Medical Devices
(MD)

The term “medical devices” includes a multitude of very diverse products ranging from consumable products (syringes, catheters, guidewires, needles, etc.) to heavy equipment like CT scanners, Magnetic Resonance Imaging machines (MRI’s), from wound dressings to active or non-active implantable devices (cardiac pacemakers/defibrillators, orthopedic prosthetics, etc.) and all software used for medical purposes.
A product’s medical device status is determined relative to the definition set by applicable regulations in the market where the manufacturer plans to sell its product.
In Europe, Regulation (EU) 2017/745 defines a medical device 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;

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:

• devices for the control or support of conception;
• products specifically intended for the cleaning, disinfection or sterilization of medical devices, of accessories for medical devices, and of products listed in Annex XVI of the aforementioned Regulation.

The European market has regulated medical device access since 1990 for active implantable medical devices (Directive 90/385/EEC) and since 1993 for all other devices (Directive 93/42/EEC). In 2017, a revision was introduced to the rules with Regulation (EU) 2017/745. This new Regulation replaces the Directives and becomes mandatory as of May 26, 2021.

Medical Devices are divided into 4 increasing risk classes, I, IIa, IIb and III, based on their intended purpose and the potential risks of their use or design.

Procedures for accessing the European market vary depending on the device class. The higher the class, the greater the involvement of notified bodies. Notified bodies are not involved for class I devices (except for sterile devices, measuring devices and, under the new Regulation (EU) 2017/745, reusable devices). For class IIa and IIb devices, they are involved with a level of control limited to design and manufacturing supervision. For class III devices, the work of notified bodies includes verification of the design as well as design and manufacturing supervision.

Manufacturers are legally responsible for placing devices on the market that conform to applicable requirements in force. They are responsible for putting together evidence to document this conformity and taking the necessary steps, involving a notified body such as GMED when necessary.

When a legal manufacturer is located outside of the European Union, it appoints an Authorized Representative for the purpose of completing the necessary tasks related to its obligations as a manufacturer under regulatory requirements.

GMED, a recognized and experienced notified body, offers manufacturers its skills in conducting the appropriate assessments and applying the regulations in force.

Regulatory changes

Regulation (EU) 2017/745, adopted by the European Council on April 5, 2017, will be mandatory as of May 26, 2021. The purpose of this new regulation, which is necessary to adapt to new technological challenges, is to ensure a high level of safety and performance of medical devices while allowing for innovation that is very prominent in this industry.

Although the principles in terms of demonstrating medical device conformity are identical to the Directives, the scope of the notified body’s work is defined and aims to harmonize practices and provide a high level of security for patients and medical device users.
Requirements for manufacturers in terms of demonstrating conformity of their medical devices with safety and performance requirements, especially clinical ones, are also enhanced.

GMED, a notified body under Regulation (EU) 2017/745, provides conformity assessment services for a wide range of devices (The scope of GMED’s notification is available on the European Commission website : New Approach Notified and Designated Organisations NANDO) and offers cutting-edge skills in assessing the various technologies used.