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Not all products are required to bear CE marking, only the products that fall within the scope of at least one of the sectoral norms (directives and regulations) requiring CE marking. There are more than 20 sectoral product norms requiring CE marking covering, but not limited to, products such as electrical equipment, machines, medical devices ...
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...
As clarified in the Medical Devices Directive — Directive 93/42/EEC [4] — it is required that alongside the CE mark all products must also have an Authorised Representative. As stated in this amendment, an Authorised Representative should serve as a contact point with the EU member states competent authorities.
CE Mark. A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations.
St. Jude Medical Announces CE Mark Approval of Next-Generation Ellipse and SJM Assura High Voltage Devices Next-generation implantable defibrillators feature additional safety features to elevate ...
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
Illumina Applies CE Mark to Expanded MiSeqDx™ System New Application Facilitates Development of Diagnostic Tests SAN DIEGO--(BUSINESS WIRE)-- Illumina, Inc. (NAS: ILMN) today announced that it ...
BD (BDX) receives CE mark for its rapid, point-of-care, SARS-CoV-2 antigen test for use on the BD Veritor Plus System.