A comprehensive act regulating both the MDs and IVDs is finally here. The new Act No. 375/2022 Coll., on medical devices and in vitro diagnostic medical devices reflects the considerable similarity between MDR and IVDR and thus has retained the systematic structure of Act No. 89/2021 Coll. Below we would like to introduce you to the main changes brought by the new act.
In the field of IVD, this is an adaptation act, which mainly fills the space left by the IVDR itself for national legislation. In particular, it establishes the national administrative authorities for the exercise of the powers conferred, defines the offenses and the applicable administrative fines, introduces the obligation of distributors register, specifies language related requirements for the submission of necessary documentation and information, defines rules for the activities of ethics committees, and addresses the issue of performance studies. The act also introduces central registration and evaluation of serious adverse events and safety corrective actions, adds procedures for the handling of devices posing unacceptable risks to health and safety and finally regulates areas not covered by the IVDR, i.e. prescribing, dispensing, use and servicing.
The area with the greatest amount of change related to MDR adaptation is delinquency. Act No. 89/2021 Coll. did not contain all offenses for violation of the obligations under the MDR, the new Act on MDs and IVDs therefore corrects this situation and redefines that an offense with a corresponding sanction is e.g. failure to comply with the relevant common specifications, absence of a review of coordinated assessment procedure as part of the technical documentation, failure to take the necessary corrective actions, violation of the obligation of the manufacturer of a custom-made device to attach the necessary declaration to the device or its attachment in a language other than Czech, or failure of sponsor to conduct a clinical investigation in accordance with the requirements of the MDR.
As part of the distributor's reporting obligation, the requirement to provide the UDI-DI and the intended purpose of distributed MDs does not apply to pharmacy care providers. The exemption from the requirements for servicing personnel now applies only to a Risk Class I device without a measuring function that is not an electrical device. It is therefore being narrowed. This is similarly the case for repairs. In the area of inspections, this obligation is now also foreseen for devices that include lifting equipment (lifting inspections).
Author: Aneta Dostálová