The medical device CE mark affixed to a device demonstrates compliance with the applicable European Directives and Regulations and enables the marketing of your product across all EU member states without further control. In spite of similarities with the US FDA, the EU regulations are thought to be less bureaucratic, leading to a shorter time to sell products, lesser costs of obtaining European CE approval, and gaining greater acceptance of new devices.
CE marking is mandatory, irrespective of whether the medical device was manufactured within or outside the EEA. The responsibility of obtaining and placing the CE mark on the medical device falls on the manufacturer, and if the product is imported from outside the European Economic Area, it is the importer within the community on whom the responsibility lies.
How to obtain CE Marking
To obtain CE marking for a medical device, the product must meet the requirements of the Medical Devices Directive (MDD) for which the manufacturer needs to carry out one of four conformity assessment procedures depending upon the class of their medical device. The conformity assessment route adopted depends on the classification of the medical device. The medical devices are classified into four risk classes as being Class I, Class IIa, Class IIb, or Class III, with class I representing the lowest risk and Class III representing the highest.
Once the appropriate Conformity Assessment Procedure is selected, the manufacturer must follow the following steps:
The Technical File
The technical documentation is prepared for all classes of devices and depends upon the selected Conformity Assessment Procedure of the product. The purpose is to document the characteristics of the product including the design, manufacture, and intended operation of the product based on the relevant requirements of the Medical Devices Directive.
Declaration of Conformity
On completion of the technical documentation, the device needs to be registered with the appropriate Competent Authorities by the manufacturer through signing and keeping a declaration of conformity of the product with the essential requirements of the Directive. For Class I devices, self-declaration by the manufacturer will do, for manufacturers of Class IIa devices, in addition to self-declaration, a Notified Body has to provide a conformity assessment of the product. In the case of a Class IIb device, it either needs an audit of the full quality assurance system of the product or an “Annex III examination” along with one of the conformity assessments for Class IIa devices provided by the Notified Body. The assessment procedure for Class IIb devices is similar to Class IIb devices. However, if the full quality assurance system audit is performed by a Notified Body, then a design dossier for examination also needs to be submitted.
Final Steps to CE mark
Once a device-specific CE Certificate is received from a Notified Body (Class I devices are exempt to receive a certificate from a Notified Body), the manufacturer may affix the CE mark on the product that is easily visible, readable, and permanent and put their device on the market.
The Medical Device Consulting experts of Operon Strategist provide comprehensive Testing and Certification services and guidance to help you obtain CE Marking for your medical device for EU marketing.
