Who needs the CE Mark and CE certification? A primer for medical device manufacturers

Europe is easier to access than ever before. Still, many North American exporters, especially small and medium sized enterprises, avoid it because the regulatory requirements for entry seem too complicated or expensive. North American manufacturers who have successfully accessed the European market know that taking the time to understand the European system is worth the effort. The European Union has a population of 490 million people, about the same as all of North America.

The European Union now includes 27 countries. Three additional countries (Iceland, Liechtenstein and Norway) are not EU members but are included in the European Economic Area (EEA). Switzerland is not part of the European Union.

For the exporter, Europe's regulatory requirements are easier to meet than even before. Before the creation of the European Union, each country imposed its own regulations. Different standards and regulatory procedures forced exporters to target one or two countries only, or to forego exporting to Europe altogether. The unification of 27 European countries into a European Union, and the resulting unification of laws, standards, and procedures, changed all that.

The CE "certification" of medical devices - entry stamp to the European market

The CE Marking of a product is required by law if the product falls under one of the New Approach Directives, also known as the CE Marking directives. Medical devices are covered by three New Approach Directives, namely: Medical Devices Directive (MDD 93/42/EEC), Active Implantable Medical Devices Directive (AIMDD 90/385/EEC); and In-Vitro Diagnostics Directive (IVDD 98/79/EC). The CE Mark is not a quality mark, nor is it a symbol intended for consumer assurance. The real purpose of the CE Mark is to act as a visible sign to let member State authorities know that your product is in compliance with the applicable directive(s). All manufacturers are required to affix the CE Mark to products that are governed by the Directives noted above.

Parties involved in CE Marking

There are several entities involved in CE Marking. We will discuss each one and their role.

The Manufacturer

The manufacturer is the person responsible for designing and manufacturing a product covered by a New Approach Directive. Regardless of whether a manufacturer outsources design or manufacturing, they are ultimately responsible for the product and compliance with the respective national laws. In accordance with European legislation, a person acting as the manufacturer of the product, even if he or she is not the producer, is considered a manufacturer in the eyes of the law. This also applies to the "private labeler" who does not manufacture the product, but places it on the market under his or her brand name. The "private labeler", therefore, as a "de facto" manufacturer, is ultimately responsible for compliance with all requirements including post-market surveillance.

The Authorized Representative

An Authorized Representative (AR) is an entity appointed by the manufacturer and delegated to act on their behalf to carry out certain tasks required by the medical device Directives. The AR must be established inside the European Union and be available to Member State Authorities. The manufacturer, however, remains ultimately responsible for the actions carried out by the AR.

The Directives require that the AR be listed on the device label or packaging, in the Instructions For Use and on the Declaration of Conformity. In addition, the AR keeps the Technical File available for review by Competent Authorities, and plays an essential role in the post-market surveillance and vigilance system.

The Importer and Distributor

An importer is loosely defined as an entity legally established within the European Union who places a product from a country outside the EEA on the European market. The Distributor can be the importer, but is NOT considered as such if the goods they distribute are procured from within Europe. The role of a distributor who is NOT the importer is not clearly defined in the law with regard to post-market surveillance and vigilance, despite the fact that distributors are an important entity in the distribution chain.

The Competent Authorities

Competent Authorities are usually the national Ministries of Health. They are responsible for monitoring medical products on the market and taking appropriate steps to ensure that dangerous products don't enter (or are removed from) the marketplace. As such, the Competent Authority may require access to the manufacturer's Declaration of Conformity and Technical File/Dossier. The manufacturer, his Authorized Representative or importer, must be able to provide these documents upon request. If the product is found to be non-compliant, corrective action will depend on, and be appropriate to, the level of non-compliance.

It should be noted that the Competent Authority will hold accountable the person (in most cases, the manufacturer) who was responsible for affixing the CE marking to a non-compliant product. Others who are responsible for the non-compliance of the product will be held accountable as well.

Customs Officials

The creation of the European internal market has resulted in the disappearance of borders between European Union Member States, thus making enforcement a lot more effective, and giving an increased role for border Customs agents in market surveillance. Customs officials have focused on getting up to speed with medical device legislation and are becoming more efficient with product inspections. There have been increased communications and requests coming from Custom officials regarding regulatory compliance and non-European manufacturers are more exposed to Customs inspections than their European counterparts.

The Notified Bodies

Notified Bodies are independent testing houses, laboratories, or product certifiers authorized by the EU Member States to perform the Conformity Assessment Tasks specified in Directives, such as quality system audits and device compliance testing. A Notified Body is appointed by a Member State and must have the necessary qualifications to meet the testing and/or certification requirements set forth in a directive. A Notified Body not only needs to be technically competent and capable of carrying out the specified conformity assessment procedures, it must also demonstrate independence, impartiality and integrity.

Devices that qualify for CE self-certification by the manufacturer do not require the intervention of a Notified Body. Medium and higher risk devices, however, do require the intervention of a Notified Body which will be responsible for auditing the Manufacturer's quality system. The Notified Body will also determine whether or not the product conforms to the requirements of the applicable directive. The Notified Body will audit the Manufacturer's quality assurance system or carry out testing and some form of production audit or sample examination.

The End User

End users play an important role in the vigilance chain because they report events and/or findings to Competent Authorities, manufacturers, Authorized Representatives and distributors. Certain European Member states have regulated reporting schemes in which, for example, medical professionals or hospitals are required to report incidents to Competent Authorities.

As more Competent Authorities put increased emphasis on monitoring product performance in the marketplace and making sure that manufacturers are implementing proper surveillance procedures, post-market surveillance will become an important issue for manufacturers, Authorized Representatives, importers, distributors and end users.

January 2005