Legislatively, the issue of the medical devices field in Slovakia is regulated by Act No. 362/2011 Coll., On Medicinal Products and Medical Devices and on the Amendment and Supplementation of Certain Acts.In addition, in Slovakia, similarly to the Czech Republic, Government Decree No. 569/2001 Coll., On technical requirements and conformity assessment procedures for in vitro diagnostic medical devices, has been issued.

State Institute for Drug Control

Just like in the Czech Republic, the State Institute for Drug Control is the competent state administration body, so is the State Institute for Drug Control (ŠÚKL) in Slovakia.

Registration requirement

Only manufacturers and authorized representatives based in the Slovakia have a registration obligation. The registration is done by sending a signed registration form, either by mail or at the ŠÚKL registry office.

Notification requirement in the field of medical devices

Manufacturers based outside of Slovakia have a notification requirement in the case of products Class IIA, IIb and III. Under specific conditions, this notification may be filed by another entity based in the EU. If the notification is not made by the manufacturer directly or by an authorized representative, it is necessary to provide a mandate issued by the manufacturer for this operation. In the case of Class I Class I, Active Implantable Medical Devices and In Vitro Diagnostic Medical Devices in vitro, the notification duty is voluntary.

Our services

In case you need help or you want to ensure smooth process of the placing of a medical device on the market or help with the inclusion of a medical device in the system of reimbursementsin Slovakia, do not hesitate to contact us by e-mail: medecorp@medecorp.cz or fill our form here: www.medecorp.cz.