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An authorised representative may also carry out a conformity assessment of a medical device on behalf of the manufacturer. [ 7 ] European ‘Blue Guide" [ 8 ] describes that delegation of an authorised representative should be set out in writing (as an agreement, mandate, or power of attorney) to define contents and limits of tasks.
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 It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
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.
Eucomed was the organisation that represented the interests of the medical device industry in Europe. [1] It represents directly and indirectly 4,500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and management of disease and disability. [2]
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 ...
China and the EU last year agreed on a need for "balanced" trade ties and discussed medical devices, cosmetics and geographical indicators for food products to redress trade imbalances.
Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC (IVDD), which also concerned IVD. The regulation was published in April 2017 and is closely aligned to the EU regulation on medical devices.
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