Glossary

• A
• B
• C
• D
• E
• F
• G
• H
• I
• J
• M
• N
• P
• Q
• R
• S
• T
• U
• W

A

AAMI

Association for the Advancement of Medical Instrumentation

ABP Regulation

Animal Bi-Product Regulation 1774/2002 (SANCO)

AFSSAPS

Agence Française de Sécurité Sanitaire des Produits de Santé

AIMD

Active Implantable Medical Device Directive 90/385/EEC

ATP

Advanced Therapy Product

B

BfArM

Bundesinstitut für Arzneimittel und Medizinprodukte (Germany)

BP

British Pharmacopoeia

BSE

Bovine Spongiform Encephalopathy

BSI

British Standards Institute

C

CA

Competent Authority

CAB

Conformity Assessment Body

CDRH

US Food and Drug Administration – Center for Devices and Radiological Health

CEN

Comité Européen de Normalisation

CENELEC

Comité Européen de Normalisation Electrotechnique

CETF

Clinical Evaluation Task Force

CFU

Colony Forming Unit

COCIR

European Coordination Committee of the Radiological and Electromedical Industry

Cordis

Community Research & Development Information Service

CTS

Commission Decision 2002/364/EC, Common Technical Specifications for in vitro diagnostic medical devices

D

DA

Designating Authority

E

EDMA

European Diagnostics Manufacturers Association

EDQM

European Directorate for the Quality of Medicines

EFTA

European Free Trade Association

EMEA

European Medicines Agency

EP

European Pharmacopoeia

ER

Essential Requirements

ETSI

European Telecommunications Standards Institute

Eucomed

The European Medical Technology Industry Association

Eudamed

European Databank on Medical Devices

EUROM VI

European Federation of Precision Mechanical and Optical Industries – Medical Technology

F

FDA

United States Food and Drug Administration

FIDE

Federation of the European Dental Industry

G

GCP

Good clinical practice

GHTF

Global Harmonisation Task Force

GLP

Good laboratory practice

GMDN

Global Medical Device Nomenclature

GMP

Good manufacturing practice

H

hTEP

Human Tissue Engineered Product

I

ICH

International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use

IDABC

Interoperable Delivery of European eGovernment Services to public Administrations, Businesses and Citizens

IP

International Pharmacopoeia

ISO

International Organisation for Standardization

ISO 13485

Quality Management System Standard– Medical Devices

IVD

In Vitro Diagnostic medical device

J

JCTLM

Joint Committee for Traceability in Laboratory Medicine

JIP

Joint Implementation Plan (MRA)

M

MDD

Medical Devices Directive, 93/42/EEC

MDEG

Medical Devices Expert Group

MEDDEV

Commission Guideline relating to medical devices Directives

MedDRA

Medical Dictionary for Regulatory Activities

MHLW

Ministry of Health, Labour and Welfare (Japan)

MHRA

Medicines and Healthcare Products Regulatory Agency (UK)

MRA

Mutual Recognition Agreement

MS(s)

Member State(s)

MSOG

Market Surveillance Operations Group

N

NB-MED

European Coordination of Notified Bodies – Medical Devices

NBOG

Notified Body Operations Group

NBRG

European Coordination of Notified Bodies – Medical Devices Recommendation Group

P

PECA

Protocol to the European agreement on Conformity assessment and Acceptance of industrial products

PVC WG

Polyvinylchloride Working Group

Q

QA

Quality Assurance

QC

Quality Control

R

RAPS

Regulatory Affairs Professionals Society

S

SAE

Serious Adverse Event

SMEs

Small and medium size enterprises

SRM

Specified Risk Material

T

TBT Committee

World Trade Organization Technical Barrier to Trade Committee

TGA

Therapeutic Goods Administration (Australia)

TSE

Transmissible Spongiform Encephalopathies

TÜV

Technischer Überwachungsverein

U

UEAPME

European Association of Craft, Small and Medium-sized Enterprises

USP

United States Pharmacopoeia

W

WG

Working Group

WHO

World Health Organization

WTO

World Trade Organization