With effect from 18.07.2020, ITC extended the scope of notification to perform the activities of Notified Body No. 1023 for the assessment of products under Act 90/2016 and under Regulation 2016/425/EU of the European Parliament and of the Council regarding to personal protective equipment for "Equipment providing respiratory system protection - Filtering half masks to procect against particles and conformity assessment procedures / modules referred to in Article 19 (b), (c) to (i) of Annexes V and VII to the Directive 2016/425/EU: "EU type-examination (Module B) - Annex V"; "Conformity to type based on internal production control plus supervised product checks at random intervals (Module C2) - Annex VII ".
- PPE certification:
Ing. Elena Tomanová email@example.com +420572779928
download: notification (NANDO)
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).
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 firstname.lastname@example.org. Thank you for your understanding.
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.
Mrs. Sarka Kopeckova, email@example.com,
tel: +420 577 601 705
Mr. Daniel Vit, firstname.lastname@example.org,
tel. +420 577 601 704
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