DATABÁZE INFORMAČNÍCH POVINNOSTÍ PODNIKATELŮ

Legislation	Description of duty	§, para.	Form of fulfilment	Method of fulfilment	Frequency of performance (per year)
Act No 375/2022 Coll., on medical devices and in vitro diagnostic medical devices	Legal obligation of the manufacturer of a custom-made medical device to notify the State Institute for Drug Control of the activity within 30 days of the start of production, to provide a list of generic groups of manufactured medical devices supplied on the market in the Czech Republic within 6 months of the start of production of custom-made medical devices; to provide information on the termination of the activity.	§ 5(2)(c); § 8(4)	form	electronically: > data box > information system of the office	1 / year
Act No 375/2022 Coll., on medical devices and in vitro diagnostic medical devices	Obligation for certificate; application by the manufacturer or authorised representative for a certificate of free sale for export purposes showing that the medical device concerned bears the CE marking in accordance with the legislation.	§ 5(2)(j); § 10(4)	form	electronically: > data box > information system of the office	1 / year
Act No 375/2022 Coll., on medical devices and in vitro diagnostic medical devices	Obligation of the healthcare provider to report the establishment of the ethics committee (within 30 days of its establishment), changes in its composition and information on the termination of the ethics committee.	§ 13(1)	form	electronically: > data box > information system of the office	cannot be determined
Act No 375/2022 Coll., on medical devices and in vitro diagnostic medical devices	The sponsor of a study on the functional suitability of an in vitro diagnostic medical device is obliged to provide the State Institute for Drug Control with an annual report on the progress and safety evaluation of the study by 31 January of the following year at the latest.	§ 20(2)	Announcements	electronically: > data box > information system of the office	1 / year
Act No 375/2022 Coll., on medical devices and in vitro diagnostic medical devices	The sponsor of a clinical trial of a medical device is obliged to provide the State Institute for Drug Control with an annual report on the course and evaluation of the clinical trial by 31 January of the following year at the latest.	§ 20(2)	form	electronically: > data box > information system of the office	1 / year
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