In vitro diagnostic (IVD) devices
Conformity assessment procedure for in vitro diagnostic devices
In Vitro Diagnostic Medical Devices (IVDD) The technical requirements for in vitro diagnostic medical devices are set forth in Directive 98/79/EC o...
EU regulations for in vitro diagnostic devices
In Vitro Diagnostic Medical Devices (IVDD, IVDR) Designation Title No. 98/79/EC (current version) Directive of the European Parliament and of the C...
Czech Republic Regulations on In Vitro Diagnostic Devices
Current Legislation of the Czech Republic Legislation effective as of May 26, 2022 Designation Title No. 90/2016 Coll. (current version) Act on the...
Slovak Republic Regulations on In Vitro Diagnostic Devices
Label Title No. 56/2018 Coll., as amended Act on Product Conformity Assessment, Making a Designated Product Available on the Market, and on Amendme...
Overview of Harmonized Standards for In Vitro Diagnostic Devices
A publicly accessible database of harmonized standards has been integrated into the ITC with financial support from the National Institute of Publi...
Overview of Selected CEN/TC Groups for In Vitro Diagnostic Devices
TC designation / published standards TC name in English TC name in Czech Standards in preparation CEN/CLC /JTC 16 Active Implantable Medical Device...
Overview of Selected ISO/TC Groups for In Vitro Diagnostic Devices
TC designation/ published standard TC name in English TC name in Czech Standards in preparation ISO/TC 198 Sterilization of health care products St...
Overview of Selected ČSN Groups for In Vitro Diagnostic Devices
19 - OPTICAL INSTRUMENTS, CINEMATOGRAPHY AND REPROGRAPHY EQUIPMENT 1900 - 1909 1900 Optics, general 1904 Inspection, measurement, and testing of ...
Overview of Selected STN Groups for In Vitro Diagnostic Devices
19 - OPTICAL INSTRUMENTS, CINEMATOGRAPHY AND REPROGRAPHY EQUIPMENT 1900 - 1909 1900 Optics, general 1904 Measurement control and testing of optic...