Act on Medical Devices

Act No 268/2014 Coll. on Medical Devices came into effect on the First of April, 2015. This Act is a complex legal regulation which covers issue of Medical devices in the Czech Republic.    

Act covers following areas:

TITLE I – INTRODUCTORY PROVISIONS

TITLE II – EXECUTION OF STATE ADMINISTRATION

TITLE III – CLINICAL EVALUATION AND PERFORMANCE EVALUATION

TITLE IV – REGISTRATION AND NOTIFICATION

TITLE V – UNAUTHORISED ATTACHMENT OF THE CE MARK AND CLASSIFICATION

TITLE VI – DISTRIBUTION AND IMPORT

TITLE VII – PRESCRIBING, DISPENSING, AND SALE

TITLE VIII – USAGE

TITLE IX – SERVICING AND REVISIONS

TITLE X – VIGILANCE SYSTEM

TITLE XI – REMOVAL

TITLE XII – MEDICAL DEVICE NATIONAL INFORMATION SYSTEM AND REGISTRY OF MEDICAL DEVICES

TITLE XIII – CONTROL

TITLE XIV – ADMINISTRATIVE OFFENCES

TITLE XV – JOINT, TRANSITIONAL AND FINAL PROVISIONS