Primjeri korištenja Reference laboratories na Engleski i njihovi prijevodi na Hrvatskom
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European Union reference laboratories.
EU reference laboratories shall satisfy the following criteria.
European Union reference laboratories shall.
EU reference laboratories shall be subject to controls, including on-site visits and audits, by the Commission to verify compliance with the requirements of this Regulation.
Those laboratories therefore should act as European Union reference laboratories for the purposes of this Regulation.
The EU reference laboratories shall satisfy the following criteria:(a).
The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the establishment of requirements for national reference laboratories in addition to those laid down in paragraphs 2 and 3 of this Article.
European Union reference laboratories provided for in Article 93;(b).
The Commission is empowered to adopt delegated acts in accordance with Article 144 to supplement this Regulation concerning the establishment of responsibilities andtasks for national reference laboratories in addition to those provided for in paragraph 1 of this Article.
European Union reference laboratories and reference centres for animal welfare.
Animal health laboratories: the European Parliament envisaged(amendments 150-155) requirements for official animal health laboratories, including provisions on the laboratory network andrequirements on the official laboratories as well as national and Union reference laboratories.
Member States may designate national reference laboratories as part of a network of laboratories working within the Union.
For specific devices, or a category or group of devices, or for specific hazards related to a category or group of devices, the Commission may designate,by means of implementing acts, one or more European Union reference laboratories, hereinafter referred to as'EU reference laboratories', that satisfy the criteria set out in paragraph 3.
The EU reference laboratories shall form a network in order to coordinate and harmonise their working methods as regards testing and assessment.
The European network of laboratories shall consist of Union reference laboratories, national reference laboratories and official animal health laboratories. .
Where appropriate, reference laboratories should be established with a view to providing expert, impartial technical advice and conducting tests on products required in relation to market surveillance activities.
The Commission shall, by means of implementing acts, designate European Union reference laboratories in the cases where a decision has been taken to establish such a laboratory in accordance with Article 92.
European Union reference laboratories and European Union reference centres shall be subject to Commission controls to verify compliance with the requirements of Article 93(3), Article 94, and Articles 95(3) and 97(3).
Text proposed by the Commission Amendment 1. Grants may be awarded to the European Union reference laboratories referred to in Article 32 of Regulation(EC) No 882/2004 for the costs they incur to implement the work programmes approved by the Commission.
European Union reference laboratories should be enabled to verify compliance of such devices with the applicable common technical specifications, when such common technical specifications are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.
To set up and manage a network of national reference laboratories and publish a list of the participating national reference laboratories and their respective tasks;
EU reference laboratories should be enabled to verify by laboratory testing the performance claimed by the manufacturer and the compliance of devices presenting the highest risk with the applicable CS, when such CS are available, or with other solutions chosen by the manufacturer to ensure a level of safety and performance that is at least equivalent.
Collaborate with the European Union reference laboratories, and participate in training courses and in inter-laboratory comparative tests organised by these laboratories;(b).
In particular, EU reference laboratories will be funded in order to help them bear the costs arising from the implementation of the Commission's work programmes.
(e) to set up and manage a network of national reference laboratories after consulting with the national authorities and publish a list of the participating national reference laboratories and their respective tasks;
European Union reference laboratories shall be responsible, in accordance with annual or multiannual work programmes approved by the Commission, for the following tasks.
The Commission shall designate Union reference laboratories for illnesses for which, owing to their impact on health or the economy, this is necessary to achieve the objectives of this Regulation.
European Union reference laboratories shall publish the list of the national reference laboratories designated by the Member States in accordance with Article 100(1).
The manufacturer shall undertake to keep available to the competent authorities and the EU reference laboratories the documentation allowing an understanding of the design, manufacture and performances of the device, including its expected performance, so as to allow assessment of conformity with the requirements of this Regulation.
European Union reference laboratories and European Union reference centres shall be subject to Commission controls to verify compliance with the requirements of Article 91(3), Article 92, 93(3), Article 95(3) and Article 96.