Medical device manufacturers seeking to export products to European Union (EU) countries must consider whether they need to obtain the CE mark for their products. CE is an acronym for the French phrase, "Conformite Europeenne" and means "European conformity." The CE mark does not signify quality approval, but rather indicates that the product manufacturer has complied with the applicable EU standards ("directives") for consumer safety. A CE mark is generally required on all medical devices in order to gain access to the EU market as well as the general European Economic Area (EEA). Device manufacturers who have gone through the conformity assessment process may affix the CE mark to their product.
Determining the Need for the CE Mark
A comprehensive list of products requiring the CE mark does not exist; therefore, the burden of determining whether the mark is required for a medical device lies with the device manufacturer. The EU has issued specific directives that outline the requirements that need to be met and the procedures that must be followed in order for a medical device to obtain the CE mark. The major directives important to medical device manufacturers are divided into the following three categories:
- Active implantable medical devices,
- Medical devices (non-implantable), and
- In-vitro medical devices. Device manufacturers must look to these directives and make a judgment as to whether the CE mark is required, and if so, the appropriate method by which it must be obtained.
Obtaining the CE Mark
Obtaining the CE mark can be done by selfcertification or by a "Notified Body." The classification of the device determines whether a manufacturer can self-certify or whether they must obtain the services of a Notified Body.
Self-Certification: Self-certification allows a medical device manufacturer to make its own determination that the product meets the requirements to obtain the CE mark. Simple in-vitro diagnostic test kits such as those for diabetes may be allowed self-certification, but more complex test kits such as those for HIV will require certification by a notified body.
Certification by a Notified Body: Medium and high risk devices require the mark to be obtained through a "Notified Body." A notified body is an independent testing house or laboratory authorized by the EU to perform product testing for compliance with directives. It audits the manufacturer's quality system and determines whether or not the product conforms to the requirements of the applicable directive. Products subject to this process may include but are not limited to syringes, bandages, wheelchairs, contact lens solutions, endoscopes, and more complex test kits such as those for HIV.
Although there may be similarities between FDA requirements and EU Directives for a medical device, it does not follow that a product approved by the FDA will meet EU standards. Medical device manufacturers seeking entry for their product to the EU should consult with experts on the EU's certification standards and related CE mark requirements.