Übersetzung für "Custom-made device" in Deutsch

In order to provide clearer evidence of the compliance of custom-made device manufacturers, an explicit requirement for a post market production review system involving incident reporting to authorities should be introduced, as is already in place for other devices, and to enhance patient information, a requirement should be introduced that the ‘Statement’ under Annex VIII to Directive 93/42/EEC should be available to the patient and that it should contain the name of the manufacturer.

In order to better evidence the compliance of custom made device manufacturers there is now an explicit requirement for a post market vigilance system reporting to authorities, as already in place for other devices.

In special cases, we also can provide custom-made devices of component parts.

We are a Czech producer of machines for metal processing and we can produce all kinds of customer made devices.

For custom-made gas devices HEIDEBRENNER examine the possibility if CE-approved components can be used.

Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices;

Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III.

The UDI system should apply to all devices placed on the market except custom-made devices, and be based on internationally recognised principles including definitions that are compatible with those used by major trade partners.

However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices;

For custom-made devices, the manufacturer must undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action.

For custom-made devices, the manufacturer must undertake to review and to document experience gained in the post-production phase, including the provisions referred to in Annex 7, and to implement appropriate means to apply any necessary corrective action.

For custom-made devices, the manufacturer must undertake to review and document experience gained in the post-production phase, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action.

In order to maintain a high level of safety and health protection against the risk of transmitting animal spongiform encephalopathies to patients or other persons via medical devices manufactured utilising non-viable animal tissues or derivatives rendered non-viable, including custom-made devices and devices intended for clinical investigation, it is necessary to update the rules laid down in Directive 2003/32/EC on the basis of the experience with the application of this Directive and to apply them also to active implantable medical devices manufactured utilising tissues of animal origin that fall within the scope of Directive 90/385/EEC.

For custom-made devices and devices intended for clinical investigation which fall under Article 1(1), the statement of the manufacturer or his authorised representative and the documentation in accordance with Annex 6 to Directive 90/385/EEC or Annex VIII to Directive 93/42/EEC, respectively, shall also address compliance with the particular requirements set out in section 1 of Annex I to this Regulation.

Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;

Mass?produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom?made devices;