In order for certain types of products to enter the European market, they must bear the CE Mark. The CE Mark is a self-certification that is required for 20+ product categories, including medical devices.
If the product is in one of the categories that requires CE marking, it must have the CE designation before it can be sold in any EU member country, or in any of the countries that have adopted some EU standards. The EU Single Market includes 500 million consumers and 21 million small- to medium-sized businesses—a huge opportunity for medical device manufacturers who self-certify according to CE requirements.
It’s important for medical devices to have the
CE Mark for several reasons:
●
Demonstrates compliance with EU standards - The
CE Mark shows European regulatory and compliance authorities that the product
complies with all relevant standards. Without this demonstration of conformity,
a product could be removed from the market or prevented from entering the
market in the first place. In addition, the manufacturer of the product could
be penalized for marketing or distributing a non-compliant product.
●
Ensures predictable device operation - Patients
and medical providers rely on medical devices every day for the diagnosis,
treatment, and prevention of medical issues. If a device does not operate as
expected, it could exacerbate an ongoing problem or create a new one. By
testing the product thoroughly and ensuring it meets key performance standards,
companies can ensure their devices are reliable and build trust among
consumers.
●
Enter the entire European Single Market with one Mark - The consolidation of standards in Europe means that one mark—the CE
Mark—can unlock an incredibly large market. From a business standpoint,
following the steps to obtain the CE Mark creates a significant opportunity for
a product’s growth.
What Medical Devices Need the CE Mark?
The term “medical devices” covers a wide range of products—everything from splints and cloth bandages to blood pressure readers and advanced diagnostic equipment.
Regulation (EU) 2017/745 defines “medical devices” 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; or providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.”
According to EU Regulation 2017/745, devices for the control or support of conception, and products designed to clean, disinfect, or sterilize medical devices also need the CE Mark to be sold to the European market.
Despite these definitions, there is no
comprehensive list of products that must bear the CE Mark. Instead, the
European Commission requires manufacturers, distributors, and compliance
professionals to review the directives and determine if the product in question
falls within the scope of those directives.
Contact G&M Compliance for
More Information
The compliance professionals at G&M
Compliance can help you determine if your product needs the CE Mark, and if so,
the best way to demonstrate compliance with applicable standards. world today. Contact
G&M Compliance today to learn more about the CE Mark and how it
applies to your product.