Medical Devices (MDD)
Conformity assessment procedure under Regulation (EU) 2017/745
Regulation (EU) 2017/745 Council Directive 93/42/EEC has been partially repealed and replaced by Regulation (EU) 2017/745 of the European Parliamen...
EU Regulations on Medical Devices
MEDICAL DEVICES – (MDD, MDR) Designation Title No. 93/42/EEC (current version) repealed and replaced by Regulation (EU) 2017/745 of the Eur...
Czech Republic Regulations on Medical Devices
Regulations effective May 26, 2021 Designation Title No. 90/2016 Coll. (current version) Act on the Conformity Assessment of Specified Products Wh...
Overview of Harmonized Standards for Medical 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 Medical 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 Medical 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...
Overviews of Selected ČSN Groups for Medical Devices
19 - OPTICAL INSTRUMENTS, CINEMATOGRAPHY AND REPROGRAPHY EQUIPMENT 1900–1909 1900 Optics, general 1904 Inspection, measurement, and testing of op...
Overviews of Selected STN Groups for Medical Devices
19 - OPTICAL INSTRUMENTS, CINEMATOGRAPHY AND REPROGRAPHY EQUIPMENT 1900 - 1909 1900 Optics, general 1904 Measurement control and testing of optic...