Medical Devices
(MD)

What Are Medical Devices?

The term “medical devices” includes many diverse products. These range from consumable items (syringes, catheters, guidewires, needles) to heavy equipment like CT scanners and MRI machines. Medical devices also include wound dressings, implantable devices (cardiac pacemakers, defibrillators, orthopedic prosthetics), and all software for medical purposes.

Defining Medical Device Status

Applicable regulations determine a product’s medical device status. This depends on the market where the manufacturer plans to sell the product.

European Medical Device Definition

In Europe, Regulation (EU) 2017/745 defines what qualifies as a medical device. A medical device is any instrument, apparatus, appliance, software, implant, reagent, material, or other article. The manufacturer must intend it for use in human beings, alone or in combination, for one or more 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 anatomy or of a physiological or pathological process
• Providing information through in vitro examination of specimens from the human body (including organ, blood, and tissue donations)
• The device must not achieve its principal action through pharmacological, immunological, or metabolic means. However, such means may assist its function.

Additional Products Classified as Medical Devices

The following products also qualify as medical devices:

• Devices for the control or support of conception
• Products for cleaning, disinfection, or sterilization of medical devices, their accessories, and products listed in Annex XVI of the Regulation

Medical Device Regulation in Europe

Europe has regulated medical device access since 1990 for active implantable devices (Directive 90/385/EEC) and since 1993 for all other devices (Directive 93/42/EEC). Subsequently, in 2017, the European Union introduced Regulation (EU) 2017/745 to revise these rules. Notably, this new Regulation replaces the Directives and becomes mandatory on May 26, 2021.

Medical Device Risk Classes

To ensure safety, the system divides Medical Devices into 4 risk classes: I, IIa, IIb and III. Accordingly, authorities base these classifications on the device’s intended purpose and potential risks.

Market Access Procedures

Market access procedures vary by device class. Specifically, higher-risk classes require greater involvement from notified bodies.

For instance, Class I devices do not require notified body involvement (except for sterile devices, measuring devices and, under Regulation (EU) 2017/745, reusable devices).

Class IIa and IIb devices need notified bodies for design verification and manufacturing supervision.

Meanwhile, Class III devices require the most comprehensive oversight. In these cases, notified bodies verify the design and supervise both design and manufacturing processes.

Manufacturer Responsibilities

Manufacturers hold legal responsibility for market compliance. Therefore, they must compile evidence documenting conformity and take necessary steps. This includes working with a notified body like GMED when required.

Additionally, when a manufacturer operates outside the European Union, they must appoint an Authorized Representative. This representative then completes tasks related to regulatory obligations.

As a recognized and experienced notified body, GMED offers manufacturers expertise in conducting assessments and applying current regulations.

Regulatory Changes Under EU 2017/745

The European Council adopted Regulation (EU) 2017/745 on April 5, 2017, which becomes mandatory on May 26, 2021. Importantly, this regulation adapts to new technological challenges while ensuring high safety and performance standards. Furthermore, it supports innovation in this dynamic industry.

While maintaining the same conformity principles as the Directives, the new regulation defines the notified body’s scope more clearly. Consequently, this approach aims to harmonize practices and enhance security for patients and device users.

Under these changes, manufacturer requirements become more stringent. As a result, companies must provide more robust evidence of device conformity, especially regarding clinical safety and performance.

GMED’s Expertise

Operating as a notified body under Regulation (EU) 2017/745, GMED provides conformity assessment services for a wide range of devices. You can find GMED’s notification scope on the European Commission website (NANDO – New Approach Notified and Designated Organisations). Moreover, we offer cutting-edge expertise in assessing various medical device technologies.