Acronyms

TGA

Therapeutic Goods Administration (Australia)

TOR

Term of Reference

TSE

Transmissible Spongiform Encephalopathy

UDI

Unique Device Identification

BSE

Bovine Spongiform Encephalopathy

CA

Competent Authority

CAB

Conformity Assessment Body

CIE

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*).

COCIR

European Coordination Committee of the Radiological and Electro-medical Industry

COEN

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).

CTS

Common Technical Specifications

DA

Designating Authority

EDMA

European Diagnostics Manufacturers Association

EMEA

European Medicines Agency

EUCOMED

The European Medical Technology Industry Association

EUDAMED

European Databank on Medical Devices

FDA

United States Food and Drug Administration

FSCA

Field Safety Corrective Action

FSN

Field Safety Notice

GHTF

Global Harmonisation Task Force

GMDN

Global Medical Device Nomenclature

IFU

Instructions For Use

IVD

In vitro diagnostic medical device

IVDD

In Vitro Diagnostic Medical Device Directive 98/79/EC

MD

Medical Device

MDD

Medical Devices Directive, 93/42/EEC

MDEG

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

MEDDEV

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

MRA

Mutual Recognition Agreements

NB-MED

European Coordination of Notified Bodies

NBOG

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

NCAR

National Competent Authority Report on serious adverse incident

NET

New & Emerging Technologies Working Group

AIMD

Active Implantable Medical Device

AIMDD

Active Implantable Medical Device Directive 90/385