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Compliance Engineering
News Release from: UL International (UK) | Subject: Class III active medical device certification
Edited by the Electronicstalk Editorial
Team on 03 August 2007
Medical device certification expands
Class III active medical devices are a relatively small but important segment of the medical device markets.
Underwriters Laboratories has been expanding its core capability to assess and certify manufacturers of Class III active medical devices intended for sale in the EU "This investment in expanding our scope provides UL's customers with an end-to-end solution and is another example of how we are working to fully meet the needs of active device manufacturers regardless of risk classification", says Anil Patel, General Manager of UL's Medical Business Unit
This article was originally published on Electronicstalk on 23 Mar 2005 at 8.00am (UK)
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"By broadening the 'one-stop' option for active device clients, we are facilitating certification of entire product categories across the complete range of risk classification in accordance with both US and EU market requirements".
Class III active medical devices are a relatively small but important segment of the medical device markets.
These devices are regarded as high risk primarily due to the vicinity in the human body in which they operate, such as in contact with the central circulatory system or the central nervous system.
Examples of such devices include probes introduced into the circulatory system to monitor such parameters as blood temperature and blood flow, ablation catheters used in cardiac procedures, and implanted transducer probes used to monitor heart output.
"UL is pleased to further expand our services for medical device manufacturers seeking assessment by our notified body to obtain the CE Mark and thereby gain EU market access", says Steve Buxton, Leader of UL's Medical Notified Body based in London, UK.
"We intend to pursue ongoing extension of our activities to also include certain carefully selected class III nonactive devices in support of our customer-driven regulatory certification strategy".
Medical devices classified under the MDD must be registered with a competent authority before they can be sold in the EU bearing the requisite CE Mark.
Products manufactured outside of the EU must have representation within one of the EU member states.
This is the designated authorised representative who is responsible for registering the product with one of the EU competent authorities and for acting as the local point of contact for the purposes of dealing with any incidences associated with the devices in the EU market.
MHRA is the competent authority for the UK.
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