Cyprus Medical Devices Competent Authority the regulatory authority for market surveillance of medical devices responsible for inspecting manufacturers, importers and distributors and their products, taking appropriate action when non-compliant products are identified. In this context, it is a member of the relevant European Groups through which the National Competent Authorities inform each other when actions are taken on non-compliant products. Such actions include recall of non-compliant products from consumers, withdrawal of products from the market, destruction of dangerous products and imposition of fines or other penalties. In addition, information and data are exchanged through the Vigilance system. This allows other countries to take appropriate security measures. Finally, national Competent Authorities investigate consumer complaints about product safety and problems.

Manufacturers should play an active role during the post-market phase by systematically and actively gathering information from post-market experience with their devices in order to update their technical documentation and cooperate with the national competent authority.

Manufacturers have the responsibility to inform the competent authority of any serious adverse event related to a product bearing their name by completing and sending the appropriate form (Manufacturer incident report 2020).

More information on the incident reporting (Vigilance) procedure and post-market surveillance is provided in CHAPTER VII of Regulations (EU) 2017/745 and 2017/746.
The forms and explanatory text for the vigilance system are set out in the relevant European Commission guidelines (2.12 Post-Market surveillance).