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ITC
Medical Devices - summarizing the current situation in area of preparation / transfer of notified bodies to the new legislation

The European Associtiation for Medical devices of Notified Bodies (TEAM NB) on web site, in the section "Latest News", published on December 14, 2018 a document called "White Paper: One Year of Application" summarizing the current situation in area of preparation / transfer of notified bodies to the new legislation regarding to Medical Devices Regulation (MDR) and In-Vitro Medical Devices Regulation (IVDR).


Trade Fair AMPER 2020 - cancellation

Dear business friends, unfortunately, we have to inform you that the Fair Amper 2020 is cancelled due to the spreading disease COVID-19. For the fair administration is protecting the health of all involved an absolute priority. However, they would not be able to ensure this in the event of the fair being held at the original date, in particular by the inability to prevent the entry of persons at risk. We apologize for any inconvenience.


TERMINATION OF THE REDIRECTION OF OLD TELEPHONE NUMBERS

Dear clients,

As of 31 December 2019, will be TERMINATE THE REDIRECTION OF OLD TELEPHONE NUMBERS of ITC employees who moved from the former Zlín-Louky workplace building to the new Zlín, area Svit, Building 113 workplace.

New telephone numbers can be found on the website of specific service, in the CONTACTS section of the ITC website or on phone request.

For troubleshooting and any questions please contact the ITC’s infoline at +420 572779922.


New tests for measurement of formaldehyde emissions

Laboratories of ITC offers newly accredited test of formaldehyde emission by the chamber method, based on standard EN 717-1.


Determination of resistance to cutting by sharp objects

Laboratory of textile has successfully accredited testing procedure EN ISO 13997 - Determination of resistance to cutting by sharp objects. The test is performed mainly on protective gloves and similar PPE.

For further information and testing, please, contact our laboratory: textile@itczlin.cz, phone: +420 577 601 268.


Medical devices

Products certification, CE » Conformity assessment (CE)

Any medical device may be introduced to the EU market only provided that an assessment of the conformity of its characteristics with the requirements laid down by Council Directive 93/42/EEC has been carried out and that the outcome of this assessment is the finding that the medical device meets the basic requirements, has been provided - except for specified exceptions - with the CE marking, satisfies the additional relevant requirements (e.g. information concerning its usage) and that the manufacturer or authorised representative has issued a written EC declaration of conformity to this effect. Institute for testing and certification is a member of TEAM-NB and is a  signature of an ethics code (Code of Conduct).

Preliminary questionaire   Manual for clients
Application for conformity assessment   Searching the database of certificates
GFA (general framework agreement)   News
Legislation and  other documents for conformity assessment      

SERVICES PROVIDED IN CONNECTION WITH CONFORMITY ASSESSMENT OF MEDICAL DEVICES

  • Conformity assessment by the Notified Body No. 1023 according to the requirements of the:
    • Council Directive 93/42/EEC, laying down the technical requirements for medical devices
    • Council Directive 2006/95/EC, laying down the technical requirements for low voltage electrical equipment
    • Council Directive 2004/108/EC, laying down the technical requirements for products in terms of their electromagnetic compatibility
  • Testing in the Accredited Laboratory No. 1004 and No. 1004.3
  • Granting licenses for voluntary certification mark “ITC certified quality
    ITC grants a license for the use of the quality mark, which is granted to the products where high standard of safety and quality parameters has been proved by certification and where meeting the prerequisites of the producer for continuous quality compliance has been proved through inspection visits.
  • Standardization services - analyses of technical information
  • Certification of management systems (ISO 13485, ISO 9001, ISO 14001, OHSAS 18001)
  • Technical inspection - statistical inspections, inspection certificates

PRODUCTS ASSESSED IN ITC ACCORDING TO the Council Directive 93/42/EEC

Institute for Testing and Certification, Inc. is notified as the Notified Body No. 1023 for conformity assessment of all medical devices.

CONTACTS

Person Phone e-mail
Tomas Zavisek, Ing.,
head of department medical devices certification
+420 572 779 955 tzavisekPostaitczlin.cz


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

Person Phone fax e-mail
Remeteiova Lydia,
deputy of head of department medical devices certification
+421 253 421 046 +421 253 421 032 lremeteiovaPostaitczlin.cz
Luptakova Zuzana, Ing.,
deputy of head of department medical devices certification
+421 253 421 032 +421 253 421 032

zluptakovaPostaitczlin.cz


Post address:
Institut pro testování a certifikaci, a. s.
Department of medical devices certification
Mlynské Nivy 54
821 05 Bratislava
Slovak Republic

The person responsible for accuracy of data: Ing. Tomas Zavisek

Updated: 30.1.2020
© ITC - Institut pro testování a cetfifikaci, a.s. | Tel.: +420 572 779 922 | E-mail: itc@itczlin.cz
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