Übersetzung für "In vitro diagnostic device" in Deutsch

This version is harmonized with respect to the three European Directives associated with medical devices Medical Devices Directive 93/42/EEC, In-vitro Diagnostic Medical Device Directive 98/79/EC, and Active Implantable Medical Device Directive 90/385/EEC through the three 'Zed' Annexes (ZA, ZB & ZC).

It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of an in vitro diagnostic medical device, qualifies as an in vitro diagnostic medical device, while software for general purposes, even when used in a healthcare setting, or software intended for well-being purposes is not an in vitro diagnostic medical device.

In the EU, there are no binding rules as to the delimitation between lifestyle and wellbeing apps and a medical device or in vitro diagnostic medical device.

If a new in vitro diagnostic medical device belonging to Annex II List A is not specifically covered by the common technical specification, the common technical specification for a related device should be taken into account.

If a new in vitro-diagnostic medical device belonging to Annex II List A is not specifically covered by the common technical specification, the common technical specification for a related device should be taken into account.

"In vitro diagnostic medical device" means, essentially, reagents, instruments and equipment for examining tissues or substances from the human body for medical purposes.

"In vitro diagnostic medical device" means, essentially, reagents, instruments and equipments for examining tissues or substances from the human body for medical purpose.

According to this guidance, depending on their intended purpose, apps may fall under the definitions of a medical device32 or of an in vitro diagnostic medical device and consequently will have to comply with the relevant provisions of the aforementioned directives.

Having your in-vitro diagnostic device assessed for compliance with the new EU regulation is mandatory for CE marking and market access within Europe.

What about medical devices and in vitro diagnostic medical devices imported from outside the EU?

Supporting access to European markets for in-vitro diagnostic medical devices under new EU rules.

Refurbishment practices exists for imaging equipment such as magnetic resonance imaging devices, computer tomography devices, in vitro diagnostic devices, patient monitoring devices, and electron microscopes.

Currently, it is not always possible to trace medical devices and in vitro diagnostic medical devices back to their supplier.

It covers in vitro diagnostic medical devices which, in view of their special nature, need specific provisions.

The databank will also streamline the rules for manufacturers placing in vitro diagnostic (IVD) devices on the market.

Negotiations to adopt the new regulations for medical devices and in vitro diagnostic medical devices lasted a period of five years.

To start with, the proposal was considered constructive, not only as it would have been useful for the reasons I have mentioned, but also as it contained many elements which would have contributed to a better qualitative control of in vitro diagnostic devices.

In vitro diagnostic medical devices are taken to mean reagents, instruments and equipment for the examination, for medical purposes, of tissues or substances from the human body.

The present adoption will not have impact on the date of application of the In Vitro Diagnostics Medical Devices Regulation, which becomes applicable from 26 May 2022.

Specimen receptacles are considered to be in vitro diagnostic medical devices.

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;

For the purposes of this definition, invasive sampling devices or those which are directly applied to the human body for the purpose of obtaining a specimen within the meaning of Directive 93/42/EEC shall not be considered to be accessories to in vitro diagnostic medical devices;