CE Mark and EU Medical Device Regulations
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).
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,
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