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AUTHORIZATION | NOTIFICATION
Authorization under Act No. 22/1997 Coll. (Government Regulation of Czech Republic) on Technical Requirements for Products, as amended, means the authorisation of a legal person to carry out conformity assessment activities for products, including the assessment of activities related to their manufacture or their reuse, as defined in the technical regulations. Authorisation for activities under this Act is granted within the defined scope by the Office for Technical Normalization, Metrology and State Testing.
Notification pursuant to Act No. 22/1997 Coll. (Government Regulation of Czech Republic), on Technical Requirements for Products, as amended, is the authorisation of a legal entity by a Member State of the European Union to carry out activities in assessing the conformity of products with technical requirements and its notification to the authorities of the European Community and to all Member States of the European Union.
Notification according to Act No. 90/2016 Coll. (Goverment Regulation of Czech Republic), on conformity assessment of specified products when they are made available on the market, as amended, means notification of the conformity assessment body by the notifying authority - ÚNMZ to the European Commission and other Member States of the European Union. A notified body may only be a legal person established in the Czech Republic which meets the requirements set out in Section 23 of this Act and can be expected to meet these requirements on a permanent basis, and which provides guarantees of compliance with the obligations relating to the activities of notified bodies and the proper performance of these activities.
Authorization under Act No 258/2000 Coll. (Goverment Regulation of Czech Republic), on the protection of public health, as amended, means a certificate of authorisation of laboratories from the State Institute of Health, the aim of which is to ensure the correct professional level of measurement and assessment for the purposes of assessing the protection of public health and for the effective performance of state health surveillance.
Authorization under Act No. 505/1990 Coll.(Goverment Regulation of Czech Republic) on Metrology means a certificate of competence of an Authorised Metrology Centre to perform verification of specified measuring instruments.
NOTIFIED BODY NO. 1023 (NB 1023) BY LAW 22/1997
On the basis of the Authorization under Act No. 22/1997 Coll. on Technical Requirements for Products, the Institute for Testing and Certification, a.s. acts as a NOTIFIED BODY No. 1023 for conformity assessment activities.
Documents issued by Notified Bodies are the basis for marking products with the European CE conformity mark.
NV No 86/2011 Coll. (Government Regulation of Czech Republic), laying down technical requirements for toys (Directive 2009/48/EC). Notified Bodies entrusted with conformity assessment activities under the previously applicable Government Regulation No 19/2003 Coll. are considered as notified bodies entrusted with activities under Regulation NV No 86/2011 Coll.
NV No. 54/2015 Coll. (Government Regulation of Czech republic), on technical requirements for medical devices (Council Directive 93/42/EEC, as amended). Authorised and notified bodies entrusted with conformity assessment activities pursuant to Government Regulation No. 336/2004 Coll., as amended, shall be deemed to be authorised and notified bodies entrusted with conformity assessment activities pursuant to this Regulation.
The Institute for Testing and Certification, a.s., as Notified Body No. 1023 for the field of conformity assessment of medical devices in accordance with Council Directive 93/42/EEC, may no longer issue new certificates under Directive 93/42/EEC due to its expiry on 26. 05. 2021, but during the transitional period, as provided for in Article 120 of Regulation (EU) 2017/745, may only carry out surveillance activities over certificates validly issued under Directive 93/42/EEC.
NV No. 56/2015 Coll. (Government Regulation of Czech Repubic), on technical requirements for in vitro diagnostic medical devices (Directive 98/79/EC of the European Parliament and of the Council, as amended).
ITC does not currently perform conformity assessment of in vitro diagnostic medical devices in accordance with Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices due to its expiry. Currently, only due diligence of the certificates issued by it is carried out in accordance with the requirements of Article 110(3) of the new Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (IVDR). ITC is in the process of preparing the Application for Notification under the said IVDR.
NOTIFIED BODY NO. 1023 (NB 1023) BY LAW 90/2016
On the basis of the Act No. 90/2016 Coll. on conformity assessment of specified products, the Institute for Testing and Certification, a.s. acts as a NOTIFIED BODY No. 1023 for conformity assessment activities.
Documents issued by Notified Bodies are the basis for marking products with the European CE mark of conformity.
Medical Devices Regulation – Regulation (EU) 2017/745 of the European Parliament and of the Council 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.
Regulation 2016/425, Regulation of the European Parliament and of the Council (EU) on personal protective equipment and repealing Council Directive 89/686/EEC.
NV No. 117/2016 Coll., Government Regulation of Czech Republic on the assessment of the conformity of products with regard to electromagnetic compatibility when made available on the market (Directive 2014/30/EU of the EP and the Council). ITC is notified as a notified body for products determined for conformity assessment according to § 2 of this Regulation.
NV No. 219/2016 Coll., Government Regulation of Czech Republic laying down technical requirements for pressure equipment (Directive 2014/68/EU of the European Parliament and of the Council).
Construction Products Regulation – Regulation No 305/2011 of the European Parliament and of the Council (CPR) laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC.
TECHNICAL ASSESSMENT BODY (TAB)
Institut pro testování a certifikaci, a.s. operates as a technical assessment body (hereinafter referred to as TAB) under Regulation (EU) No 305/2011 of the European Parliament and of the Council (hereinafter referred to as CPR) laying down harmonised conditions for the marketing of construction products and is authorised to issue ETA (European Technical Assessment) documents for construction products listed in the CPR, which may be issued for construction products for which there is no harmonised standard or which deviate from a harmonised standard. The assessment of a product (certification) according to an ETA leads to its CE marking, similar to the assessment according to a harmonised European standard (hEN).
Construction Products Regulation – Regulation (EU) No 305/2011 of the European Parliament and of the Council (CPR) laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EHS.
AUTHORIZED BODY NO. 224 (CZECH NATIONAL LAW)
Institut pro testování a certifikaci, a. s. acts as AUTHORIZED BODY No. 224 for conformity assessment activities.
NV No. 173/1997 Coll., Government Regulation of Czech Republic establishing selected products for conformity assessment.
NV 163/2002 Coll., Government Regulation of Czech Republic laying down technical requirements for selected construction products.
AUTHORIZATION FROM ACT NO. 258/2000 ON THE PROTECTION OF PUBLIC HEALTH
Authorization is granted by the Ministry of Health through the State Institute of Health in accordance with Act No 258/2000 Coll. on the Protection of Public Health. The authorization comprehensively sets out the requirements for the activities of laboratories and the activities of persons in the assessment of health risks in the field of public health protection so that these laboratories and persons provide the highest quality of services for the benefit of the protection and promotion of public health, so that they provide the public health authorities with the highest possible confidence in the results of their work as a basis for the performance of state health surveillance and, at the same time, so that they continuously improve the quality and efficiency of their work.
ITC has an authorized laboratory according to § 83c of Act No. 258/2000 Coll., on the protection of public health, for Set D 3 - Sampling and testing of health safety of products in contact with food and foodstuffs.
AUTHORIZATION FROM ACT NO. 505/1990 COLL., ON METROLOGY
Authorization is granted by the Office for Technical Standardisation, Metrology and State Testing (ÚNMZ) pursuant to Act No. 505/1990 Coll., on Metrology for the verification of the following specified measuring instruments: members of measuring instruments and measuring sets of fluid flow rate - temperature sensors (resistance temperature sensors, as members of measuring instruments and measuring sets of fluid flow rate, in the range of -20 °C to 100 °C.)and heat and cold meters and their components (resistive temperature sensors, as components of heat meters, in the range 0 °C to 420 °C).
AUTHORIZATION SUSPENDED AS OF 10. 6.2017!
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Institut pro testování a certifikaci, a.s. was active in the field of conformity assessment as Notified Body No. 1390 and No. 1023. As of 03. 03. 2021, the competences, rights and obligations of Notified Body No. 1390 were transferred to Notified Body No. 1023. The activities of Notified Body No. 1390 were terminated and Institut pro testování a certifikaci a.s. carries out its conformity assessment activities as Notified Body No. 1023. All documentation issued by Notified Body No. 1390 remains valid.
Institut pro testování a certifikaci, a.s. was active in the field of conformity assessment as Authorized Body No. 212 and No. 224. As of 28 January 2021, the competences, rights and obligations of Authorized Body No. 212 were transferred to Authorized Body No. 224. The activity of Authorized Body No. 212 has been terminated and the Institute for Testing and Certification a.s. carries out its activities in the field of conformity assessment as Authorized Body No. 224. All documentation issued by Authorized Body 212 remains valid.
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