REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. The Polish Ministry of Health (MOH) must also be notified of all medical and IVD devices which are marketed in Poland.
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb, and III.
TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
AUTHORIZED REPRESENTATIVE: An authorized representative anywhere in the European Union is required to obtain the CE mark.
ADDITIONAL INFORMATION: On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives. The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices
- A manufacturer residing or having its registered office in the territory of the Republic of Poland shall submit a product notification to the President of the Office, at least 14 days before being placed on the market or the first product is submitted for evaluation.
- an authorized representative domiciled in the territory of the Republic of Poland shall submit the product to the President of the Office, at least 14 days before being placed on the market or the first product is submitted for evaluation;
- the distributor or importer with the registered office in Poland which are obligated to perform a registration