Примери за използване на In vitro diagnostic на Английски и техните преводи на Български
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five years after publication as regards in vitro diagnostic medical devices.
9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;
2017/746 shall apply to the in vitro diagnostic medical device part of the device.
the EU agreed new rules on medical devices and in vitro diagnostic medical devices.
of Regulation(EU) 2017/746 on the performance evaluation of certain in vitro diagnostic medical devices.
experience in the field of medical devices and in vitro diagnostic medical devices.
five years after publication as regards in vitro diagnostic medical devices.
Investigation of the sensitivity of in vitro diagnostic veterinary medicine means with technique of fluorescent antibody test- Detski i infectsiosni bolesti,
This proposal is adopted alongside a proposal for a Regulation on in vitro diagnostic medical devices(IVDs),
Its aim is to modernise the current legislation to make sure that medical devices and in vitro diagnostic medical devices are safe, can be traded across the EU and that new innovative devices reach patients in a timely manner.
The Commission proposals incorporate guidelines developed at international level into EU law with a view to converging the regulatory requirements for medical devices and in vitro diagnostic medical devices in major economies.
In vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation(EU)
the Permanent Representatives Committee finalised the Council's position on two draft regulations aimed at modernising EU rules on medical devices and in vitro diagnostic medical devices.
should be replaced by a single legislative act applicable to all medical devices other than in vitro diagnostic medical devices.
agreed new rules on medical devices and in vitro diagnostic medical devices.
EC directives 93/42/EEC(medical devices) and 98/79/EC(in vitro diagnostic medical devices)
Recital 7(7) The scope of application of this Regulation should be clearly delimited from other Union harmonisation legislation concerning products, such as in vitro diagnostic medical devices,
2017/746 concerning in vitro diagnostic medical devices provide for the authorisation of such devices on the basis of the principles of transparency and safety and not on efficacy.
On 19 June 2015 the Council of the European Union reached a general consensus on two draft Regulations aimed at modernising EU rules on Medical devices and In vitro Diagnostic Medical Devices.