Product registration

Prior to placing a medical device or in vitro diagnostic medical device on the market, a registration or notification must be made with the relevant Competent Authority.

What is the process of notification or registration of the product?

Before placing a medical device or in vitro diagnostic medical device on the market, the marketing entity is obliged to make a notification to the relevant Competent Authority.

Who is the Competent Authority?

In Poland, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products is the Competent Authority supervising medical devices.

Who can report or notify a medical device?

The manufacturer and an authorised representative residing or based in Poland is obliged to submit a medical device and a medical device for in vitro diagnostics. The notification must be made at least 14 days before the first placing on the market.

A distributor or importer residing in Poland is obliged to notify of the intention to introduce a medical device and a medical device for in vitro diagnostics. The notification shall be made not later than within 7 days from the date of placing the first device on the market.