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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).


PF 2021

Dear Clients, we would like to thank you for your confidence in cooperation with our company during the past year.

We would like to use this opportunity to wish you good health, happiness and success in 2021, both personally and professionally.


Relocation of part of ATL 1004 - Physical Laboratory from the Central Laboratories of Louky Zlín to the workplace in the Svit 113th building

Dear clients. As of 09.11.2020, part of ATL 1004 - Physical Laboratory was completely relocated from the central laboratories of Louky Zlín to the ITC workplace in the Svit 113th building, Zlín. The original telephone numbers will be valid until 31.12.2020. At the same time, new telephone numbers will be launched next week, which will be published on the ITC website in the Contacts section. Now please contact specific employee of the physical testing laboratory by e-mail, mobile phone number, or you can contact Mrs. Jarmila Vyorálkova from the secretariat of the Physical Laboratory by phone +420 572 779 989 or e-mail jvyoralkova@itczlin.cz. Thank you for your understanding.


COMMISSION REGULATION (EU) 2020/1245 of 2nd September 2020 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food entered into force on 23rd September 2020

This regulation has significantly changed the scope of evaluation of elements and primary aromatic amines and the way of evaluation of articles for repeated use – HERE you can find more information. ITC labs are already prepared to test and evaluate the articles according to new rules.

 

Contact:
Mrs. Sarka Kopeckova, skopeckova@itczlin.cz,
tel: +420 577 601 705

Mr. Daniel Vit, dvit@itczlin.cz,
tel. +420 577 601 704

MORE INFORMATION


new ICP spectrometer in ITC labs

Analytical laboratory has recently purchased new ICP spectrometer Agilent 5800. The spectrometer is intended for determination of elements in water solutions, leachates and mineralisates. It is used mainly for evaluation of food-contact materials, products for children, material analysis of plastics, rubbers and metals. Spectrometer can be also used for determination of elements, which are limited in electro-products by RoHS 3 directive. High sensitivity enable evaluation of products according to many national and European legislations.  


Medical devices

CERTIFICATION OF PRODUCTS | 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: 8.1.2021
© ITC - Institut pro testování a cetfifikaci, a.s. | Tel.: +420 572 779 922 | E-mail: itc@itczlin.cz
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