Agency dating european

It was about time to adapt the rules to technological progress, also with a view to reach a more harmonized system in a single market.

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At the same time, also a proposal for a Regulation on in vitro diagnostic medical devices to replace Directive 98/79/EC regarding in vitro diagnostic medical devices was published.MEDICAL DEVICES: on the way to improving patient safety in Europe…Industry responded with relief to latest developments affecting new legislation on medical devices: At the end of October, the European Parliament in its plenary assembly settled on a compromise that appears to lessen the expected burden on industry.A notified body conducts conformity assessments allowing manufacturers to affix the CE mark to their devices and place them on the European market.There is a general consent on the need of stricter rules to regulate the 80 notified bodies for medical devices in the European Union.But there are also many small and medium-sized companies active in the medical devices sector.


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