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B COUNCIL DIRECTIVE 93/42/EEC of 14 June …
- https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF
- COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the …
EUR-Lex - 31993L0042 - EN - EUR-Lex - Europa
- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042
- Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive …
Council Directive 93/42/EEC of 14 June 1993 concerning …
- https://www.legislation.gov.uk/eudr/1993/42/2020-12-31
- Whereas this Directive should include requirements regarding the design and manufacture of devices emitting ionizing radiation; whereas this Directive does not …
MEDICAL DEVICES Guidance document …
- https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations/en/renditions/native
- Conformity assessment is the method by which a manufacturer demonstrates that their devices comply with the requirements of Directive 93/42/EEC. The classification of the …
Medical Device Directive 93/42/EEC | Medcert
- https://www.med-cert.com/en_ce-marking/en_medical-device-directive-9342eec/
- The involvment of a Notified Body is necessary for all medical devices, except for class I medical devices (non-sterile or without a measuring funtion). Scope. The Directive …
Medical Device Directive (MDD), Directive 93/42/EEC - Lexparency
- https://lexparency.org/eu/31993L0042/
- ANNEX VI — EC DECLARATION OF CONFORMITY ANNEX VII — EC DECLARATION OF CONFORMITY ANNEX VIII — STATEMENT CONCERNING …
Medical Devices Directive 93/42/EEC - CE Marking
- https://cemarking.net/eu-ce-marking-directives/medical-devices-directive/
- EU Declaration of Conformity. Medical Devices Directive. Medical Devices Directive. Number:93/42/EEC. Official Title: Council Directive 93/42/EEC of 14 June 1993 …
Guide to Medical Device Directive Compliance …
- https://instrktiv.com/en/medical-device-directive/
- This directive covers a number of devices which are used for diagnosis, monitoring, and treatment of individuals. Medical devices have been divided by the MDD into the following …
Medical Devices Directive 93/42/EEC is due …
- https://www.cti-cem.com/blog/medical-devices-directive-93-42-eec/
- The Directive excludes any products which come within the scope of one of the other two medical device directives. The Medical Devices Directive has a very wide scope …
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