CE Marking: Medical Devices Perry Johnson Registrars, Inc. (PJR) and SZUTEST have joined together to provide CE marking for a wide range of products, including the products that fall under the Medical Devices Directive (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 beings 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.”

(European Commission, ec.europa.eu)

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 these medical devices, there are four main classifications (Is, Im, IIa, IIb, and III). Higher risk products are assigned higher classifications and require a greater level of assessment.

The subsequent CE marking process depends on the type of classification your product receives.

The CE certification process may sound daunting – PJR and SZUTEST can greatly simplify this process. Please contact PJR for more information about CE marking for your medical device.

Application – Medical Devices

Flyer – Medical Devices