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 Glossary 

firstbase connects sender and receiver of product master data. 

Here you will find a glossary. 

AIMDD

The Active Implantable Medical Devices Directive (AIMDD) is the Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) [European market].

API

An API (Application Programming Interfaces) is an interface that allows independent applications to communicate with each other and exchange data. With the help of APIs, products or services can communicate with each other regardless of their implementation. In this way, application development can be optimised, which in turn saves time and money.

CH-REP

Swiss authorised representative (CH-REP)

With the amendment of the Medical Devices Ordinance (MepV, SR 812.213) in the context of pending agreements between Switzerland and the EU, the role of the authorised representative for medical device manufacturers based outside Switzerland was introduced.

CHRN

Swiss Single Registration Number (CHRN)

The CHRN is a unique Swiss registration number which enables the unambiguous identification of manufacturers, authorised representatives and importers established in Switzerland and Liechtenstein.

Based on the Medical Devices Ordinance (MepV; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDV; SR 812.219), Swissmedic allocates the CHRN.

EUDAMED

The European Database on Medical Devices (EUDAMED) is a database operated by the European Commission and EU Member States for the centralised management of medical devices, developed as an integral part of the implementation of the MDR and IVDR. It aims to increase transparency about medical devices, provide better access to information for the public and healthcare professionals, and improve coordination between EU Member States. The system provides an up-to-date picture of the life cycles of medical devices available in the EU.

With the fristbase healthcare Connector, data can be maintained in firstbase and registered in EUDAMED.

GDSN

The GS1 Global Data Synchronisation Network (GDSN) is the largest product data network in the world.

GS1 GDSN® enables any company in any market to seamlessly exchange high value product information.

GTIN

The GTIN (short for Global Trade Item Number) is the 13-digit number below the barcode. It can be used to identify every article, every product or every product variant worldwide without overlapping. It is often also called the article number and functions as an access key to product information stored in databases, such as designation, container size or dimensions.

GUDID

The Global Unique Device Identification Database (GUDID) is a database managed by the US Food and Drug Administration (FDA) for the registration of medical devices.

With the fristbase healthcare Connector, data can be maintained in firstbase and registered in the GUDID.

H+ The Hospitals of Switzerland

H+ is the national umbrella organisation of public and private Swiss hospitals, clinics and care institutions.

H+ is also on the steering committee of firstbase healthcare and supports firstbase as an industry solution for the Swiss healthcare sector.

HCI

HCI Solutions is a provider of solutions around medication, data on medicines and healthcare products in the Swiss healthcare market.

HIBCC

The Health Industry Business Communications Council (HIBCC) is one of four allocation bodies for a UDI in the European region.

ICCBBA

The International Council for Commonality in Blood Banking Automation (ICCBBA) is one of four allocation bodies for a UDI in the European area.

IFA

The Information Centre for Proprietary Medicinal Products (IFA GmbH) is one of four allocation bodies for a UDI in the European area.

Importeur

Importer refers to the role resulting from the activity carried out when a natural or legal person (in Switzerland) places a product from abroad on the Swiss market.

IVDD

The In-Vitro Diagnostic Devices (IVDD) is Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [European market].

IVDR

The In Vitro Diagnostic Device Regulation (IVDR) is Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU [European market].

LIR

Dutch Implant Registry (LIR)

With the fristbase healthcare GS1 GDSN® Connector, data can be maintained in firstbase and registered in the LIR.

IvDV

The Ordinance on In Vitro Diagnostics (IvDV) is the regulation that applies in Switzerland to in vitro diagnostic medical devices and their accessories.

MDD

The Medical Device Directive (MDD) is Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [European market].

MDR

The Medical Device Regulation (MDR) is Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC [European market].

MDR-Risikoklassen

Medical devices, with the exception of in vitro diagnostic medical devices, are assigned to risk classes. Medical devices that fall under the Medical Devices Ordinance must in turn be assigned to one of the following classes: Class I [Class I medical devices with a measuring function (Im); Class I sterile medical devices (Is);

Reusable surgical instruments of class I (Ir)], class IIa, class IIb, class III.

Unlike medicinal products, medical devices do not undergo official authorisation. For these products, Switzerland relies on the requirements for the conformity assessment or certification system from the European Union (EU). Conformity with the internationally applicable standards is assessed by private bodies.

MepV

The Medical Devices Ordinance (MepV) is the regulation that applies in Switzerland to medical devices and their accessories, as well as product groups without a medical purpose according to Annex 1.

NHS

The United Kingdom National Health Service (NHS) is the public health system in Great Britain and Northern Ireland.

With the fristbase healthcare GS1 GDSN® Connector, data can be maintained in firstbase and registered in the NHS.

refdata

The refdata foundation has set itself the goal of unambiguously identifying articles and the organisations and persons involved in the healthcare system in Switzerland and referencing them in publicly accessible databases. In this way, refdata not only enables an increase in patient safety, but also provides the actors in the value chain with the keys to greater efficiency, effectiveness, transparency and safety.

refdata is also on the steering committee of firstbase healthcare and supports firstbase as an industry solution for the Swiss healthcare sector.

SRN

The Single Registration Number (SRN) is the unique number that allows the unambiguous identification of each economic operator in the European Database for Medical Devices (EUDAMED). It is assigned to each economic operator upon registration in EUDAMED after the national authority has validated the address data.

swissdamed

The swissdamed (short for Swiss Database on Medical Devices ) will be the Swiss counterpart to EUDAMED - the European Database on Medical Devices. The database will enable the registration of economic operators and products in two interconnected modules. With a corresponding amendment to the MepV / IvDV, the registrations will become mandatory.

A fristbase healthcare Connector, with which data can be maintained in firstbase and registered in swissdamed, is being planned.

Swiss Medtech

The swissdamed (short for Swiss Database on Medical Devices ) will be the Swiss counterpart to EUDAMED - the European Database on Medical Devices. The database will enable the registration of economic operators and products in two interconnected modules. With a corresponding amendment to the MepV / IvDV, the registrations will become mandatory.

A fristbase healthcare Connector, with which data can be maintained in firstbase and registered in swissdamed, is being planned.

UDI

Unique Device Identification (UDI) for medical devices.

The UDI is a unique numeric or alphanumeric code for a medical device. It enables clear and unambiguous identification of specific products on the market and facilitates their traceability with the aim of increasing patient safety.

Web-UI

A Web User Interface (Web UI for short) is a graphical user interface through which a user can interact with a system using a web browser.

Economic operator

An economic operator is a natural or legal person (organisation) with a specific role ("manufacturer", "authorised representative", "importer" or "manufacturer of system and treatment units") that must be registered in EUDAMED or swissdamed.

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