Kirk Zeller , DBA

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CE Mark and EU Medical Device Regulations
CE Marking is a requirement for marketing many products including medical devices. This is required under the European Union’s New Approach Directives. CE Marking indicates a manufacturer’s claim that their product meets the requirements of all essential European Directives (BSI 2005) (Kinsbergen 2000). CE Mark products can be sold in all EU markets and there are no national or local approvals required (Kinsbergen 2000). The CE Mark provides an assurance that manufacturers have taken all measures necessary to ensure the safety and efficacy of the products is in compliance with the relevant directive (Smith 1996).

Medical devices are subject to three specific European CE Marking Directives:
1) Medical Device Directive (MDD)
2) Active Implantable Medical Device Directives (AIMDD)
3) In Vitro Diagnostic Directive (IVDD)

The approval of a medical device for sale in the European Union is done via the CE mark approval process through a Notified Body (NB). Notified bodies are certification organizations that have approval from the national authority that oversees certification. Class IIa, Class IIb, and Class III devices all require that a notified body certification (Kinsbergen 2000). The process of obtaining a CE mark for the regulatory clearance class III products requires submission of the results of bench testing, animal testing, clinical testing, labeling, and fulfillment of other quality requirements.

In the European Union medical devices are divided into four classes: Class I, Class IIa, Class IIb, and Class III. Class is determined based on the degree of invasiveness and duration of use, with Class III devices being subject to the most stringent requirements.

Copyright © 2004 Kirk Zeller, All rights reserved