Übersetzung für "formale it-spezifikationen überprüfen " (Deutsch → Englisch) :

4.1. All products shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/ or equivalent tests set out in other relevant technical specifications , shall be carried out in order to verify conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.

4.1. All measuring instruments shall be individually examined and appropriate tests set out in the relevant harmonised standard(s) and/or normative documents , and/or equivalent tests set out in other relevant technical specifications , shall be carried out in order to verify their conformity with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.

In order to satisfy the legal requirements laid down in Directive 90/385/EEC, in Directive 93/42/EEC and in Directive 98/79/EC, notified bodies should verify, where relevant, the fulfilment of the essential safety and health requirements contained in Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC , of the requirements contained in Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin and of the common technical ...[+++]specifications for in vitro diagnostic medical devices laid down in Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices

The Commission does not regard the plan proposed as a formal response, since it has not been officially approved by the competent UK authorities, and it says that the plan does not provide the Commission with the information it needs to assess whether the proposed measures satisfy the requirements of the Directive.

Member States shall verify that bodies notified under Article 16 of Directive 93/42/EEC have up-to-date knowledge of the medical devices referred to in Article 1(1), in order to assess the conformity of those devices referred to in Article 1(1) with the provisions of Directive 93/42/EEC and with the specifications laid down in the Annex to this Directive.

14. REQUESTS the Commission to examine how a Community framework of principles should be developed with regard to the use within Community policies of specifications which do not have the status of formal standards;