Medical Devices Directive 2007

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21.9.2007 EN Official Journal of the European Union …

https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:247:0021:0055:en:PDF

of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive …

EUR-Lex - 32007L0047 - EN - EUR-Lex - Europa

https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32007L0047

‘“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its …

Directive 2007/47/EC of the European Parliament and of …

https://www.legislation.gov.uk/eudr/2007/47/contents

Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member …

Medical Device Directive (MDD), Directive 2007/47/EC - Lexparency

https://lexparency.org/eu/32007L0047/

Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member …

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 65/65/EEC; …

Medical Device Directive (MDD)

https://www.medicaldevicesgroup.net/medical-device/MDD_Training_D7-1.pdf

There are four device classifications: – Class I – Class IIa – Class IIb – Class III. Class I devices, that are non- sterile and non-measuring, do not require a Notified Body (NB). All …

ANNEX IX Medical Device Directive - CLASSIFICATION …

https://lexparency.org/eu/31993L0042/ANX_IX/

ANNEX IX Medical Device Directive - CLASSIFICATION CRITERIA ANNEX IX — CLASSIFICATION CRITERIA I. DEFINITIONS 1. Definitions for the classification rules …

Medical Devices Directive - Wikipedia

https://en.wikipedia.org/wiki/Medical_Devices_Directive

The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 [1] concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws …

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

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042

Whereas this Directive covers the medical devices referred to in Council Directive 76/764/EEC of 27 July 1976 on the approximation of the laws of the Member States on …

Medical devices - Internal Market, Industry, Entrepreneurship and …

https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards/medical-devices_en

Commission Implementing Decision (EU) 2021/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the …

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