info you need to know about MDR.

What is the MDR?

Strictly speaking, MDR is the regulation titled “REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017”.

It was published on 5 April 2017. But it came into effect on the 25th of that month. The MDR set a new standard for medical devices to be marketed in EU countries.

This regulation aims to harmonize regulations and standards for medical devices throughout Europe. This includes everything from how the device should be labeled to what requirements must be met for a device to be approved for sale in any country within the EU.

The MDR Also reinforces supervision of notified bodies, thorough clinical investigation process, conformity with risk assessment procedures and clinical evaluation, vigilance, and market surveillance.

These were previously included in MDD in some form. However, the processes were given the highest emphasis in MDR.

It also emphasizes keeping with international standards. According to the MDR document, the standards should consider the Global Harmonization Task Force (GHTF) along with the International Medical Devices Regulators Forum (IMDRF) while being enforced.

This reinforces the emphasis on international standards and having state-of-the-art solutions for medical devices.

Scope of MDR

The scopes of MDR can be summarised as follows:

The MDR rules apply to medical devices and accessories placed on the market for human use, making them available in the market. It also applies to all the clinical investigations regarding these.
MDR regulation also applies to the group of products which do not have an intended medical purpose, according to the Annex XVI of the MDR document.For these devices, the state-of-the-art and previously existing standards used for similar devices used for medical purposes and based on similar technology will be used.
Devices with medical and non-medical purposes will be held to the standards of the devices with an intended medical purpose and those without an intended medical purpose.
The MDR considers medical devices, accessories, and products listed in Annex XVI of MDR as “medical device.” However, Annex XVI is amendable, so any device can be added if necessary.
MDR does not apply to In Vitro Medical devices, cosmetic products, or food, among other things.
However, devices that also acts as part of IVDR will fall under the MDR rules, depending on whether it works as a medical device.
Devices “intended to administer a medicinal product” will be held to MDR standards.
Any and all devices that incorporate non-viable human tissues or cells as an integral part that have an ancillary action should also be held standard to the MDR regulations.
Other than a few additional legal clarifications, these are the gist of the MDR scope.

Although the MDR is an effective regulation, with several guidance documents and additional corrections, the basic definitions stay the same.

Here are some of the essential terms and concepts.

Medical Device

It is defined as

“any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state,

providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations.”

Apart from these, the products that control or work to support conception and the devices intended for cleaning, disinfecting, or sterilizing of devices mentioned above are also considered medical devices.

An accessory of a medical device is defined as an “article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical devices.”

An implantable device is defined as

“any device, including those that are partially or wholly absorbed, which is intended:

to be totally introduced into the human body, or

to replace an epithelial surface or the surface of the eye,

by clinical intervention.”

Implantable devices are usually left within the body after the procedure.

Unique Device Identifier

MDR introduced the UDI to ensure all devices can be tracked and any adverse event reports submitted are more specific.

‘UDI’ is defined as a

“series of numeric or alphanumeric characters that are created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market.”

Safety and Performance Specifications

Performance is defined as

“performance means the ability of a device to achieve its intended purpose as stated by the manufacturer.”

The intended purpose is defined as

“use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation.”

To ensure the device’s performance is up to the requirements, manufacturers are required to conduct clinical investigations, which are

“any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.”

Clinical data is usually obtained through professionals and research organizations using the devices and from tests run by the manufacturers to ensure effectiveness.

As the manufacturer is responsible for ensuring regulatory compliance and implementing new regulations based on device types, manufacturing companies emphasize following the regulatory requirements and proper pre and post-market surveillance.

CE Marking

After the device has been approved by the notified body and associated regulatory authority, the device is found conforming to MDR and given a CE marking.

It is defined as

“a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing.”