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CE marking example on a mobile phone charger. The presence of the logo (from French, "conformité européenne" meaning "European conformity") [2] on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards.
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.
PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYS: STJ) , a global medical device company, today announced European CE Mark approval of its ViewFlex ™ Xtra Intracardiac Echocardiography ...
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 ...
The number of approved medical devices using artificial intelligence or machine learning (AI/ML) is increasing. As of 2020, there were several hundred AI/ML medical devices approved by the US FDA or CE-marked devices in Europe. [88] [89] [90] Most AI/ML devices focus upon radiology. As of 2020, there was no specific regulatory pathway for AI/ML ...
The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of a medical device to establish a technical file (medical device file, device master record, design dossier, or device master file). Annex II and III of the EU medical device regulation (MDR) and of the In-vitro Diagnostic Regulation (IVDR) contain an overview of the contents and ...
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related to: ce marked medical devices list