Glossary

With our glossary you have quick access to the most important topics and explanations of technical terms, regulatory contexts and keywords.

A

Accessory for a medical device

Accompanying product information

Accreditation

Active device

Adverse event

Audit

B

Benefit-risk determination

Biocompatibility

Biocompatibility Assessment

Borderline Products

Bug

C

Case studies

Case Study for HMV-Listing

CE

CE mark

CE marking of conformity

CH – REP

Classification

Clinical benefit

Clinical data

Clinical evidence

Clinical investigation plan

Clinical performance

Common specifications (CS)

Compatibility

Conformity

Conformity assessment

Conformity assessment body

Conformity assessment procedure

Consignment warehouse

Contract Research Organisations (also known as Clinical Research Organisations) – CROs

Corrective action

Custom-Made Device

D

Declaration of Conformity

Device deficiency

DiGA and DiPA

Digital healthcare applications (DiGA)

Distributor

E

EC Declaration of Conformity

Economic operator

Electromagnetic compatibility (EMC)

EMA

EN ISO 13485

Ethics committee

EU-REP

EUDAMED

F

Failure Mode and Effects Analysis (FMEA)

Falsified device

FDA – Food and Drug Administration (USA)

Federal Communications Industry Association (Bundesverband Industrie Kommunikation e.V. – BVIK)

Federal Gazette (Bundesanzeiger)

Federal Joint Committee (Gemeinsamer Bundesausschuss – G-BA)

Field safety corrective action

Field safety notice

Full refurbishment

G

General safety and performance requirements according to MDR

Generic device group

German Act on the Provision of Therapeutic Products and Medical Devices (Heil-und Hilfsmittelversorgungsgesetz – HHVG)

German Federal Ministry of Health (Bundesministerium für Gesundheit – BMG)

German Institute for Medical Documentation and Information (Deutsches Institut für Mendizinische Dokumentation und Information (DIMDI)

German Medical Device Operators Ordinance (Medizinprodukte – Betreiberverordnung – MPBetreibV).

German Medical Devices Act (Medizinproduktegesetz – MPG)

German Medical Devices Safety Ordinance (Medizinprodukte-Sicherheitsverordnung– MPSV)

German Medical Technical Aids Register (Hilfsmittelverzeichnis – HMV)

German Medical Technology Association (Bundesverband Medizintechnologie – BVMed)

German National Association of Statutory Health Insurance Funds (GKV Spitzenverband)

German Specialist Association for Medical Devices (Fachvereinigung für Medizinprodukte)

Global Medical Devices Nomenclature (GMDN)

Good Manufacturing Practice (GMP)

H

Harmonised standard

Health institution

HMV Representative

HMV-Updates

i

Ifa GmbH

Implantable device

Importer (MDR)

Incident

Informed consent

Initial importer (FDA)

Instructions for use

Intended use

Interoperability

Invasive Product

Investigational device

Investigator

IVD

L

Label

M

Maintenance CE-Documentation

Maintenance QM-Documentation

Making available on the market

Manufacturer

Market surveillance

Market Surveillance according to MDR

MDCG – Medical Device Coordination Group

MDEL – Medical devices establishment licence listig

MDR – Medical Device Regulation

Medical aids

Medical benefit

Medical Device

Medical Device Advisor Training

Medical device registration number (Hilfsmittelnummer)

Medical Devices (MEDDEV) documents

Medical Devices Adviser (Medizinprodukteberater)

Medical Devices Directive (93/42/EEC)

MPSV – Medizinprodukte-Sicherheitsverordnung

N

Non-viable

Notified body

O

Original Equipment Manufacturer (OEM)

P

Performance

Person Responsible for Regulatory Compliance (PRRC)

Pharmaceutical registration number (Pharmazentralnummer – PZN)

Placing on the market

Post-market surveillance

Pre-qualification

Procedure pack

Processing

Product Groups in the HMV

Putting into service

QM logs

Q

QM Processes

QM-Workshop

Quality Audit

Quality Management Documents

Quality Management Records

Quality Manager (QMB)

Quality Manual

Quality Records

R

Recall

Registration

Registration system

Rehadat (REHADAT)

Request for official statement (Anhörungsschreiben)

Responsible authority

Risk

Risk analysis

Risk assessment

Risk management

S

Serious adverse event

Serious incident

Serious public health threat

Single-use device

Software validation (SV)

Sponsor

Standard operating procedure (SOP)

Start-Up Package

Statutory Health Insurance’s Obligation to Provide Benefits

Subject

Suitability for use

Summary TEchnical Documentation (STED)

Swiss Devices and Items List (Mittel und Gegenständeliste) – MiGEL

System

T

Technical Documentation

Tests

The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, – BfArM)

Traceability

UMDNS – Universal Medical Device Nomenclature System

Unique device identifier (UDI)

US-Agent

Usability Assessment

User

W

Withdrawal

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