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the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices

On May 5, 2017 the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC was published in the Official Journal of the European Union.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 26 May 2020. By way of derogation, see the Article 123 Entry into force and date of application.


Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices

On May 5, 2017 the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU was published in the Official Journal of the European Union.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 26 May 2022. By way of derogation, see the Article 113 Entry into force and date of application.


Electronic communication – restriction of attachments in ZIP format.

ITC applied the restriction by which it will not be possible to deliver the electronic message with an attachment in ZIP format.

For delivery of large quantities of electronic documents, use a different method than compress into ZIP format.

Thank you for your understanding.


Termination of the contractual cooperation with the company Sastek, Turkey

On 31st August 2015 was terminated a contractual cooperation with the Turkish sales representative of ITC - the company “SASTEK Conformity Assessment Services Co.”.


nanotechnology - the analytical laboratory of ITC engage in cooperation with the Technical University of Dresden

The analytical laboratory of ITC engage in cooperation with the Technical University of Dresden in the project " nanotechnology – guidance on detection and identification of nano-objects in complex matrixes", which is demanded by the French Bureau of Standards (Association Francaise de Normalisation).


Notification




Pursuant to Article 11 of Law No. 22/1997 Collection of laws that lays down technical requirements for products, the authorisation is granted by the Czech Office for Standards, Metrology and Testing (hereinafter UNMZ).

Authorized bodies ensure all the activities connected with the conformity assessment of products according to requirements of the technical regulations. The Authorised bodies become the NOTIFIED BODIES after they are notified by UNMZ to the bodies of the European Community or to the bodies of the Member States of the European Union. Based on the documents issued by the Notified bodies, the products are affixed the CE conformity marking.

NOTIFIED BODY NO. 1023

Institute for Testing and Certification a.s. Zlin, NOTIFIED BODY NO. 1023, possesses the authorities permitting to perform conformity assessment according to the following legislation:

AUTHORIZED BODY 224 (Czech national law)

  • GO No. 173/1997
    Collection of laws that lays down requirements for selected products (as amended by GO No. 329/2002 Coll.)

    authorization

     
  • GO No. 163/2002
    Collection of laws that lays down requirements for selected building products (Commission Directive No. 305/2011)

    authorization + see scope


Person responsible for accuracy of data: Ing. Tatana Pasiakova

Updated: 27.2.2017
 
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