CE Marking

CE Marking is the regulatory framework used in the European Union. This pearltree is a collection of resources that will be helpful to regulatory professionals, product safety engineers or anyone tasked with implementing the EU regulatory framework in business.

Need help with understanding this material? Contact Doug Nix at dnix at complianceinsight dot ca, +1 519 729 5704. You can get more guidance from our blog, CE mark, CE marking, CE certification, CE approval, CE standards, CE Directive, CE requirements - CEMarking.Net. Legislation. Consumer Affairs - Safety - Rapid Alert System for non-food products posing a serious risk (RAPEX) Rapid Alert System for non-food dangerous products RAPEX is the EU rapid alert system that facilitates the rapid exchange of information between Member States and the Commission on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers –with the exception of food, pharmaceutical and medical devices, which are covered by other mechanisms.

Since 1 January 2010, as regards goods subject to EU harmonisation regulation, the system also facilitates the rapid exchange of information on products posing a serious risk to the health and safety of professional users and on those posing a serious risk to other public interests protected via the relevant EU legislation (e.g. environment and security). Both measures ordered by national authorities and measures taken voluntarily by producers and distributors are reported by RAPEX. How does RAPEX work? Find herewith the list of National Contact Points Updated 13-05-2013 To Top.

General Directives

CE Marking Guidance. Directives As a first step, you need to verify whether your product(s) fall(s) within the definition of an active implantable medical device in accordance with Article 1 paragraph 2a) to c) of Directive 90/385/EEC where also the term "active medical device" is defined. For a definition of "implantable device" see Annex IX, section I.1.2 of Directive 93/42/EEC on medical devices. Secondly, you need to verify that none of the exclusion clauses of Article 1 paragraph 3 to 6 is applicable. If all these conditions are fulfilled, Directive 90/385/EEC applies. As a first step, you need to verify whether your product(s) fall(s) within the definition of a medical device in accordance with Article 1 paragraph 2a) of Directive 93/42/EEC.

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ATEX

SPV. PED. EMC. Low Voltage. Machinery. Medical Devices.