CE Marking: Medical Devices Perry Johnson Registrars, Inc. (PJR) and SZUTEST have joined together to provide CE marking for a wide range of products. One such class of products that SZUTEST is authorized to approve CE Marking for are Medical Devices (93/42/EEC). This CE Marking will allow a company to distribute its products considered medical devices within the European Union, and objectively verify that the product is safe to use. Is my product considered a Medical Device? The European Commission defines a medical device to be any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used by human being for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological immunological or metabolic means, but which may be assisted in its function by such means.

This definition applies to a wide range of products including anesthetic and respiratory equipment, electro-medical apparatus for dentistry and stomatology, non-active implantable medical devices, disposable syringes and needles, and others.

Within medical devices, there are four main classifications (Is, Im, IIa, IIb, and III). Higher risk products get higher classifications and require a greater level of assessment. All the classes require the assistance of a third party Notified Body, like SZUTEST.

What will it take for my Medical Device to get the CE mark?

The product certification process depends on the type of classification your product receives. A company with a class I device must start by establishing a Declaration of Conformity. If the product is sterile or has a measuring device, then the verification of a Notified Body like SZUTEST is required. If not, there is no need for verification. With a class II medical device, there are two options for obtaining a CE mark. The first and most common method involves creating a system with full Quality Assurance. Class III medical devices also have two options for CE certification, the most common method being creating a system with full Quality Assurance, and then having the product's design process examined.

The CE certification process may sound daunting, but PJR and SZUTEST can greatly simplify this process. Please contact PJR at (contact information) for more information about getting the CE mark on your medical device.

Application – Medical Devices

Flyer – Medical Devices