Medical Devices Directive Dyrektywa

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EUR-Lex - 32017R0745 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/eli/reg/2017/745/oj

Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulatory framework for medical devices, other than in vitro diagnostic medical devices. However, a fundamental revision of those Directives is needed to establish a …

EUR-Lex - 31993L0042 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/PL/TXT/?uri=CELEX%3A31993L0042

dyrektywa Rady 90/385/EWG z dnia 20 czerwca 1990 r. w sprawie zbliżenia ustawodawstw Państw Członkowskich odnoszących się do wyrobów medycznych aktywnego …

EUR-Lex - 01993L0042-20071011 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A01993L0042-20071011

Whereas Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical …

EUR-Lex - 31998L0079 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:31998L0079

(b) 'in vitro diagnostic medical device` means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, …

B COUNCIL DIRECTIVE 93/42/EEC of 14 June …

https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF

medical device as a general rule is governed by the present Directive and the placing on the market of the medicinal product is governed by Directive …

MDR Rozporządzenie w sprawie wyrobów …

https://www.beurer.com/web/pl/mdr-pl.php

Rozporządzenie MDR reguluje dopuszczanie do obrotu wyrobów medycznych, takich jak ciśnieniomierze, termometry lekarskie itp., oraz zapewnia zgodność …

MEDICAL DEVICES : Guidance document

https://ec.europa.eu/docsroom/documents/10288/attachments/1/translations/en/renditions/pdf

The medical devices directives (MDD, AIMD, [draft IVD]) each require a statementgiven on the label and/or the information provided with the device on any time limitationon the …

Directives - Public Health

https://health.ec.europa.eu/medical-devices-sector/directives_en

The Medical Devices Directives establish specific procedures that national authorities must follow when considering the enforcement of the harmonised legislation. In addition, the …

Electromagnetic Compatibility (EMC) Directive

https://single-market-economy.ec.europa.eu/sectors/electrical-and-electronic-engineering-industries-eei/electromagnetic-compatibility-emc-directive_en

Electromagnetic Compatibility (EMC) Directive Electromagnetic Compatibility (EMC) Directive All electric devices or installations influence each other when interconnected or …

Stryker - Medical Devices and Equipment Manufacturing …

http://stryker.com/us/en/index.html

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