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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 ...
Placing a Medical Device into the European market is contingent upon compliance with the Medical Device Directive (93/42/EEC). While this directive applies in all member states of the European Union, each member state has its own way of implementing the directive within their country, essentially adding regulations to the directive and creating local legislation.
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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
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 marking has been introduced by the COUNCIL DIRECTIVE 93/68/EEC of 22 July 1993 amending Directives 87/404/EEC (simple pressure vessels), 88/378/EEC (safety of toys), 89/106/EEC (construction products), 89/336/EEC (electromagnetic compatibility), 89/392/EEC (machinery), 89/686/EEC (personal protective equipment), 90/384/EEC (non-automatic ...
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English: These Regulations contain the legislative measures necessary for the implementation of three European Community Directives- Council Directive 90-385-EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93-42-EEC concerning medical devices, as amended; and Directive 98-79-EC of the European Parliament ...
The so-called "murder hornet" has been eradicated from the United States, five years after the invasive species was first discovered in Washington state, officials declared Wednesday. There have ...