notified body


Also found in: Acronyms.

notified body

A private institution charged by a competent authority with verifying compliance of medical devices (not drugs) with the applicable Essential Requirements stated in the Medical Devices Directive; this process, called Conformity Assessment, has EU-wide validity once completed by the notified body.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.
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ECM (Ente Certificazione Macchine) is an experienced and professional Notified Body (NB) (#1282) and an accredited ISO 13485 Certification Body with a broad portfolio for medical device and other industries.
An electrical product bearing G Mark indicates that it has been evaluated by a notified body such as SIRIM QAS International to comply with the essential safety requirements and electromagnetic requirement stipulated in the Gulf Technical Regulation for Low Voltage Electrical Equipment and Appliances Compatibility.
The frequency of evaluation should align with the notified body audits and renewals.
There may, however, be cases when the product will no longer be marketable as a Medical Device at all (e.g., if it contains probiotics, or if due to its nature it seems unlikely that a notified body will register the product as such in view of the stricter interpretation of the regulations).
When the United Kingdom officially "secedes" from the EU on March 30, 2019, all previously issued British Notified Body certificates on European regulations and/or directives will become void.
As an officially recognized Notified Body, TUV Rheinland can guide customers and provide the testing and documentation they need to successfully jump into the Gulf region," remarked Andreas Leo Hoefer, the executive VP for Asia Pacific / India, Middle East & Africa for TUV Rheinland.
They also state that a member state should only designate a notified body after a "joint assessment" conducted with experts from the Commission and other member states, and emphasise that the evaluation reports should be made available to all EU countries.
Fortress' mGard range of safety interlocks has achieved approval from TUV SUD*, the leading international Notified Body for the certification of safety components.
FORTRESS' mGard range of safety interlocks has achieved approval from TUV SUD, a leading international Notified Body for the certification of safety components.
Once the notified body is satisfied, they issue a design certificate that allows the manufacturer to apply the CE mark so that the test can be made available for sale throughout the European Union.
In some instances, certain machines require a Notified Body to issue a Certificate of Conformity before the machine can be legally used inside the EEA.