Notification of medical device

We provide the professional services and consulting related to notification of the medical devices:

• Consultations related to the national legislative requirements for the notification of a medical device (summarization of documents necessary for a successful notification of a medical device)
• Filling of the forms and completion of documentation for submitting notifications
• Filling of the forms and completion of documentation for submitting change in notification (validity renewal of certificates, change of the manufacturer, …)
• Representation at the State Institute for Drug Control (SIDC)
• Translation of the texts to Slovak language (Instructions for use, labelling)
• Review of the labelling texts and the graphic packaging designs in Slovak language
• Co-operation with the client and SIDC in reporting incidents, errors and failures (vigilance) of medical devices to the SIDC
• Tracking related national legislation and informing on the changes thereof (Regulatory Intelligence)
• Registration of distributor of medical device