This page provides a list of confusing terms that trouble even the best of us. We hope that this glossary provides some insight into the world of EU regulatory Compliance.
Center for Devices and Radiological Health, FDA.
CE Marking Approval marking for products being shipped into the 27 countries of the European Union. Products bearing the CE Marking represent products that meet all applicable New Approach Directives.
European Association of Authorized Representatives EEIG (European Economic Interest Grouping).
European Economic Community (also known as the Common Market). Originally consisted of 6 member countries: France, Germany, Italy, Belgium, the Netherlands and Luxembourg. By 2007 it included all the EU member countries.
European Free Trade Association. As of today, Norway, Iceland and Liechtenstein are the remaining EFTA countries. Austria, Finland and Sweden have joined the EU, and Switzerland has dropped out. On October 21st 1991, the EC and EFTA reached an Agreement that included the principles of free movement of goods, services, capital and people.
The standard to which the Medical Notified Bodies will audit. Includes ISO 9000 (or EN 29000) and specific medical requirements
European Union. A regional economic and political organization with a combined GDP of more than $ 16 trillion and a population of 502 million. Its 27 member countries include : Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.
One of the European Union’s Institutions. The Commission is responsible for proposing policy and legislation. It is the guardian of all European treaties and laws and can initiate action against a member state who does not comply with EU rules.
Environmental Management and Audit System. An environmental standard that many EU companies have implemented in their business.
One of the EU’ s New Approach Directives covering Electromagnetic Compatibility. Provides protection (immunity) to electronic equipment from interference (emissions) from other electronic equipment. An example of interference would be when a television set produces electronic waves (“fuzz”) on the tube when a vacuum cleaner or blow dryer is running close by. Products needing to meet this Directive had to do so by January 1st 1996.
International Organization for Standardization. A worldwide federation of National Standard Bodies, founded in Geneva, Switzerland in 1946.
Series of International Standards that form the foundation and framework for an effective management system within any type of business.
Known also as BS 7750. It is an International Standard covering environmental issues and concerns, such as air emissions, water discharge, wastes, noise, odor, etc.
In Vitro Diagnostic Medical Device means any medical device which is reagent, reagent product, calibrator, control material, kit instrument, apparatus, equipment, or system whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning physiological or pathological state, congenital abnormality or to determine the safety and compatibility with potential recipients or to monitor therapeutic measures.
IVD for Performance Evaluation
Any device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analysis or in other appropriate environments outside his own premises.
IVD for self-testing
Any device intended by the manufacturer to be able to be used by lay persons in a home environment.
Medical Device means any instrument, apparatus, appliance, material or other article, whether use alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of : diagnosis, prevention, monitoring, treatment, alleviation of disease, or diagnosis, monitoring, treatment, alleviation of a compensation for an injury or an handicap, or investigation, replacement or modification of the anatomy of a physiological process, or control of conception.
MD Class I
General unpowered (non-active) devices which do not penetrate the body or non-surgically invasive devices for transient use (less than 60 minutes). Some low risk, powered (active) devices for patient support or examination.
MD Class IIa
Generally non-hazardous active therapeutic and diagnostic devices. Low risk, surgically invasive devices for transient use or short terms use (up to 30 days).
MD Class IIb
Generally potentially hazardous active therapeutic and diagnostic devices (e.g. X-ray sources). Higher risk surgically invasive devices for transient or short term use. Surgically invasive devices for long term or implantable (non-active) use (up to 30 days).
MD Class III
All devices which make contact with the heart, central circulatory system or central nervous system. All long term invasive or implantable devices which have biological effect on the body or are absorbed into it.
Medical Device Directive
One of the New Approach Directives covering Medical Devices, includes the Safety, Health and Quality requirements of Medical Devices to protect patients, operators and others using or exposed to a Medical Device.The deadline for meeting this Directive was June 15th 1998.
Certified Organization appointed by the EU member countries to perform formal audits of products and quality systems for many of the EU’ s New Approach Directives. A Notified Body is appointed to a particular Directive. For example, a Notified Body for MDD may not necessarily be a Notified Body for Low Voltage Directive (LVD) as well.
Technical Construction File
One of the conformity assessment routes for meeting the requirements of the EMC Directive. It is the manufacturer’s responsibility to compile the relevant documentation, even if the manufacturer is not in the BC. This TCF must be kept within the BC territory (“Authorized Representative”) for inspection purposes for a period of not less than 10 years after sale of the product. The Technical File together with the Certificate issued by an EU appointed “Competent Body” provides the enforcement authorities with the means of assessing the conformity of the requirements of the Directive.
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