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VPB 4326-2002-1490 AI generated

Swiss Ordinance on In Vitro Diagnostic Medical Devices and Common Technical Specifications

Case Number VPB 4326-2002-1490
Court / Authority
Jurisdiction Switzerland · Administrative Practice of Federal Authorities (VPB) (CH)
Decision Date
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Legislator summary

AI generated

This document specifies that, in accordance with Swiss Medical Device Ordinance (ODim) Article 4, paragraphs 2 and 3, common technical specifications (STC) are defined as essential requirements for in vitro diagnostic medical devices. These STC, issued by the European Commission, are available for order through the Swiss Association for Standardization, and the list will be updated as modifications or extensions are published in the EU Official Journal.

Legislator headnote

AI generated

Art. 4 al. 3 ODim, Art. 4 al. 2 ODim; Swiss Ordinance on In Vitro Diagnostic Medical Devices and Common Technical Specifications: These STC, issued by the European Commission, are available for order through the Swiss Association for Standardization, and the list will be updated as modifications or extensions are published in the EU Official Journal.

Keywords

AI generated
medical devices specifications medical care requirements compliance with technical standards common reporting standard type of procedure

Cited Legislation

AI generated
Art. 4 al. 3 ODim
This provision is used to define the listed specifications as common technical specifications for in vitro diagnostic medical devices.
Art. 4 al. 2 ODim
This provision is cited as the basis for the essential requirements that in vitro diagnostic medical devices must meet.
AI generated
VPB 5616-2008-1883
Harmonized European Standards for Medical Devices Ordinance
VPB 16-2008-1883
Harmonized European Standards for Medical Devices Ordinance
VPB 2002.552
Medical Devices Ordinance and Harmonized European Standards
VPB 98-2005-1997
Swissmedic Ordinance on Technical Standards for Medical Devices
VPB 4898-2005-1997
Swissmedic Ordinance on Technical Standards for Medical Devices

Key legal questions extracted by Legislator

AI generated
Art. 4 al. 3 ODim

This provision is used to define the listed specifications as common technical specifications for in vitro diagnostic medical devices.

Art. 4 al. 2 ODim

This provision is cited as the basis for the essential requirements that in vitro diagnostic medical devices must meet.

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Full text

Ordonnance sur les dispositifs médicaux (ODim)

Spécifications techniques communes des dispositifs médicaux de diagnostic in vitro

En vertu de l’art. 4, al. 3, de l’ordonnance du 17 octobre 2001 sur les dispositifs médicaux (ODim)1, les spécifications énumérées dans l’annexe sont définies comme spécifications techniques communes propres à concrétiser les exigences essentielles auxquelles doivent satisfaire les dispositifs médicaux de diagnostic in vitro au sens de l’art. 4, al. 2. Il s’agit de spécifications techniques communes édictées par la Commission des communautés européennes. Les textes de ces spécifications techniques communes peuvent être commandés auprès de l’Association suisse de normalisation (ASN), division switec, Bürglistrasse 29, 8400 Winterthur.

16 juillet 2002 Swissmedic:

Le directeur, Dr Hans Stocker

1 RS 812.213

4326 2002-1490 Annexe

Spécifications techniques communes des dispositifs médicaux de diagnostic in vitro

Edition Référence au journal Titre officiel de l’UE

2002 2002/L 131/18 STC – Spécifications techniques communes des dispositifs médicaux de diagnostic in vitro

Les spécifications techniques communes peuvent être, sur décision de la Commission des communautés européennes, modifiées et/ou étendues. A leur achèvement et publication dans le journal officiel de l’UE la présente liste sera respectivement mise à jour. Dernière mise à jour: 2002-06-25

4327 Schweizerisches Bundesarchiv, Digitale Amtsdruckschriften Archives fédérales suisses, Publications officielles numérisées Archivio federale svizzero, Pubblicazioni ufficiali digitali

Ordonnance sur les dispositifs médicaux (ODim). Spécifications techniques communes des dispositifs médicaux de diagnostic in vitro

In Bundesblatt Dans Feuille fédérale In Foglio federale

Jahr 2002 Année Anno

Band 1 Volume Volume

Heft 28 Cahier Numero

Geschäftsnummer --- Numéro d'affaire Numero dell'oggetto

Datum 16.07.2002 Date Data

Seite 4326-4327 Page Pagina

Ref. No 10 126 449

Die elektronischen Daten der Schweizerischen Bundeskanzlei wurden durch das Schweizerische Bundesarchiv übernommen.

Les données électroniques de la Chancellerie fédérale suisse ont été reprises par les Archives fédérales suisses.

I dati elettronici della Cancelleria federale svizzera sono stati ripresi dall'Archivio federale svizzero.