Therapeutic Goods Administration (Australia)

Term of Reference

Transmissible Spongiform Encephalopathy

Unique Device Identification

Bovine Spongiform Encephalopathy

Competent Authority

Conformity Assessment Body

Working Group on Clinical Investigation and Evaluation - The CIE develops and promotes homogenous interpretation and implementation of the MD Directives with regard to clinical evaluation and investigation (formerly CETF [Clinical Evaluation Task Force*).

European Coordination Committee of the Radiological and Electro-medical Industry

Compliance and Enforcement Group - COEN's task is to focus on the scope and better coordination of the enforcement activities and improve the communication and co-operation between Member States (formerly MSOG).

Common Technical Specifications

Designating Authority

European Diagnostics Manufacturers Association

European Medicines Agency

The European Medical Technology Industry Association

European Databank on Medical Devices

United States Food and Drug Administration

Field Safety Corrective Action

Field Safety Notice

Global Harmonisation Task Force

Global Medical Device Nomenclature

Instructions For Use

In vitro diagnostic medical device

In Vitro Diagnostic Medical Device Directive 98/79/EC

Medical Device

Medical Devices Directive, 93/42/EEC

Medical Devices Expert Group - The MDEG is a group of Member States, industries and other stakeholders' representatives for the implementation of the MD directives.

Commission Guideline relating to medical devices directives - the MEDDEV aim at promoting a common approach by Member States, manufacturers and Notified Bodies and are carefully drafted through a process of consultation with various interested parties

Mutual Recognition Agreements

European Coordination of Notified Bodies

Notified Bodies Operations Groups - the NBOG improves processes in relation to the designation and monitoring of Notified Bodies by national authorities.

National Competent Authority Report on serious adverse incident

New & Emerging Technologies Working Group

Active Implantable Medical Device

Active Implantable Medical Device Directive 90/385