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Machinery Directive: What Applys to Medical Devices?

    https://www.johner-institute.com/articles/product-development/and-more/the-machinery-directive-which-parts-apply-to-medical-devices/
    “Devices that are also machinery within the meaning of point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (35) …

Is Your Medical Device a Machine? Guidance on the …

    https://www.intertek.com/medical/machinery-directive-paper/
    Guidance on the New Machinery Directive 2006/42/EC. The new Machinery Directive 2006/42/EC now also includes medical devices! As a manufacturer you must now take …

Directive 2006/42/EC - new machinery directive | Safety …

    https://osha.europa.eu/en/legislation/directives/directive-2006-42-ec-of-the-european-parliament-and-of-the-council
    This Directive aims at the free market circulation on machinery and at the protection of workers and consumers using such machinery. It defines essential health …

Guide to application of the Machinery Directive 2006/42/EC

    https://osha.europa.eu/en/legislation/guidelines/guide-application-machinery-directive-200642ec
    This is the second edition of the guide to the application of the revised Machinery Directive (2006/42/EC). Directive 2006/42/EC aims the harmonisation of the …

Understanding the Machinery Directive …

    https://www.intertek.com/uploadedFiles/Intertek/Divisions/Commercial_and_Electrical/Media/PDF/Industrial/Guidance-Machinery-Directive.pdf
    Understanding the Machinery Directive (2006/42/EC) construction, and they specify particular aspects of the required associated documentation needed for conformity. Even …

COCIR Recommendation Applicability of EHSR of the …

    https://www.cocir.org/media-centre/position-papers/article/cocir-recommendation-applicability-of-ehsr-of-the-machinery-directive-2006-42-ec-to-medical-devices.html
    According to the Medical Device Regulation (MDR), medical devices that are also machinery shall also meet the Essential Health & Safety Requirements (EHSR) …

EUROPA - European Commission - Growth - Regulatory …

    https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=295309&version_no=30
    *MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery *MDS 7006 - Medical devices in sterile condition: Including aseptic processing, ethylene oxide …

Machinery Directive 2006/42/EC: the Definitive Guide

    https://cemarking.net/eu-ce-marking-directives/machinery-directive/
    What is the Machinery Directive 2006/42/EC? The Machinery Directive is a European Union directive concerning machinery and certain parts of machinery: mandatory specifications in health and safety are combined …

Ultimate Guide to Machinery Directive Compliance …

    https://instrktiv.com/en/machinery-directive/
    The Machinery Directive 2006/42/EU is a European Directive and falls within the scope of CE marking. It sets requirements for machines, safety components, lifting accessories …

Machinery Directive 2006/42/EC - Manualise

    https://www.manualise.com/en/blog/law-and-legislation/machinery-directive/
    Next to requirements regarding the design, the Machinery Directive also states demands regarding the documentation. This blog lists the requirements from the Machinery Directive on the manual. Please …



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