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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.
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 ...
Commission Directive 66/683/EEC of 7 November 1966 eliminating all differences between the treatment of national products and that of products which, under Articles 9 and 10 of the Treaty, must be admitted for free movement, as regards laws, regulations or administrative provisions prohibiting the use of the said products and prescribing the use of national products or making such use subject ...
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 ...
St. Jude Medical Announces CE Mark and Launch of First Quadripolar CRT Pacemaker Allure Quadra elevates the standard for Cardiac Resynchronization Therapy Pacemakers ST. PAUL, Minn.--(BUSINESS ...
An example of such local implementation of the Directive is now present in Italy. Italy requires, in addition to the CE marking (as opposed to the essence of the CE marking which is “Free Circulation of Goods”), that ALL Medical Devices to be placed in the Italian market will go through a Device registration process.
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