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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).


Confidentiality

Institut pro testování a certifikaci, a.s. (further ITC only) gains during providing of special activities as Authorized Body, Notified Body, Announced Subject (Body) and Accredited Body according to the Act No. 22/1997 Coll., on technical requirements for products and on amendments to certain laws, as amended and Act No. 90/2016 Coll., on conformity assessment of products when made available on the market a lot of confidential information. Handling with this information and principles of confidentiality are subject of the several relevant regulations and special standards. ITC shall meet very strict conditions of information protection and confidentiality, ITC shall always meet these conditions and on the basis of their fulfilment the competency has been granted. To keep secrecy within the meaning of special legal regulations is very strong protection of data (information) confidentiality and it is possible to designate it as stronger protection than the contractual obligation for secrecy keeping.

Decision of European Parliament and European Council No. 768/2008/EC from 09. 07. 2008 on a common framework for the marketing of products, and repealing Council Decision No. 93/465/EEC

  • From the article R17 arises, that the staff of conformity assessment body are obliged to keep the business secret, in case of all information, which have been gained during fulfillment of their duties according to appropriate provisions of national legal regulations. According to this Decision the conformity assessment body, which ITC is, shall ensure that also the activity of its eventual branches or subcontractors does not threaten confidentiality, fair-mindedness (externality) and impartiality of its conformity assessment activities.

Act No. 22/1997 Coll., on technical requirements for products and on amendments to certain laws

  • § 11 determines, as one of the condition for authorization granting, existence of confidentiality obligation for staff (employees).
  • § 20a placing a duty on ITC confidentiality. This Act also determines the inspection (check) on legal conditions meeting and the penalties in case of their infringement.

EN ISO / IEC 17025, Conformity assessment - General requirements for the competence of testing and calibration laboratories

  • From the Article 4.1.5 arises, that laboratory shall have policies and procedures to ensure the protection of its customers’confidential information and proprietary rights, including procedures for protecting the electronic storage and transmission of results and also shall have policies and procedures to avoid involvement in any activities that would diminish confidence in its competence, impartiality, judgment or operational credibility.

EN ISO/IEC 17021 Conformity assessment – Requirements for bodies providing audit and certification of management systems

  • From the Article 4.6 arises, that for gaining the privileged access to information that is needed for the certification body to assess conformity to requirements for certification adequately, it is essential that a certification body keep confidential any proprietary information about a client.

 

EN ISO/IEC 17065 Conformity assessment – Requirements for bodies certifying products, processes and services

  • Article 4.5.1 provides, that certification body shall be responsible, through legally enforceable commitments, for the management of all information obtained or created during the performance of certification activities. Except for information that the client makes publicly available, or when agreed between the certification body and the client (e.g. for the purpose of responding to complaints), all other information is considered proprietary information and shall be regarded as confidential.

Act No. 90/2016 Coll., on conformity assessment of products when made available on the market

  • § 23 determines, as one of the condition for Notification, obligation for staff to maintain confidentiality regarding all information received in the course of their duties under this Act or under the applicable regulations of the European Union.

Conclusion

  • Výše uvedené přísné podmínky a dohled nad jejich dodržováním zaručují klientům ITC dostatečnou garanci ochrany důvěrných informací a zachování mlčenlivosti o těchto informacích při poskytování odborných činností ITC.

 

Contact

Pracovník phone.: fax: e-mail:
Ing. Tatana Pasiakova, marketing 577 601 328 577 104 855 marketingPostaitczlin.cz

 

Post address:
Institut pro testování a certifikaci, a. s.
Marketing department
třída Tomáše Bati 299, Louky, 763 02 Zlín

The person responsible for accuracy of data: Ing. Taťána Pašiaková

Updated: 10.1.2017
 
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