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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).


Construction products (CE)

Products certification, CE » Conformity assessment (CE)

On 4 April 2011 was published in Official Journal of EU a Regulation of the European parliament and of the Council (EU) no. 305/2011 of 9 March 2011 (Construction Products Regulations – CPR) laying down harmonized conditions for placing of construction products on the market and repealing Council Directive 89/106/EH (Construction Products Directive – CPD).  The Regulation requires, unlike the directive, direct effect and uniform implementation into national law of Member States EU. From 1 July 2013 shall be all construction products, for which a harmonized standard exist or ETA (European Technical Approval) when placed on the market obtained with CE marking and declaration of performance.

 

Application for conformity assessment - harmonized sphere (CPR)
  Manual for clients  
Application for conformity assessment also available in PL and RUS version   NB 1023 - Notification (NANDO system)  
Searching the database of certificates      

PLACING THE CONSTRUCTION PRODUCTS ON THE EU MARKET

Construction products are in accordance with a European Law the „specific product“ and their placing on the market of the European Union and ESVO countries is regulated by the technical regulations, which give for manufacturers, importers, authorized agents and distributors specific duties. Conditions for placing on the market are partly harmonized (same for the whole EU) and partly edited by national legislation of each member state of the EU.

Group of products for which there are harmonized technical specifications fall under REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (EU) No 305/2011 of 9 March 2011 laying down harmonized conditions for placing of construction products on the market and repealing Council Directive 89/106/EEC. For this prescription is used acronym CPR (Construction Products Regulation). Regulation has, unlike the directive, direct effect and requires adaptation of the national law of the Member States of the EU to its content.

Although the CPR regulation entered into force on 24April 2011, most of the articles and annexes are effective from 1 July 2013. From this  day must be all construction products, for which there is a harmonized standard or ETA (European Technical Approval), when placed on the market obtained with CE marking, declaration of performance and detailed technical documentation. Manufacturers may on the basis of certificates of conformity that were issued before 1 July 2013 by CPD, make a declaration of performance in accordance with CPR.

If for the construction product harmonized standard does not exist (or is under preparation), or if the product would substantially deviated and the manufacturer would like to affix the product with CE marking, may request for Technical Assessment Body (TAB) to issue European Technical Assessment (ETA). If the manufacturer does not request for issuing of ETA, considered a product under the national legislation of the country in which the product is placed. Thus assessed product can not be marked with CE.

SERVICES PROVIDED IN CONNECTION WITH CONFORMITY ASSESSMENT OF CONSTRUCTION PRODUCTS

  • Conformity assessment by the Authorized Body No. 224 according to the requirements of national law laying down the technical requirements for selected  construction products
  • Conformity assessment by the Notified Body No. 1023 according to the requirements of  the Regulation 305/2011  laying down the technical requirements for construction products marked with CE
  • Testing of construction products in the Accredited Laboratory No. 1004 and No. 1004.3.
  • Granting licenses for the voluntary certification markITC Certified Quality
  • Standardization services and technical information
  • Certification of management systems (ISO 9001, ISO 14001, OHSAS 18001)
  • Conformity assessment by the inspection body of ITC

CONTACTS

Person Phone fax e-mail
Ing. Petr Karlik +420 577 601 518 +420 577 104 855 pkarlikPostaitczlin.cz


Post address:
Institute for testing and certification, a.s.
Department of construction products certification
trida Tomase Bati 299, Louky, 763 02 Zlin
Czech Republic

The person responsible for accuracy of data: Ing. Petr Karlik

Updated: 10.1.2017
 
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